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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Carcinoma, Ductal Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ 2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer 3. Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen Men 2. Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years 3. Pregnant women 4. Immunocompromised 5. Poorly controlled insulin dependent diabetes 6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma 7. Breast cancer that involves skin or chest wall 8. Multifocal or Multicentric breast cancer 9. Invasive lobular carcinoma 10. Diffuse microcalcifications on mammography 11. Invasive carcinoma with extensive intraductal component (EIC) 12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy 13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy 14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not patients with micro-metastases) 15. Subglandular or submuscular breast implants (does not patients having implants placed AFTER intra-operative radiotherapy)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Carcinoma Breast Stage IV Female gender 2. Age >= 18 years 3. ECOG performance status < 2 4. Histologically proven diagnosis of breast cancer 5. Locally advanced and/or metastatic disease 6. Life expectancy of three months or longer 7. No concurrent second malignancy (except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the cervix or contralateral breast cancer). Any prior second malignancy must be in remission for >= 5 years (except for contralateral breast cancer). 8. No other serious illness or medical condition including History of documented congestive heart failure; angina pectoris requiring antianginal medication; evidence of recent (< 6 months) transmural infarction on electrocardiogram (ECG); poorly controlled hypertension (e.g. systolic > 180 mmHg or diastolic greater than 100 mmHg); clinically significant valvular heart disease; or high-risk uncontrolled arrhythmias Chronic lung disease History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent, including psychotic disorders, mental retardation, and dementia Active concurrent infection 9. No symptomatic central nervous system (CNS) metastases 10. No rapidly progressive visceral metastases requiring immediate chemotherapy 11. No concurrent anti-cancer treatment is allowed. 12. Prior investigational biological agents are allowed, with the exception of anti-HER-2 therapy for any reason. 13. Previous hormonal therapy is allowed, as adjuvant and/or for metastatic breast cancer (MBC). 14. Adjuvant and MBC chemotherapy allowed, provided that a minimum of 4 weeks interval has elapsed between last chemotherapy administration and first study drug dose. All patients who, in the opinion of the investigator, could benefit from single agent Herceptin® and are not considered suitable for treatment with chemotherapy plus Herceptin® can be considered for this protocol. 15. A maximum cumulative dose of previous doxorubicin < 360 mg/m2 or a maximum cumulative dose of epirubicin < 720 mg/m2 16. Concomitant use of bisphosphonates is allowed, however if bisphosphonates are started during the trial for worsening bone pain, patients should be assessed for possible progressive disease. 17. Adequate organ function as defined by Neutrophils >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Bilirubin <= 1.5 x upper limit of normal (ULN) Transaminases <= 2.5 x ULN or <= 5 x ULN if liver metastasis Creatinine <= 1.5 x ULN 18. Overexpression of HER-2 in the invasive component of the primary tumor, according to one of the following definitions
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Postmenopausal women with a history of AJCC Stage 0, I, II or III breast cancer, with no clinical evidence of disease, after completion of all planned adjuvant therapy. Patients must not have received anti-estrogen therapy as part of their adjuvant treatment. Patients with a history of invasive ER and/or PR-positive breast cancer are eligible only if they have not received an anti-estrogen as part of adjuvant therapy, and they are at least 2 years from the time of their primary surgery Patients must have completed all planned adjuvant therapy, including surgery, chemotherapy, and radiation therapy, at least 4 weeks prior to treatment. There is no limit as to the amount of time that may have passed since completion of adjuvant therapy and initiation of treatment Patients must be postmenopausal, as defined by either: 1. No spontaneous menses for at least 5 years; women who have had a hysterectomy in this group, but have intact ovaries must have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range 2. Spontaneous menses within the past 5 years, but amenorrheic (e.g. spontaneous or secondary to chemotherapy, radiation therapy or hysterectomy) for at least 12 months, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range 3. Bilateral oophorectomy Patients must have a history of breast cancer confirmed by the Department of Pathology at Memorial Sloan-Kettering Cancer Center Patients must be at least 18 years old, and must be able to give written informed consent Karnofsky performance status > 80% Laboratory parameters: WBC =>3.0 x 106 cells/ml serum bilirubin <= 1.5 mg/dl serum creatinine <= 1.5 mg/dl serum AST (SGOT) <= 2x upper institutional normal CEA and CA15-3 within institutional normal limits Prior history of bilateral mastectomy Prior history of ovarian or endometrial cancer Prior or current history of osteoporosis, as defined by a lumbar-spine bone mineral density < 2.5 SD below the mean value for normal premenopausal women Use of bisphosphonates or calcitonin within the past 3 months Prior history of venous thrombosis or pulmonary embolism Patients with unstable angina or New York Heart Association Class III or IV heart disease Prior hormonal therapy within the past 3 months
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Personal risk factors (any of the following) Personal history of breast and/or ovarian cancer, regardless of age Prior breast biopsy that included any of the following high risk, benign lesion: Lobular carcinoma in-situ, Atypical ductal hyperplasia, Atypical lobular hyperplasia, Atypical columnar hyperplasia Positive test for known mutations of BRCA 1 or 2 genes, regardless of age History of chest irradiation for treatment of non-breast disease (EX:lymphoma, lung cancer) at least 15 years prior to enrollment. Family history (over 30 years of age with any of the following, some exceptions may appy) Ashkenazi Jewish ancestry, regardless of age Any history of male breast cancer on the maternal or paternal side Breast and ovarian cancer in a close relative (mother, sister, daughter) Breast or ovarian cancer in more than one close relative (mother,sister daughter) Breast cancer in a close relative (mother, sister, daughter) with early onset(<50 years of age) Patient does not meet any of the Patient has had breast augmentation, except for unilateral augmentation done for prior mastectomy Patient has suspected or confirmed pregnancy Patient has large breasts that cannot be adequately imaged on the 19 x 23 cm detector surface of the GE Senographe 2000D digital mammography unit
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Histologically confirmed invasive breast cancer by fine needle aspiration or biopsy Locally advanced or early metastatic disease Clinically or radiographically measurable disease Planning to receive neoadjuvant chemotherapy for locally advanced or early metastatic disease Hormone receptor status Not specified Age Not specified Sex Not specified Menopausal status Not specified Performance status Not specified Life expectancy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed advanced or metastatic breast cancer postmenopausal females with amenorrhoea > 12 months and an intact uterus FSH levels within postmenopausal range or have undergone a bilateral oophorectomy ER &/or PR positive previous adjuvant hormone therapy > 12 months prior to enrolment previous adjuvant chemotherapy > 6 months prior to enrolment measurable disease according to and/or non measurable bone disease life expectancy of at least 12 weeks World Health Organisation (WHO) performance status (PS) of 0 to 1 Male life-threatening metastatic visceral disease evidence of clinically active interstitial lung disease ER and PR negative treatment with LHRH analogues < 3 months prior to enrolment patients who have restarted menses or do not have FSH levels within the postmenopausal range treatment with strontium (or other radio pharmaceutical) within the previous 3 months Treatment with hormonotherapy and/or chemotherapy for advanced disease extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of bone marrow, e.g. whole of pelvis or half of spine)
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Locally Advanced Breast Cancer Postmenopausal women 2. Primary locally invasive breast cancer 3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells. 4. Post menopausal status 5. Tumor measurable by clinical examination, mammography and ultrasound Prior treatment with letrozole or tamoxifen. 2. Patients with bilateral breast tumors 3. Patients who are eligible for breast conserving surgery 4. Evidence of inflammatory breast cancer or distant metastasis. 5. Other concurrent malignant disease 6. Concomitant anti-cancer treatments such as chemotherapy Other protocol-defined
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, DCIS Patients must have suspicion of DCIS or early invasive breast cancer on mammography Patients must have histologically confirmed diagnosis of DCIS or early invasive breast cancer on core biopsy for final registration Patients must be over 18 years of age "Patients must be postmenopausal as defined by one of the following 1. Prior bilateral oophorectomy OR 2. > 12 months since LMP with no prior hysterectomy OR 3. a & b not applicable AND age >=50 Patients must be positive for either ER or PR or both Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Patients must not have diagnosis of osteoporosis (T-score -2.5 according to the WHO)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Neoplasms Postmenopausal women with metastatic breast cancer, or loco-regional disease recurrence not amenable to treatment by surgery or radiotherapy Postmenopausal status will be defined by any of the following no spontaneous menses for at least 5 years spontaneous menses within the past 5 years but amenorrheic for at least 12 months and estradiol and/or FSH values in the postmenopausal range (while off aromatase inhibitor therapy; levels can have been taken while on tamoxifen but in this case estradiol should be the parameter assessed) bilateral oophorectomy radiation castration and amenorrheic for at least 3 months the use of an LHRH agonist throughout the duration of the trial (for example goserelin 3.6 mg s.c. monthly) Age ≥ 18 years old Patients whose tumors are either estrogen-receptor (ER) and/or progesterone-receptor (PgR) positive (10% or more infiltrating cancer cells exhibiting nuclear staining). Patients will be regarded as ER or PgR positive as long as at least one of the tissues assessed was positive. A positive biochemical test is also acceptable Patients must have a WHO Performance Status Grade 0-2 Patients with tumors which are both estrogen and progesterone receptor negative, or estrogen receptor negative and progesterone receptor unknown or estrogen receptor unknown and progesterone receptor negative Patients with a history of adrenalectomy or hypophysectomy Patients who developed progressive disease while being treated with an aromatase inhibitor Patients with any of the following Absolute Neutrophil Count < 1.5 x 109/L Hemoglobin < 9 g/dl Platelet count < 100 x 109/L AST and ALT > 3 times the upper limit of normal or > 5 times the upper limit of normal if liver metastasis are present Bilirubin > 1.5 upper limit of normal Creatinine > 1.5 x upper limit of normal
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Diagnosis of breast cancer T2-T4c, any N, M0 disease Clinically staged, as documented by the treating physician, as 1 of the following T4a-c disease for which modified radical mastectomy with negative margins is the goal T2 or T3 disease for which conversion from needing mastectomy to breast conservation is the goal T2 disease for which lumpectomy at first attempt is the goal Primary tumor must be palpable and measure > 2 cm by tape, ruler, or caliper measurements in at least one dimension Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy No inflammatory breast cancer, defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema) No distant metastasis (M1)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Migraine Headache Migraine Headache Pregnancy and lactation Pre-medication within six hours of being enrolled in the study More than six prior headaches per month Allergy to the study drugs Non-migraine headache Substance abuse Alcohol abuse Diabetes mellitus, or a coexisting condition that might expose the patients to a disproportionately increased risk of a significant adverse event: ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension (blood pressure >160/95), epilepsy, use of cimetidine, dopamine agonist, cyclopsorin, or oral hypoglycemic agents, hepatic or renal failure, and thyroid disorder
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer . Female patient with a new histological diagnosis of DCIS only. OR 1b. Female patient with a new histological diagnosis of invasive carcinoma of the breast and no evidence of metastatic disease. 2. Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re excision). 3. Negative axillary node involvement including micrometastasis <= 0.2mm or positive cells only identified by IHC as determined either by: (i) sentinel node biopsy (ii) axillary node dissection or (iii) clinical exam for patients with DCIS only Age < 40 years. 2. A known deleterious mutation in BRCA 1 and/or BRCA 2. 3. Tumour size > 3 cm in greatest diameter on pathological examination (including both the invasive and non-invasive component). 4. Tumour histology limited to lobular carcinoma only. 5. History of cancer Patients with another active malignancy or malignancy treated < 5 years prior to randomization are excluded Patients with a prior diagnosis of invasive or non-invasive breast cancer in either breast are excluded regardless of disease free interval. Patients with concurrent invasive or non-invasive contralateral breast cancer are also excluded Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial. 6. More than one primary tumour in different quadrants of the same breast. 7. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation. 8. Presence of an ipsilateral breast implant or pacemaker. 9. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment. 10. Estrogen receptor status (ER) not known. 11. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast. 12. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy. 13. Currently pregnant or lactating. 14. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol. 15. Geographic inaccessibility for follow-up. 16. Inability to localize surgical cavity on CT (i.e., no evidence of surgical clips or seroma). 17. Inability to adequately plan the patient for the experimental technique
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed infiltrating carcinoma of the breast meeting any of the following T1-3, any N disease Proven ductal carcinoma in situ Unresected disease Planned mastectomy as definitive surgical procedure Known or suspected metastatic disease allowed provided mastectomy is planned Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy) No inflammatory breast cancer or other T4 features Successful baseline ductogram Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Diagnosis of ductal carcinoma in situ (DCIS) on core biopsy No evidence of contralateral breast disease or palpable masses on breast examination No presence or suspicion of invasive cancer, including contralateral invasive cancer, on core biopsy and MRI No documented ipsilateral axillary adenopathy Planning to undergo lumpectomy or mastectomy Estrogen receptor (ER)-positive tumor by immunohistochemistry Female patient Premenopausal or postmenopausal Postmenopausal is defined by any of the following No spontaneous menses for >= 1 year
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Breast Neoplasms Fibrocystic Disease of Breast Mammaplasty first visit to a Breast Disease Ambulance for consultation no pregnancy no severe heart disease (EF > 40%) no therapy with digitalis no acute/chronic inflammatory disease (e.g. RA, M. Crohn) no dysfunction of the Hypothalamo-Pituitary-Adrenal system no severe mental disorder
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 20.0-74.0, Lymphoma, Low-Grade Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.) Patients with measurable lesions (> 1.5 cm) Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies) ECOG performance status: 0 Patients with adequately maintained organ functions Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever </=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma Patients who are positive for HBs antigen, HCV antibody, or HIV antibody Patients who received G-CSF or transfusion within 1 week before the registration Patients with the history of allergies to purine nucleoside analogue Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy) Patients who had progressive disease within 6 months of receiving therapy including rituximab Women who are pregnant, of childbearing potential, or lactating Patients who do not agree to practice contraception
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltrative Breast Cancer patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy) approval and informed consent chemotherapy locoregional radiotherapy prevalent axillary lymph node
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Early Breast Cancer Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole WHO performance status 0, 1 or 2 Provision of written informed consent Recurrence of breast cancer, inflammatory rheumatism treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin Diabetes treated by insulin Severe renal or hepatic disease Known hypersensitivity to anastrozole
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Neoplasms Histologic Documentation Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status In the case where invasive cancer is present, the invasive cancer's pathology will be used regardless if DCIS is also present. 2. Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist. Radiation therapy should begin within 12 weeks from definitive surgical procedure 6 weeks after chemotherapy, if chemotherapy given first The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following should not be entered in this study: 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region. 1. b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region. 2. Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement 3. Histological evidence of: 1. Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible. 2. EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion 7, 55. 3. Invasive Lobular Carcinoma 4. Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible 56, 57. 5. Infiltrating papillary carcinoma 6. Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin. 4. History of cosmetic or reconstructive breast surgery 5. Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. 6. Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years. 7. Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications 8. Women who are pregnant
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer postmenopausal women on or off hormone replacement therapy at high risk of developing breast cancer determined by family or personal history postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer History of histologically confirmed breast cancer, meeting 1 of the following staging Ductal carcinoma in situ Stage I-III invasive breast cancer At least 3 months since completion of all intended local and systemic therapy, including mastectomy or lumpectomy with or without radiotherapy, adjuvant chemotherapy, and/or endocrine therapy May have declined recommended treatment provided all treatment intended/agreed upon by the patient and treating physician was completed ≥ 3 months ago At least 1 healthy intact breast No prior radiotherapy or mastectomy Prior biopsies allowed Any hormone-receptor status Female
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 65.0-999.0, Stage I Breast Cancer Stage I ductal breast cancer Status post lumpectomy/partial mastectomy and axillary dissection or sentinel lymph node biopsy Age over 65 Pathologically negative margins No lymphovascular invasion Able to begin radiation treatment 3-8 weeks post surgery, unless receiving chemotherapy first Lumpectomy cavity is visible in CT Patient is female Lymphovascular invasion Positive nodes or tumor size greater than 2 cm Positive margins Age less than 65 Patient is male
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-45.0, Breast Cancer Histologically or cytologically confirmed adenocarcinoma of the breast and appropriate for treatment with Doxorubicin and Cyclophosphamide. 2. Age > 18 years and <45 years. 3. ECOG performance status of 0 to 2. 4. Signed informed consent. 5. Premenopausal: defined as regularly occurring menstrual cycles or serologic estradiol and FSH levels consistent with premenopausal status Patients with distant metastatic disease will be excluded. 2. Pregnancy or breast feeding (women of childbearing potential must have a negative pregnancy test). Women of childbearing potential must be willing to consent to using effective contraception (oral contraceptive pill or implant or barrier method) while on treatment and for a 30 days after taking the last dose of chemotherapy. 3. Male sex will be excluded. 4. Use of agent designed to suppress ovarian function (i.e. LHRH agonist). 5. Use of exogenous estrogen (hormone replacement therapy) will be prohibited with the exception of topical vaginal preparations (as deemed necessary by the treating physician) and oral contraceptives
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-50.0, Schizophrenia Schizoaffective Disorder Schizophreniform Disorder(Not in Manic Phase) Female participants of potential child-bearing age (Pre-menopausal and Post-menarche) Female participants who meet the MINI (Mini International Neuropsychiatric Interview for DSM-IV) diagnostic for current psychotic disorder or have a current DSM-IV diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase) Female participants with a PANSS positive score greater than 15 and/or a PANSS negative score greater than 15 Female participants who are able to give informed consent Female participants receiving 2-20mg daily Risperidone equivalents for at least 4 weeks Female participants who are pregnant or lactating Female participants with known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, history of thromboembolic disorders, severe renal failure, severe hepatic failure, cardiac disease, epilepsy or other serious medical conditions which would contraindicate estrogen use Female participants already taking oral estrogen preparations containing greater then 30mcg estradiol Post-menopausal or pre-menarche female participants Female participants whose psychotic illness meets DSM-IV for substance-induced psychotic disorder Female participants who have a current diagnosis of Schizoaffective Disorder and are in a manic phase
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Diabetes Patients for this study will be recruited from the Ralph H. Johnson VAMC in Charleston, South Carolina American veterans aged 18 years and older with Type 2 Diabetes will be recruited Children will not be included as this study pertains to type 2 diabetes, which is not a disease of children Non-English speaking patients are excluded to eliminate bias in the response to questionnaires because these questionnaires have only been validated in English speaking patients We decided to cognitively impaired individuals because of the complexity of the survey instruments
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Estrogen Receptor Positive HER2 Positive Breast Carcinoma HER2/Neu Negative Progesterone Receptor Positive Recurrent Breast Carcinoma Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Histologic, pathologic or cytologic diagnosis of cancer of the female breast in either primary or metastatic setting; histological documentation of metastatic/recurrent disease is not required if there is unequivocal clinical evidence for recurrence Stage IV breast cancer (using American Joint Committee on Cancer [AJCC] 6th edition), or locally advanced (stage III) breast cancer not considered amenable to curative therapy Patients with symptomatic brain metastases or other symptomatic central nervous system (CNS) metastases are not eligible for the study; no screening studies are required among asymptomatic patients; patients with previously treated brain metastases, who are free of symptoms referable to CNS disease and who are > 3 months from treatment for brain metastases are eligible Tumors (as determined on pathology from either primary or metastatic sites) must be potentially sensitive to endocrine therapy, defined as expressing estrogen receptor (ER) and/or progesterone receptor (PgR) as determined immunohistochemical methods according to the local institution's standard protocol, >= 1% cells will be considered to be positive The protocol has been amended to permit tumors with any HER2 status, though a determination of HER2 status must have been made; patients will be considered to be eligible if HER2 expression is documented by one of the following methods Immunohistochemistry (IHC) 0 (i.e., negative), 1+, 2+, or 3+ levels of expression, or Gene amplification (fluorescent in situ hybridization [FISH]) positive or negative Patients must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan Exception: Patients with lytic or blastic bone metastases as their only site of disease will be eligible for the study even though these patients are not considered to have measurable disease by Response Evaluation in Solid Tumors (RECIST) criteria; these patients will be evaluable for time to progression, but not response Patients with all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions including those listed below are not eligible
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Estrogen Receptor-positive Breast Cancer HER2-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected; (this regimen is not intended for neoadjuvant treatment) + nodes OR if 1-3 + nodes, either ER OR HER-2/neu+ OR have high-risk node negative disease that is HER-2/neu positive OR >= 2.0 cm tumor size HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have an echocardiogram or MUGA scan prior to enrollment; the LVEF must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration WBC >= 4,000 ANC >= 1,500 Platelet count >= 100,000 Serum creatinine =< 1.5 x IULN Except for the following, no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situcervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible; this includes Angina pectoris that requires the use of antianginal medication Cardiac arrhythmia requiring medication Severe conduction abnormality Clinically significant valvular disease Cardiomegaly on chest x-ray Ventricular hypertrophy on EKG Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg) Current use of digitalis or beta blockers for CHF
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Any outpatient at a participating Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN) practice within the past 3 years No patient who the Massachusetts General Hospital system lists as having a primary care provider who is not in one of the MGPC-PBRN networks (linking patients with a provider or practice) No patient who is not linked to specific provider or practice (randomized portion of study) Billing, scheduling, and clinical electronic data sources required No mammogram within the past 2 years (randomized portion of study) Hormone receptor status not specified Age 42 to 69 years (randomized portion of study) Female Menopausal status not specified PRIOR No prior bilateral mastectomy (randomized portion of study)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-65.0, Breast, Neoplasms for participation in the study are women, ages 40-65 years of age, who are undergoing a radiologically-guided biopsy (stereotactic ultrasound-guided). We will NOT subjects for current or past use of exogenous hormones; prior hysterectomy or salpingoophorectomy or presentation with a breast mass. Although most biopsies are prompted by a radiologic finding (typically abnormal calcifications or masses), some biopsies are performed for symptoms that are unassociated with a radiologic finding, such as nipple discharge, palpable mass, discomfort, etc. Elevated density per se is not a biopsy indication. ALL women referred for radiologically guided biopsy, irrespective of the indication, will be considered eligible for the pilot study We will women who have a prior history of breast cancer, have had an breast biopsy within one year, women who have implants in place, women taking tamoxifen or raloxifene for chemoprevention and women who have received non-surgical treatments for cancers of other organs
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-54.0, Oophorectomy for Benign Reasons Hysterectomy years of age and older with a benign condition for which subject has decided to have a hysterectomy (removal of the uterus), performed through an abdominal incision (open procedure) or through a laparoscope (minimally invasive procedure). The hysterectomy can be performed with or without removal of the tubes, ovaries or cervix a benign cyst on the ovary(s) which subject has decided to have removed, with or without removal of the entire ovary. The surgery will be done with either an abdominal incision (open) or through a laparoscope (minimally invasive procedure) positive test for the BRCA 1 or 2 gene, which puts subject at an increased risk for breast cancer, and subject has decided to undergo surgery (either with an abdominal incision or through a laparoscope) to remove the uterus, tubes and ovaries, or any combination diagnosis of ovarian cancer or possible ovarian cancer and subject has been advised to undergo a hysterectomy (removal of the uterus), removal of the tubes and ovaries or any combination, with an abdominal incision or through a laparoscope Evidence on gross examination of the surgically removed uterus that there is a carcinoma invading the myometrium; however, post-operative diagnosis of early endometrial carcinoma will not be a cause for post-hoc after specimen and data collection. We will women with a previous gynecologic or gastrointestinal cancer. At the discretion of the surgeon, we will women with cancer in whom the study procedures may interfere with clinical management (e.g. staging of the cancer). We will women who had neo-adjuvant chemotherapy and women who underwent chemoprevention of ovarian or breast cancer. We will also women currently wearing an intrauterine device
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed invasive, hormone receptor-positive (ER and/or PR positive) breast cancer Stage I-III breast cancer including any primary tumor ≥ 1 cm by ultrasound Diagnosis by core needle biopsy with placement of metallic clip at tumor site Sentinel lymph node biopsy (US-guided FNA may be substituted if palpable axillary lymphadenopathy) Evaluation by a surgeon to determine for breast conservation Postmenopausal status (age ≥ 60 yo; or < 60 yo and FSH and estradiol in the postmenopausal range, prior bilateral oophorectomy) Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance > 50 mL/minute (calculated by Cockcroft-Gault formula.) Serum bilirubin < 1.5 x ULN Serum potassium ≥ 4 mmol/L (supplementation allowed) Serum calcium or magnesium within normal range (supplementation allowed) Inflammatory breast cancer Metastatic breast cancer excluding disease in regional lymph nodes Inoperable disease considered irreversible with neoadjuvant endocrine therapy HER2-overexpressed breast cancer Prior chemotherapy or radiotherapy for the treatment of the current breast cancer Prior hormonal therapy for the treatment of the current breast cancer Prior surgical biopsy, lumpectomy, mastectomy for the current breast cancer Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol Currently active diarrhea that may affect the ability of the patient to absorb ZD6474 or tolerate diarrhea Clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease >2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Breast Cancer A woman will be eligible for in this study if she meets all of the following Age >18 to <70 years old Has known ER and PR status Has HER2 nonamplified disease, confirmed by FISH Has known menopausal status (see Section 7.3 for criteria) Has operable, histologically confirmed, Stage I, IIA, IIB, or IIIA, IIIB, or IIIC invasive carcinoma of the breast. Bilateral synchronous breast cancer is allowable provided that 1 primary meets the criteria Meets 1 of the 3 following T1-3N1-3M0 if ER positive or negative T2-3N0M0 if ER positive or negative T1N0M0 if ER and PR negative A woman will be excluded from this study if she meets any of the following Has any evidence of metastatic disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes) Has Stage IV breast cancer (M1 disease on TNM staging system) Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Has had neoadjuvant chemotherapy for this breast cancer Has ever had a myocardial infarction (MI) or has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone replacement therapy), or radiation therapy. Must discontinue prior to registering on the study Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days Has peripheral neuropathy >Grade 1
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically or cytologically confirmed invasive breast carcinoma Early stage breast cancer stage I (tumor size greater than 1 cm), II and IIA HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study ECOG performance status 0 to 2 within 14 days of study entry Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography Must be 18 years of age or older Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential Final for a clinical trial is determined by the health professionals conducting the trial Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone Medical, psychological, or surgical condition which the investigator feels might compromise study participation Pregnant or lactating women are not eligible Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible Evidence of sensory and/or peripheral neuropathy Serious, uncontrolled, concurrent infections Major surgery within 4 weeks of the start of study treatment without complete recovery Final for a clinical trial is determined by the health professionals conducting the trial
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Invasive Breast Cancer Patients must be female and 18 years of age or older Patients must have a clinical T1, T2, or T3 tumor size Patients must have a histopathologic tissue diagnosis of breast cancer by a core-type of breast biopsy Patients must have had biopsy-proven involvement of the axillary lymph nodes at initial presentation based on fine needle aspiration (FNA) cytology, core/Tru-cut biopsy, or pre-treatment SLN biopsy that will require an axillary lymph node dissection to be performed at the time of the definitive breast cancer surgery Patients will have had to undergone preoperative neoadjuvant systemic chemotherapy Patients may be candidates for either lumpectomy or mastectomy Patients may have a history of a previously treated metachronous contralateral breast cancer in the past Patients may have synchronous bilateral breast cancer Patients must not be pregnant (The absence of pregnancy must be documented by any one of the following: negative serum pregnancy test, the history of surgical sterilization, or the absence of menstruation for at least six months prior to enrollment in the study) Patients may not have a history of previous treated ipsilateral breast cancer in the past
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Schizophrenia Schizoaffective Disorder Bipolar Disorder Obesity Metabolic Syndrome Age 18-65; 2. DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; 3. Patients who, in the clinical judgment of the investigator, may benefit from a switch to olanzapine; 4. Females must be of non-child bearing potential (i.e., surgically sterilized, or at least one year post-menopausal) or on an appropriate dose of oral/depot contraceptives or using barrier protection and not breast-feeding. Females must have a urine pregnancy test at screening; 5. Willingness and ability to take medications nightly at 10:00 p.m.; and 6. The subject or his/her legal representative must provide informed, written consent Females who are pregnant or lactating; 2. Concurrent participation or participation within the prior 30 days in any study involving investigational medications; 3. Current (within the prior 30 days) diagnosis of substance abuse or dependence; 4. Use of olanzapine within the prior three months; 5. History of allergy or intolerable side-effects to olanzapine in the past; 6. History of significant head trauma, defined as head trauma resulting in loss of consciousness for more than five minutes and/or neurological or cognitive sequelae; 7. Evidence of any clinically relevant disease (e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, or cancer) or any clinical finding that in the opinion of the investigator could potentially be negatively affected by study participation or that could potentially affect study participation is criterion for from the study; 8. Use of fluvoxamine, nifedipine, or warfarin for 30 days prior to Baseline Visit
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed breast cancer, including the following histologic subtypes Invasive ductal carcinoma Medullary ductal carcinoma Papillary ductal carcinoma Colloid (mucinous) ductal carcinoma Tubular ductal carcinoma The following histologic subtypes are not allowed Invasive lobular carcinoma Extensive lobular carcinoma in situ Ductal carcinoma in situ (DCIS)
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer All patients who present to M. D. Anderson for a stereotactic guided 9 gauge vacuum-assisted breast biopsy and undergo stereotactic biopsy with biopsy clip deployment would be considered for the study If patient refuses biopsy or the biopsy is cancelled they will not be eligible No biopsy clip is seen on the immediate postprocedure mammogram and no additional clip will be deployed Pregnant women are excluded from the study Patients who have had a previous biopsy or surgery in the same (ipsilateral) breast are excluded from the study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-60.0, Breast Cancer Meets 1 of the following Current or prior diagnosis of lobular carcinoma in situ (LCIS) of the breast, including any of the following cases Pure LCIS LCIS with subsequent development of invasive breast cancer of any morphological subtype LCIS presenting as an incidental finding together with invasive breast cancer of any morphological subtype Control participant matched for age and ethnicity to each LCIS patient Not affected by LCIS No history of ductal carcinoma in situ of the breast No breast cancer No relative (up to 2nd degree) who has been affected by breast cancer
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-75.0, Breast Cancer Women with Estrogen Receptor (ER), Progesterone Receptor (PR),and HER2 negative invasive breast cancer confirmed on core biopsy.(Note: HER2 negative by FISH preferred; HER2 0 or 1+ by IHC acceptable) Primary tumor size 2cm or greater by physical exam or radiographic measurements.(Note: Locally advanced T4 or inflammatory breast cancer is eligible.) Assessment of pre-treatment axillary lymph nodal status (Note: FNA biopsy if palpable or sentinel lymph node biopsy (SLNB) if not palpable preferred; clinical exam acceptable.) Absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3 Normal myocardial left ventricular function Serum creatinine < 2.0 mg/dl Total bilirubin and AST < 3X upper limits normal Recurrent or metastatic breast cancer findings (Note: If oncologically felt to be a second breast primary, patient eligible for this protocol) Another active cancer present Medical contraindications to chemotherapy or surgery First trimester pregnancy Breast feeding
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Carcinoma of the Breast Histologically confirmed invasive carcinoma of the breast Tumors must be less than or equal to 3cm in greatest dimension Must have node-negative breast cancer according to teh AJCC 7th edition ER/PR determination is required. ER and PR-assays should be performed by immunohistochemical methods HER-2 positive: IHC 3+ or FISH >2 Bilateral breast cancers that individually meet are allowed Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides must be sent to DFCI for testing Less than or equal to 84 days from mastectomy or from axillary dissection or sentinel node biopsy if the patient's most extensive breast surgery was a breast-sparing procedure All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection Pregnant or nursing women Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes History of prior chemotherapy in past 5 years History of prior trastuzumab therapy Active, unresolved infection Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent Sensitivity to benzyl alcohol Grade 2 or greater neuropathy per NCI's CTCAv3.0. (Exception: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair) Active cardiac disease as outlined in protocol
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Metastatic Breast Cancer Postmenopausal women defined as: aged >/= 50 years with amenorrhea for at least 12 months or aged < 50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (> 40 mIU/ml) or having undergone bilateral oophorectomy Histologically or cytologically confirmed breast cancer Metastatic breast cancer (Stage IV according to UICC Union Internationale Contre Cancer Version 6) Progesterone receptor-positive tumors Patients must be considered candidates for endocrine therapy (no other therapies for breast cancer are required) Disease progression after first-line endocrine therapy for advanced breast cancer (i.e. with tumor remission or stabilization lasting at least 3 months under endocrine therapy) At least one measurable or non-measurable tumor lesion (according to criteria) WHO Performance status 1 Presence of any of the following conditions life-threatening metastatic visceral disease (extensive hepatic involvement) any metastases to the central nervous system (CNS) pulmonary lymphangitic metastases involving more than 50% of the lung More than one prior endocrine treatment for advanced breast cancer Previous combination of endocrine treatment with any other type of treatment (except chemotherapy), or previous sequential endocrine treatments (if there was disease progression between treatments) are not permitted in this trial Patients with breast cancer HER-2 positive or with unknown HER-2 status are not eligible Malignancies or history of prior malignancy other than carcinoma in situ of the cervix or uterus, or basal and squamous cell carcinoma of the skin Intake of CYP3A4 inhibitors less than 2 weeks before start of study treatment A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 65.0-999.0, Breast Cancer Histologically confirmed stage I breast cancer Size ≤ 20 mm (by ultrasound), N0, any quadrant Hormone receptor status not specified Distant metastases Inflammatory breast cancer Lobular in situ disease Invasive cancer or ductal carcinoma in situ Nonepithelial disease or sarcoma Multicentric disease Lymphatic embolism Margins of safety unknown or positive (in situ or invasive) Preoperative mammography showing diffuse microcalcification Female
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Patients with biopsy-proven DCIS, mammographic and CE-MRI evidence of DCIS measuring great then equal to 4cm, and a desire to receive breast conserving therapy, will be considered for participation in this study Patient history, physical examination findings, and demographics (sex, age, height, weight, bra size, etc.) will be performed and documented. for Initial Registration (all patients cohorts): All cohorts Signed informed consent and HIPAA documents Female sex Age great then equal to 40 years Localized ductal carcinoma in situ Clinically and/or histologically negative axillary lymph nodes No imaging or clinical findings suggestive of invasive carcinoma. Cohort 1 (Immediate IORT group) Localized DCIS measuring less then equal to 4 cm on preoperative imaging Cohort 2 (Delayed IORT group) Male sex Age less than 40 DCIS associated with any evidence of microinvasion or invasive carcinoma on pre-operative imaging or core biopsy of the breast or axillary nodes DCIS that is multicentric in the ipsilateral breast. Multicentricity will be defined at 2 or more lesions separated by more than 3 cm in the same breast Non-epithelial breast malignancies such as sarcoma or lymphoma DCIS associated with diffuse suspicious or indeterminate microcalcifications Pregnancy or lactation Collagen vascular diseases, including Systemic lupus erythematosus, Systemic sclerosis (scleroderma), CREST Syndrome (calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, telangiectasia, and the presence of anticentromere antibodies), polymyositis, dermatomyositis with a CPK level above normal or with an active skin rash, inclusion-body myositis, or amyloidosis Serious psychiatric or addictive disorders
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Cancer of the Breast Female, 18-100 years old Not pregnant or breastfeeding Pre-study radiologic documentation of size ≤ 5 cm unicentric, unilateral suspicious mass or calcification classification ≥ IV location of abnormality > 1 cm from skin Ductal or Infiltrating Ductal Carcinoma Grade I-III on final pathology Patient < 18 y/o or > 100 y/o Pregnant or breastfeeding Male Breast implants Multicentric disease or bilateral disease Lesions > 5 cm in diameter Lesions < 1.0 cm from the skin Previous prior radiation to the breast Need for mastectomy Diffuse microcalcifications (as determined by the Investigator)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-90.0, Breast Cancer Female, 18 to 90 years of age Non-pregnant, not breastfeeding Pre-study documentation of Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration Uni-centricity, unilateral cancer by radiology (mammogram and MRI) Location of abnormality > 1 cm from the skin Ductal Carcinoma, Invasive (Grade I-III) or In-Situ No palpable axillary or supraclavicular lymph nodes Good general health Zubrod Performance Status of 0, 1, or 2 Subjects less than 18 years of age or greater than 90 years of age Pregnant or breastfeeding Male Prior Breast Biopsy affected breast Breast implants Multicentric disease, bilateral disease Residual disease after IVEB of > 1cm on MRI Lesions > 1.5 cm in diameter Lesions < 1 cm from skin surface Previous radiation therapy to the breast
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer All tumors must be ER-, PR and HER2-negative Clinical stage T2 or T3, N0-3, M0. Subjects with inflammatory breast cancer are not eligible For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes years of age or older Performance status (PS) of 0 or 1 Use of an effective means of contraception in subjects of child-bearing potential Normal organ function as described in the protocol Any prior cytotoxic chemotherapy or radiation for the current breast cancer HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer Life expectancy of less than 12 weeks Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study Renal dysfunction for which exposure to cisplatin would require dose modifications Steroid dependent asthma Peripheral neuropathy of any etiology that exceeds grade 1 Uncontrolled diabetes History of malignancy treated without curative intent Any other pre-existing medical condition that would represent toxicity in excess of grade 1
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-999.0, Breast Cancer Patient with unifocal histologically proven breast cancer, with or without calcifications in mammogram DCIS (Ductal carcinoma in situ) (Tis, Stage 0) Non-lobular infiltrating carcinoma, maximum of 2 cm in diameter. (T1, Stage I) The patient was operated on and the tumor was excised with lumpectomy The tumor is reported with negative margins >3 mm, as per our hospital protocol For invasive carcinoma, axillary lymph nodes are negative by sentinel lymph node (SLN) mapping and biopsy or by formal axillary lymph node dissection The patient is over 40 years old with life expectancy of at least 5 years Karnofsky status must be at least 70. See appendix I Pre and post-menopausal women are eligible for entry No concurrent or neoadjuvant chemotherapy is allowed. Patient is permitted to be treated with chemotherapy or hormone therapy only after completion of the radiation treatment Patients with diffuse calcifications, multifocal or multicentric disease, lymph-vascular invasion are excluded Patients cannot participate if there is extensive LCIS (Lobular carcinoma in situ) in specimen or extensive DCIS Patients are excluded if systemic disease is present or the patient has been irradiated to the ipsilateral breast or the chest wall Patients who are carriers of BRCA 1/2 mutations or at high risk for hereditary breast cancer due to strong family history (more than one pre-menopausal family member with breast cancer or any ovarian cancer) are excluded because of the increased potential for in-breast recurrence elsewhere in the breast in the absence of whole breast radiotherapy Patients with scleroderma, or systemic or discoid lupus are excluded due to the potential for significant radiotherapy associated toxicity Pregnant woman cannot participate in the study Patients who have serious medical problems which would limit survival to <5 years or a psychiatric condition which would prevent informed consent cannot participate Patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded Patients that have mammographically occult disease are excluded
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer AJCC stage 0, I, or II (TisN0, T1N0, T2N0 = 3 cm) histologically confirmed carcinoma of the breast, treated with tylectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate Signed study-specific informed consent for participation in the study Negative, or close but negative, inked histologic margins of tylectomy or reexcision specimen to be confirmed prior to placing the brachytherapy catheters. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge Negative post-tylectomy or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy For patients with invasive cancer, no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node Invasive ductal, lobular, medullary, papillary, colloid (mucinous),or tubular histologies. Noninvasive ductal carcinoma in situ Chemotherapy or hormonal therapy planned for = 2 weeks after removal of brachytherapy catheters is permitted. Hormonal therapy is allowed during brachytherapy at treating radiation oncologist's decision Negative pregnancy test for premenopausal patients with an intact uterus Patients with distant metastases Patients with in-situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma Patients with proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy Patients who are pregnant or lactating Patients with histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy Patients with systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash Patients with coexisting medical conditions in whom life expectancy is < 2 years Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or completing the full series of high dose rate brachytherapy treatments on an outpatient basis Patients with Paget's disease of the nipple
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-120.0, Breast Cancer Long-term Effects Secondary to Cancer Therapy in Adults Skin Reactions Secondary to Radiation Therapy Women who have chosen to undergo breast conservation therapy, including lumpectomy and breast irradiation, at the University of Pennsylvania for any invasive mammary carcinoma or intraductal breast cancer Stage I-II invasive or intraductal breast cancer Unifocal tumor ≤ 3.0 cm in size Patients with microscopic multifocality are eligible provided total pathologic tumor size is ≤ 3 cm No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters Pre or post-biopsy ipsilateral* breast MRI negative for multicentric disease (i.e., areas of cancer that cannot be removed in a single excision specimen) or other suspicious findings NOTE: *Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields. Both sides may be treated with partial breast irradiation (PBI) if the pathologic are met for both tumors, or only one side may be treated with PBI if the are met for only one tumor Negative margins of excision (≥ 2 mm) OR no tumor seen in a re-excision specimen No extensive intraductal component present Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed)
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-999.0, Breast Cancer Histologically confirmed primary invasive breast carcinoma Stage I-IIA disease (T1, N0, M0 or T2, N0, M0) Pathologically determined single, discrete, and well-defined primary tumor ≤ 5 cm in diameter Pathologically negative surgical margins No multicentric disease and/or diffuse malignant appearing microcalcifications Micro-calcifications must be focal Specimen radiograph is required after lumpectomy for tumors associated with malignant appearing calcifications to assure removal of all malignant appearing calcifications Specimen radiograph is optional if the tumor appears as a discrete mass on mammogram No axillary lymph node involvement No evidence of metastatic breast cancer
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Biopsy-confirmed invasive ductal carcinoma of the breast Unifocal disease as defined by clinical examination, mammography, and ultrasound Patient must be proceeding to mastectomy Hormone receptor status unknown No T4d or multifocal disease (as defined on conventional imaging) Index tumor ≤ 4 cm in diameter Menopausal status not specified Female No claustrophobia No cup size of DD or greater PRIOR
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 25.0-999.0, Breast Cancer Individuals aged 25 years or older Individuals who have at least one breast imaging finding requiring biopsy, specifically Individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or MRI (as per ACR 4C or 5) and requiring biopsy confirmation OR o Individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution FDG PET scan Individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest Individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or MRI if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or MRI if not detectable on mammography) is more than 1 cm. (Note: The study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, CT, or MRI, if the lesion is not detectable or measurable on mammography.) Individuals who have agreed to participate in the study and who have signed study-specific informed consent Women who are or may be pregnant Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study Age less than 25 years Individuals with breast implant(s) in the breast containing the lesion of interest Individuals who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PET-guided biopsy Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure Individuals with Type I or poorly controlled Type II diabetes mellitus Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging Inability to provide informed consent Individuals who have had surgery on the study breast(s) within the past 12 months
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-120.0, Breast Cancer Participant in the Mayo Mammography Health Study Has consented to provide baseline mammogram for digitization ECOG performance status 0-1 Female Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months) Able to give informed consent and complete food records alone or with assistance Willing to provide research blood and urine samples Must be a non-smoker Willing to maintain current weight No history of breast ductal carcinoma in situ or any other cancer, except basal cell or squamous cell skin cancer or lobular carcinoma in situ
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 50.0-999.0, Breast Neoplasms The patient must consent to be in the study and must have a signed an approved consent form conforming with institutional guidelines Patient must be > 50 years old The patient should have a life expectancy of at least two years The patient must have stage 0 , I , or II breast cancer. If stage IIA, the tumor size must be 3 cm or less and the patients must be node negative On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.) Patients with invasive breast cancer are required to have axillary staging which can sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is NOT required for patients with DCIS.) The patient must have the MammoSite catheter placed within 4 weeks or 28 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). Placement of a spacer for the MammoSite catheter is permitted at their final surgery Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible Men are not eligible for this study T2 (>3.0 cm), T3, node positive, stage III or IV breast cancer Any positive axillary nodes Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign Non-epithelial breast malignancies such as sarcoma or lymphoma Proven multicentric carcinoma in more than one quadrant or separated by more than 3 centimeters Paget's disease of the nipple History of invasive breast cancer or DCIS in the same breast Surgical margins that cannot be microscopically assessed or are less then 2 mm
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-75.0, Breast Cancer Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed Tumor involvement of at least one axillary lymph node (N0 with HER2/c-neu over expression are also eligible) Absence of any clinical or radiological evidence of local or metastatic disease Premenopausal or postmenopausal women aged 18-75 years old Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3) Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl) Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease Written informed consent Positive pregnancy test Psychiatric illness or social situation that would preclude study compliance Other concurrent uncontrolled illness Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents Previous history of other invasive malignancy other than non-melanomatous skin cancer
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-90.0, Breast Cancer HER2-negative Breast Cancer HER2-positive Breast Cancer Recurrent Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 1 cm and or lymph node positive Physical examination, and scans needed for tumor assessment must be performed within 90 days prior to registration Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible Serum creatinine within normal limits within 90 days prior to registration Bilirubin within normal limits within 90 days prior to registration Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 2 x the institutional upper limit of normal within 90 days prior to registration Absolute neutrophil count (ANC) of >= 1,500/microliters within 90 days prior to registration Platelet count of >= 100,000/microliters within 90 days prior to registration Patients must have a performance status of 0-2 by Zubrod Pregnant or nursing women may not participate; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnancy test required for women of childbearing potential
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Atypical Lobular Hyperplasia Atypical Ductal Hyperplasia Lobular Carcinoma in Situ for Surveillance Arm Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist. for Diagnostic Arm Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist They are unable to understand and sign the consent form They are pregnant or lactating They are physically unable to sit upright and still for 40 minutes They are younger than 18 years of age
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically proven invasive unilateral breast cancer (regardless of the type) Initial clinical condition compatible with complete initial resection No residual macro or microscopic tumor after surgical excision Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following Stage II or III disease pT >20 mm (T1-4) Patients must meet 1 of the following hormone-receptor Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+) Node-negative patients: triple-negative* tumor only NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative Clinically or radiologically detectable metastases (M0) Bilateral breast cancer or contralateral ductal carcinoma in situ Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type Any tumor ≥T4a (cutaneous invasion, deep adherence, inflammatory breast cancer) HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive Any clinically or radiologically suspect and non-explored damage to the contralateral breast Female Pre or postmenopausal ECOG performance status 0-1
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1
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Male and Female patients Aged 18 or older at the time of breast cancer diagnosis Patients with invasive breast cancer at least 1 cm in size. Patients who have had a prior surgical excision are eligible provided there is a residual of at least a 1 cm area suspected on imaging studies Histopathologic review at MSKCC confirming diagnosis of invasive breast cancer (ductal, lobular, or inflammatory breast cancer) Patients who are operative candidates. Patient will have surgery to either mastectomy or lumpectomy. Radiologic assisted excisions such as needle localization are also eligible Patients with bilateral breast cancer are eligible Patients with metastatic cancer, provided they need surgical biopsy Patients who are undergoing sentinel node mapping (day before or sameday mapping) Patient must sign informed consent Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer) Patients who are pregnant or nursing Patients unable to tolerate PET or PET/CT Patients with known active infection, autoimmune or inflammatory disease such as sarcoidosis, and rheumatoid arthritis Patients with non invasive breast cancer such as DCIS Patients who have received prior radiation therapy to the affected breast Patients who have received prior chemotherapy, including neoadjuvant chemotherapy or hormonal therapy for breast cancer Patients living in a residential care or correctional facility
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Ductal Breast Cancer Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT years of age or older ECOG Performance Status 0 Required laboratory data as outlined in the protocol Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region Tumor > 2.0cm, nodal involvement, or metastatic involvement Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma Known mutation carrier, including BRCA1 and BRCA2 History of cosmetic or reconstructive breast surgery Psychiatric illness which would prevent the patient from giving informed consent Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease Participants with a "currently active" second malignancy other than non-melanoma skin cancers Patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Infiltrative Breast Cancer Women> or = 18 years old Women with newly diagnosis of infiltrative breast cancer Agree to take part in this study Women with other malignant tumor (except in situ cervical carcinoma or treated basal cell carcinoma) Women with in situ ductal carcinoma or in situ lobular carcinoma
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-999.0, Breast Cancer Axillary Lymph Node Dissection Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND Females > 21 years of age Prior ipsilateral axillary surgery Prior ipsilateral axillary radiation Prior ipsilateral breast cancer Prior ipsilateral breast radiation Allergy to isosulfan blue dye History of ipsilateral upper extremity lymphedema Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast Prior history of neoadjuvant chemotherapy for current breast cancer Bulky axillary disease at presentation (N2)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Imaged Breast Abnormalities Patient must be a female at least 18 years of age at the time of Intact BLES biopsy Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis Patients who have pre-pectoral breast implants Patients who have implantable devices such as pacemakers and defibrillators Patients who are pregnant or lactating Patients in whom the device is contraindicated Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Breast Abnormalities Female subjects who have breast masses and scheduled for core biopsy Pregnant or lactating females Females who have heart problems or sensitivity to contrast agents Females who have had previous surgery for breast cancer
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. 2. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer. Note: Prior rotational and/or vacuum-assisted core biopsies are permitted if no significant distortion is seen on imaging that could obscure visualization and detection of residual disease on MRI, or visualization of cancer on ultrasound for cryoablation procedure. 3. Tumor size ≤ 2.0 cm in greatest diameter. Specifically, the tumor must measure ≤ 2.0 cm in the axis parallel to the treatment probe and ≤ 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility. 4. Tumor enhancement on pre-study MRI. 5. Tumor with < 25% intraductal components in the aggregate. NOTE: The percent intraductal component from the patient's diagnostic biopsy must be available prior to registration. If the biopsy pathology report does not contain the percent intraductal component, then re-review of pathology slides and creation of a report addendum or note-to-file by the reviewing pathologist will be required. 6. No prior or planned neoadjuvant chemotherapy for breast cancer. 7. Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential. 8. Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. NOTE: For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant. 9. Patients with prior in-situ or invasive breast carcinomas are eligible if the prior carcinomas occurred in the contralateral breast. Patients with prior in-situ or invasive carcinomas of the ipsilateral breast are not eligible
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-120.0, Breast Cancer Menopausal Symptoms Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 6 months Absolute Neutrophil Count (ANC) ≥ 1.0 x 10^9/L Platelet count ≥ 100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times Upper Limit of Normal (ULN) Total bilirubin ≤ 2.5 times ULN Creatinine clearance ≥ 50 mL/min Fertile patients must use effective contraception PRIOR No limitations to number of prior therapies No limitations for prior radiotherapy More than 14 days since prior and no other concurrent investigational agent Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin No concurrent medications known to inhibit CYP2D6, including any of the following Amiodarone Haloperidol Indinavir Ritonavir Quinidine No concurrent selective serotonin reuptake inhibitors, except the following
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Ductal Carcinoma In Situ The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines for the study treatment and for the pre-entry tumor block submission for HER2 testing and B-43 correlative studies Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory) On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) (patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible) The DCIS must be HER2-positive as determined by central testing Estrogen and/or progesterone receptor status must be determined prior to randomization (patients with DCIS that is hormone receptor positive or negative are eligible) All DCIS must have been resected by lumpectomy The margins of the resected specimen must be histologically free of DCIS; for patients in whom pathologic examination demonstrates DCIS present at the line of resection, re-excision(s) may be performed to obtain clear margins (patients who require mastectomy are not eligible) If axillary staging is performed, nodal staging must be pN0, pN0(i-), pN0(i+) which is defined as isolated tumor cells =< 0.2 mm, regardless of the method of detection, i.e., immunohistochemistry (IHC) or hematoxylin & eosin (H&E), pN0(mol-), or pN0(mol+); note: axillary staging is not required The interval between the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins) and randomization must be no more than 120 days Invasive (including microinvasion staged as T1mic) breast cancer (patients with DCIS "suspicious" for microinvasion, but not confirmed, are eligible) Nodal staging of pN1 (including pN1mi) (note: axillary staging is not required) DCIS present in more than one quadrant (multicentric) Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign (if DCIS is found, the patient is eligible if the DCIS was in the same quadrant of the ipsilateral breast and was resected with clear margins) Contralateral breast cancer (including DCIS) Whole breast irradiation administered before randomization (partial breast irradiation is prohibited) Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible) Prior anthracycline chemotherapy for any malignancy Cardiac disease that would preclude the use of the drugs included in the B-43 treatment regimens; this includes but is not confined to Active cardiac disease
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Pelvic Inflammatory Disease women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Female patients greater than or equal to18 years of age. 2. Histologically confirmed invasive unilateral breast cancer (regardless of histology). 3. Early-stage breast cancer, defined as Node-positive disease: >0.2-mm metastasis in at least one lymph node (pN1mipN2b)OR Node-negative, with primary tumor >1.0 cm (T1c-T3). 4. Definitive loco-regional surgery must have been completed as specified below Patients must have undergone either breast conservation surgery (i.e., lumpectomy) or total mastectomy Surgical margins of the resected section must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ Surgical margins involved with lobular carcinoma in situ (LCIS) will not be considered as a positive margin; therefore, such patients will be eligible for this study without additional resection Patients must have completed axillary lymph node sampling for the pathologic evaluation of axillary lymph nodes as specified below: Sentinel node biopsy and/or either lymph node sampling procedure or axillary dissection. 5. Multicentric and multifocal invasive breast cancer is eligible if loco-regional surgery has been completed as described above. 6. Patients with synchronous bilateral cancers are eligible only if All cancers are of triple-negative phenotype, defined as ER-, PR-, HER2- based on the highest stage grouping. 7. HER2 negative tumors. HER2 negativity must be confirmed by one of the following FISH-negative (FISH ratio <2.2), or Women who are pregnant or breastfeeding. 2. History of previous diagnosis of invasive breast cancer (unless treated >5 years previously with no recurrence). History of previously treated ductal carcinoma in situ (DCIS) is acceptable. 3. Any evidence or suspicion of metastatic disease other than ipsilateral axillary lymph nodes. 4. Any tumor >=T4 (cutaneous invasion, deep adherence, inflammatory breast cancer). 5. Previous anthracycline chemotherapy. 6. Concurrent use of CYP3A4 inhibitors from 72 hours prior to initiation of study treatment until the end of treatment with ixabepilone. 7. Previous treatment for this breast cancer (including neoadjuvant chemotherapy). 8. Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years (including invasive contralateral breast cancer). 9. Peripheral neuropathy of > grade 1 per NCI CTCAE v3.0. 10. Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. 11. History of hypersensitivity to CremophorEL (polyoxyethylated castor oil) or a drug formulated in CremophorEL such as paclitaxel. 12. Use of any investigational agent within 30 days of administration of the first dose of study drug. 13. Patients may not receive any other investigational or anti-cancer treatments while participating in this study. 14. Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. 15. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study. 16. Inability to comply with study and/or follow-up procedures
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-70.0, Thyroid Cancer Age: 18 to 70 Sonographically node-negative cytology confirmed thyroid papillary carcinoma Tumor size less than 1 cm in sonography Tumor confined to the one lobe of the thyroid gland One who provides the informed consent History of radiation treatment to head and neck area History of other malignancy except thyroid cancer Poor performance status (ECOG 3-4)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-65.0, Breast Cancer Primary carcinoma of the breast, confirmed histologically by core biopsy (at least 3 core biopsy samples) 2. Tumor lesion of the breast with a palpable or a imagistic size ≥ 2 cm or inflammatory breast cancer 3. Known HER-2 status detected on core biopsy. HER-2 over expression is defined as DAKO HercepTest (3+) or DAKO HercepTest (2+) and FISH (+) (fluorescence-in-situ-hybridisation). 4. No distant metastatic disease, confirmed by chest x-ray, abdominal sonography and bone scan. 5. Female patients 6. Age ≥ 18 and ≤ 65 years 7. ECOG < 2/WHO 0-1 8. Laboratory requirements GOT and Bilirubin < 1.5x UNL Leukocytes >= 3 G/l Neutrophile > 1 G/l Thrombocytes > 100 G/l Creatinine (Serum) < 2.0 mg/dl. 9. Normal cardiac function, confirmed by cardiologist 10. No active hepatitis 11. Written informed consent for all study procedures 12. Patients must be available and compliant for treatment and follow-up Multicentricity in various quadrants (contact the study office) 2. CNS-metastases 3. Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the cervix that has received curative therapy 4. Patients with relevant hemodynamic cardial diseases 5. Patients with a left ventricular ejection fraction (LVEF) under the normal limit of the institution, confirmed by echocardiography or MUGA-Scan. 6. Uncontrolled, severe comorbidities 7. Patients with severe respiratory diseases and severe dyspnea and / or which need supportive oxygen 8. Previous anti-HER2-therapy 9. Patients receiving immunosuppressant therapy 10. Known allergy to medication containing cremophor 11. Hb <10 g/dL, Neutrophile <1.5 x109/L, Thrombocytes <100 x109/L. 12. Total-Serum-Bilirubin >1.5 x ULN (upper limit of normal) (except in patients with confirmed and documented Gilbert-Lereboullet-syndrome), ALT or AST >2.5 x ULN (>5 x ULN by liver metastases), Alkaline Phosphatase >2.5 x ULN (>4 x ULN by liver or bone metastases), Serumcreatinine > 2 x ULN 13. Pregnancy, nursing (a negative pregnancy test must be documented, and safe anticontraceptive measures during pre and postoperative treatment must be implemented) 14. Lack of signed informed consent after informing the patient 15. Lack of willingness to keep and disclose personal medical data as part of the study
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Pathologically confirmed stage 0, I or II bilateral or unilateral breast cancer Any invasive adenocarcinoma or intraductal carcinoma Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Surgical treatment with lumpectomy (partial mastectomy) Successful placement of intraparenchymal metallic markers at last breast surgery Pathologic tumor size < 5.0 cm (Microscopic multifocality is allowed if total pathologic tumor size is within 5 cm) Axillary sampling (sentinel node or axillary dissection) performed for axillary nodal staging for all invasive cancers. No axillary sampling is required for ductal carcinoma in situ) Negative margins of excision Radiation treatment to begin within 8 weeks after last surgery or last dose of chemotherapy Negative post-biopsy mammogram if presented with mammographically detected microcalcifications to ensure removal of suspicious calcifications Pregnant or breast feeding at time of study entry. Note: Radiation therapy is teratogenic. Women of child bearing potential must agree to use adequate contraception (abstinence, hormonal or barrier method of birth control) prior to and during study participation. Should a woman become pregnant, she should inform the treating physicians immediately Prior in-field irradiation Stage III or IV breast cancer Inability to place intraparenchymal metallic markers due to excessive bleeding or other intraoperative complication so that the surgeon deems it inadvisable to place the marker Pathologic tumor size >/= 5 cm Positive or unassessed margins of surgical resection Diffuse calcifications on mammogram pre or post-operatively Positive or suspicious post-lumpectomy mammogram or breast magnetic resonance imaging (MRI) Multicentric carcinoma in more than one quadrant of the breast
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 20.0-999.0, Myelodysplastic Syndromes Must understand and voluntarily sign an informed consent form Age ≥ 20 years at the time of signing the informed consent form Must be able to adhere to the study visit schedule and other protocol requirements Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) for low or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality Symptomatic anemia secondary to MDS defined as:Untransfused Hb level < 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia Pregnant or lactating females Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study Prior therapy with lenalidomide Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) < 750 cells/μL (0.75 x 10^9/L) Platelet count < 50,000/μL (50x10^9/L) Serum creatinine > 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3.0 x Upper Limit of Normal (ULN)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Postmenopausal Women with primary breast cancer who are candidates for radical surgery Breast tumours clinically ≥ 15 mm, Nx, M0 Breast tumours identified on mammography and verified on fine needle aspiration Age > 18 years Performance status of ECOG ≤ 1 Laboratory requirements at the day of diagnosis (t1-):Prior to a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations Negative pregnancy test for pre menopausal women before in the trial Ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe) Prior breast cancer treatment Current HRT Known liver disease History of hemorrhagic stroke Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Patients with invasive breast cancer are required to have axillary staging which can sentinel node biopsy alone if sentinel node is negative or axillary dissection or sampling with a minimum total of 6 axillary nodes if sentinel node is positive. Axillary staging is not required for patients with DCIS Estrogen receptor (ER) and progesterone receptor (PR) analysis must be negative The patient must be ≥ 18 years old If the patient is older than 49 years, she must meet at least one of the following 2 conditions: i. 1-3 histologically positive axillary nodes ii. negative ER and PR analysis The patient should have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer The tumor must be DCIS or invasive adenocarcinoma of the breast Gross disease must be unifocal with pathologic tumor size 3.0 cm or less. Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3.0 cm or less The patient must have pathological stage 0, I, or II breast cancer Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive). Re-excision of surgical margins is permitted The patient must be registered within 42 days following the last surgery for breast cancer The patient is < 18 years old If the patient is older than 49 years, she has both an ER and PR positive tumor and histologically negative axillary nodes T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer "Marginal" or "borderline" ER or PR analysis results More than 3 histologically positive axillary nodes Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension One or more positive non-axillary sentinel node(s). Intramammary nodes are staged as axillary nodes Non-epithelial breast malignancies such as sarcoma or lymphoma Proven multicentric carcinoma in more than one quadrant or separated by 4 or more centimeters Paget's disease of the nipple
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-90.0, Breast Cancer Have a lesion on mammogram, ultrasound or breast MRI that measured < 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy). OR Have a lesion on mammogram, ultrasound or breast MRI that measured > 15 mm in diameter, is known to be malignant and is scheduled for surgery Patient age > 18 years of age Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized Patients will be excluded if they have a small lesion (< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692) Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test Patient is unable to sit on a chair for 40 minutes
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Meets one of the following Woman with newly diagnosed early-stage breast cancer Caregiver or companion willing to participate in study Speaks native English or has learned to speak English fluently Patient's companion ≥ 18 years old (if applicable) Able to complete questionnaires without assistance Not pregnant PRIOR Not specified
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-120.0, Breast Cancer Agrees to undergo breast surgical procedure AND meets one of the following Scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings Diagnosis of ductal carcinoma in situ (DCIS) or carcinoma in the breast to be studied (opposite breast may also be studied) Hormone receptor status not specified Female Pre or post-menopausal Not currently pregnant or pregnant within the past 12 months Must not have lactated within the past 12 months No active infection or inflammation in the breast to be studied
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Undergoing surgery for breast cancer OR core biopsy sampling of the breast Not specified PRIOR Not specified
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Provision of written informed consent. 2. Patient muse be female. 3. Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following A total mastectomy with institutional standard axillary nodal dissection Lumpectomy or a quadrantectomy with institutional standard axillary dissection with breast radiotherapy (may be deferred until chemotherapy is completed) in accordance with breast preservation Treatment of the breast cancer following diagnosis may have included any of the following; post-lumpectomy/quadrantectomy regional radiotherapy, post-mastectomy locoregional radiotherapy, postoperative chemotherapy, and trastuzumab. 4. The tumor must have been pathologic primary invasive carcinoma by core needle or open biopsy. 5. The beginning of endocrine therapy (letrozole or anastrozole) must be no more than 6 weeks from the end day of chemotherapy or radiotherapy. 6. The date of randomization must be no less than 2 years of letrozole and no more than 3 years letrozole treatment. 7. Positive node is defined as defined as the presence of at least micro metastasis greater than 0.2 mm according to the AJCC Breast Staging Edition 6. 8. Patients who have had neoadjuvant chemotherapy are eligible. Positive lymph node involvement can be defined either prior of neoadjuvant chemotherapy or at the time of surgery following their neoadjuvant therapy. Lymph node positivity would be defined as the following Pre-neoadjuvant chemotherapy lymph node assessment must identification of a histological positive axillary, internal mammary or supraclavicular determined by one of the following: FNA of lymph node or sentinel lymph node evaluation, or complete or limited axillary dissection For patients that have completed their neoadjuvant chemotherapy, without prior documentation of a positive lymph node, lymph node positivity must be demonstrated at the time of their primary surgery as defined by either Either sentinel lymph node or primary axillary dissection identifying a positive lymph node is acceptable as per standard institutional practice guidelines Histological evidence of a N1-N3c lymph node involvement identified at the time of primary breast surgery following neoadjuvant chemotherapy. 9. Presence of occult axillary lymph node with no evidence of primary breast tumor must be confirmed pathologically primary breast invasive carcinoma or DCIS with microinvasive. And the measurement of ER, PR and HER2 must be performed on the initial lymph nodes or breast tumors. 10. Bilateral, synchronous breast cancer is allowed provided at least one of the primary tumors meets the criteria. 11. Hormone receptor-positive tumors, defined as any detectable estrogen or progesterone receptor expression by institutional standards.Patients who are PR positive and ER negative are eligible for the trial. Tumor slides should be submitted for central evaluation of hormone receptor status as per Section. 12. HER2 status must be known, Tumor slides should be submitted for central evaluation of hormone receptor status as per Section. 13. Physical and laboratory examination as per standard institutional practice,should be obtained at the time of definitive surgery to demonstrate there is no evidence of metastatic or recurrent disease. 14. Patients must be postmenopausal at the time of initial diagnosis. For study purposes, postmenopausal is defined as Prior bilateral oophorectomy Age ≥ 60 y Presence of metastatic disease. 2. Previous diagnosis of metachronous bilateral breast cancer. 3. Previous or concomitant other (non-breast cancer) malignance within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell. 4. Presence of other non-malignant disease which may prevent prolonged follow-up. 5. Received neoadjuvant endocrine therapy. 6. Adjuvant SERMs therapy (Tamoxifen or Toremifene) for more than 6 months before randomization. 7. Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer. 8. Severe hepatic dysfunction defined as Child-Pugh grade C. 9. Severe cardiac dysfunction defined above NYHA grade III. 10. Presence of occult axillary lymph node with no evidence of primary breast tumor pathologically or DCIS with microinvasive. And the measurement of ER, PR and HER2 are not obtained. 11. Uncontrolled psychological diseases
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 60.0-999.0, Operable Breast Neoplasms Informed consent Age 60 years or older Measurable non-metastatic and non-inflammatory breast cancer Tumor of 2 cm or larger ER and/or PgR positive tumor Co-morbidity index 0 e.g., no other serious medical condition Prior medical therapy for a malignant disease, including aromatase inhibitors Distant metastasis Need for chemotherapy Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri) Treatment with a non-approved drug within 30 days
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-120.0, Breast Cancer Histologically confirmed breast cancer, including 1 of the following subtypes Ductal carcinoma in situ Invasive ductal carcinoma Invasive lobular carcinoma Medullary carcinoma Papillary carcinoma Colloidal (mucinous) carcinoma Tubular carcinoma Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0) Tumor size ≤ 5 cm
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.0-999.0, Breast Cancer Diagnosis of breast cancer Tissue samples available Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative ER-positive/PR-positive/ HER2-positive by FISH ER-negative/PR-negative/HER2-positive ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers) Menopausal status not specified PRIOR Not specified There are no in this protocol
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2
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically or cytologically confirmed invasive breast cancer. HER2 positive disease is not allowed. Metastatic breast cancer (Stage IV) is not allowed For patients entering the trial after neoadjuvant chemotherapy, there must be the presence of residual invasive disease on pathologic review following neoadjuvant chemotherapy. Residual disease is defined as a Miller-Payne response in the breast of 0-4 and/or residual carcinoma in one or more regional lymph nodes that would meet AJCC 7th edition for N1 N3 disease. The presence of DCIS without invasion does not qualify as residual disease. Alternatively, if Miller-Payne grading is not available, the patient will be eligible if the pathology report indicates any residual invasive carcinoma following neoadjuvant therapy If tumor is triple negative (ER-/PR-/HER2-) and the patient received neoadjuvant chemotherapy, disease may be clinical stage I-III pre-operatively, per AJCC 7th edition, based on baseline evaluation by clinical examination and/or breast imaging. Patients must have the presence of residual invasive disease on pathologic review following their neoadjuvant chemotherapy If tumor is triple negative and the patient did not receive neoadjuvant chemotherapy, there must be pathologic lymph node positivity and Stage IIB or greater disease after surgery. For the purposes of lymph node positivity can refer to either axillary or intramammary lymph nodes If tumor is hormone receptor positive, disease must be clinical Stage III neoadjuvantly, per AJCC 7th edition, based on baseline evaluation by clinical examination and/or breast imaging, or pathologic Stage IIB or greater at time of definitive surgery. Patients with hormone receptor positive breast cancer who do not receive neoadjuvant chemotherapy are not eligible for this protocol For patients who completed neoadjuvant chemotherapy, the regimen must contain an anthracycline, a taxane, or both. Patients who have received neoadjuvant therapy as part of a clinical trial are acceptable. Protocol therapy must be initiated < 180 days after last surgery for breast cancer. For triple negative patients who receive adjuvant chemotherapy only, the regimen must contain both an anthracycline and a taxane. For these patients, protocol therapy must be initiated < 28 weeks after initiation of adjuvant chemotherapy Patients with ER+ and/or PR+ breast cancer should receive adjuvant hormonal therapy No prior exposure to bevacizumab or other inhibitors of angiogenesis is allowed Patients must have completed definitive resection of primary tumor. Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however positive margins are acceptable if the treatment team believes no further surgery is possible and patient has received radiotherapy. Patients with margins positive for lobular carcinoma in situ are eligible Laboratory assessments as outlined in the protocol Stage IV breast cancer. Patients with metastatic disease are ineligible. However, specific staging studies are not required in the absence of symptoms Prior history of hypertensive crisis or hypertensive encephalopathy History if myocardial infarction or unstable angina within 12 months prior to registration History of stroke or transient ischemic attack at any time Significant vascular disease within 6 months prior to registration History of hemoptysis within 1 month prior to registration Ongoing or active infection NYHA Grade II or greater congestive heart failure Unstable angina pectoralis
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Histologically proven adenocarcinoma of the breast No apocrine, adenoidcystic, or squamous carcinomas or sarcomas Pathologic Stage T1-3a, pathologic N1-2 (clinical N0-1), M0: Rendered free of gross tumor at surgery Primary tumor movable with respect to chest wall Axillary nodes movable with respect to chest wall and each other No preoperative edema of the arm, peau d'orange, skin ulceration, or inflammatory lesions One or more positive lymph nodes required No positive deep mastectomy margins or clinical skin involvement (focal microscopic dermal invasion or focal microscopic dermal lymphatic involvement allowed) No evidence of metastatic disease on pretherapy studies (including chest x-ray, bone scan, and mammogram) No bilateral invasive tumors Patients who had noninvasive ductal carcinoma in situ of the opposite breast and underwent prophylactic contralateral mastectomy are eligible Hormone receptor status: Positive for estrogen and/or progesterone receptors (at least 10 fmol/mg protein or unequivocally positive immunocytochemical assay for one or both) Participation in SWOG-8854 (flow cytometry) recommended Age: Any age Sex: Females only Menopausal status: Postmenopausal as defined by 1 or more of the following: Bilateral oophorectomy at least 2 months prior to diagnosis of breast cancer (with or without estrogen therapy following surgery) Prior hysterectomy with at least 1 ovary remaining and either over 60 years old or with a postmenopausal FSH level Natural menopause (last menstrual period at least 1 year prior to registration or 4-12 months prior to registration with a postmenopausal FSH level) Treated with postmenopausal estrogen therapy and either over 55 years old or with a postmenopausal FSH level Performance status: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.2 x normal Alkaline phosphatase no more than 1.2 x normal SGOT or SGPT no more than 1.2 x normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No uncontrolled hypertension No history of ischemic heart disease or CHF Normal ejection fraction by MUGA (required only if deemed clinically necessary for assessment) Other: No medical condition that would preclude protocol therapy: No severe diabetes No active ulcer disease No significant psychiatric disease No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Curatively treated Stage I cervical carcinoma Pretreatment mammogram and chest x-ray completed no more than 3 months preoperatively; blood/body fluid analyses to determine completed within 14 days prior to registration; prestudy bone scan completed within 12 weeks prior to registration and/or within 4 weeks prior to surgery PRIOR Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy (except for up to 14 days of tamoxifen stopped prior to registration) Prior estrogen and/or progesterone-containing hormone preparations for nononcologic therapy allowed, but must be discontinued prior to registration Postmenopausal estrogen therapy should be discontinued in all patients at the time of diagnosis of breast cancer Radiotherapy: Postoperative chest wall and/or regional lymph node irradiation allowed for mastectomy patients (at discretion of the physician) either prior to registration or on protocol for any of the following: Tumor greater than 5 cm in diameter 4 or more positive nodes Extranodal extension of tumor into the axillary fat No radiotherapy for any other reason in mastectomy patients Postoperative radiotherapy either prior to registration, during tamoxifen, or after completion of chemotherapy required for lumpectomy patients Radiotherapy must be completed (if it is to be given before chemotherapy) prior to registration No immediate radiotherapy after randomization to chemotherapy Surgery: Radical, modified radical, or breast-sparing surgical procedure with at least a level I and II axillary dissection and analysis of at least 6 nodes required within 12 weeks prior to registration Lumpectomy must Total excisional biopsy with rim of normal breast tissue Microscopically negative margins Level I and II axillary dissection Tumor no more than 5 cm in greatest diameter Clinical and mammographic examination demonstrating absence of multicentric lesions Type of surgery, number of nodes examined, number of positive nodes, and size of the primary tumor (size of the largest tumor if more than 1 mass) must be recorded
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Have a lesion on Mammogram, Ultrasound or MRI that measured < 2 cm and considered suspicious or suggestive of malignancy Scheduled for biopsy of lesion > 18 years of age Negative pregnancy test, postmenopausal, or surgically sterilized Prior needle biopsy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 40.0-75.0, Breast Carcinoma Age between 40 and 75 years Clinical, mammographic or ultrasonographic diagnosis of a unicentric carcinoma with an ultrasonographic diameter of equal or less than 2.0 cm Although not a factor of a breast scintigraphy using MDP-99m is recommended for accurate determination of possible multifocality or multicentricity of the tumor, as well as for the determination of possible bone metastasis Axillary lymph nodes that cannot be palpated or that are not clinically suspicious for metastasis No previously executed therapy (including biopsy) at any outside institution Those patients with nonpalpable lesions will be subjected to preoperative radioactive occult lesion localization (ROLL) or stereotactic biopsy Adequate patient information and signature of the informed consent Lesions diagnosed as non-infiltrating (in-situ) ductal or lobular carcinoma Paget's disease Documented multicentricity and/or abundant multifocality of the neoplasm Clinically metastatic lymph nodes Patients previously biopsied at other institutions Carcinomas detected during pregnancy or lactation Histotypes diverse from breast carcinoma lesions History of previous malignancy (excluding basocellular carcinoma, in-situ cervical carcinoma and/or contralateral breast carcinoma without recurrence for at least 15 years of follow-up)
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 36.0-95.0, Breast Cancer Operable breast cancer Inoperable breast cancer BMI > 25 Neoadiuvant radioterapy Carcinomastitis Previous phlebitis of omolateral arm Collagen disease
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Newly diagnosed biopsy proven breast cancer for which a lumpectomy or mastectomy is planned Control Selection ER+, HER2-: estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2 -) as defined according to institutional standards Phase I Selection ER+, HER2- ER+, HER2+ ER-, HER2+ ER-, PR+, HER2- ER-, PR-, HER2- Phase II Selection Pregnant or lactating Known positive HIV status or on medications for HIV Diagnosis of diabetes due to potential problems with insulin resistance and hyperglycemia Any pre-existing gastrointestinal complaints including nausea, abdominal pain and/or diarrhea Known hypersensitivity to ritonavir or any of the tablet ingredients Co-administration of ritonavir is contraindicated with any of the drugs - Contraindicated Drugs because competition for primarily CYP3A by ritonavir could result in inhibition of the metabolism of these drugs and create the potential for serious and/or life-threatening reactions such as cardiac arrhythmias, prolonged or increased sedation, and respiratory depression. Voriconazole is an exception in that co-administration of ritonavir and voriconazole results in a significant decrease in plasma concentrations of voriconazole. If the patient cannot discontinue a contraindicated drug, she is not eligible for the trial Incompatible Drugs
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Women who satisfy all of the following conditions are the only patients who will be eligible for this study: 1. Patient must have invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies. 2. AJCC Stage I or IIA (T1N0 or T2N0) histologically confirmed invasive carcinoma of the breast with a primary lesion (less than/equal to 3 cm)by MRI or ultrasound 3. Clinically negative axillary lymph nodes. Standard routine imaging assessment of the axilla is performed by either ultrasound or MRI. If lymph nodes are suspicious, a biopsy is required. An involved axilla is purposely excluded. 4. Unifocal breast cancer (single focus which can be encompassed by one lumpectomy). 5. Patients must have an estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth receptor 2 (H2N) analyses performed on the primary tumor prior to enrollment. 6. Based on pre-treatment planning CT scan, the ratio of the PTV to the reference breast volume should not exceed 25%. 7. Patients must be greater than/equal to 18 years of age. 8. Pretreatment evaluations required for bilateral mammogram, histologic confirmation of malignancy, and physical exam. 9. Signed study-specific informed consent form prior to study entry. 10. Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study: 1. Evidence of suspicious microcalcifications which are separate from the known lesion unless pathologically confirmed to be benign. 2. Patient with distant metastases. 3. Patients with invasive lobular or extensive in-situ lobular carcinoma or pure ductal carcinoma in-situ or non-epithelial breast malignancies such as sarcoma or lymphoma. 4. Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. 5. Patient whose tumor is not visible on radiation treatment planning CT scan 6. Palpable or radiographically suspicious ipsilateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. 7. Prior hormonal or non-hormonal therapy or radiation therapy for the current breast cancer. 8. Patients with Paget's disease of the nipple. 9. Patients with skin involvement, regardless of tumor size. 10. Patients with a breast technically unsatisfactory for radiation therapy. 11. Patients with collagenous diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis. 12. Patients with co-existing medical conditions with life expectancy less than 2 years. 13. Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. 14. Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules and all subjects with newly diagnosed breast cancer will be eligible to participate Anyone < 18 years of age
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0
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The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 18.0-999.0, Breast Cancer Postmenopausal women with breast cancer eligible for hormonal therapy Pregnant breast-feeding premenopausal
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0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
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eligible ages (years): 21.0-999.0, Breast Cancer Well stained breast tissue slides with bright Her2 signals Very old slides that were already bleached
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2
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