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n engl j med 364;3 nejm. org january 20, 2011 205The new england journal of medicine established in 1812 january 20, 2011 vol. 364 no. 3 Iniparib plus Chemotherapy in Metastatic Triple-Negative Breast Cancer Joyce O'Shaughnessy, M. D., Cynthia Osborne, M. D., John E. Pippen, M. D., Mark Yoffe, M. D., Debra Patt, M. D.,... | ID_1_Phase II_ OShaughnessy 2011.pdf |
The new england journal of medicine n engl j med 364;3 nejm. org january 20, 2011 206Metastatic triple-negative brea st cancer — which is estrogen-receptor (ER)-negative and progesterone-recep-tor (PR)-negative and has no overexpression of human epidermal growth factor receptor type 2 (HER2) — is an aggressive subtype ... | ID_1_Phase II_ OShaughnessy 2011.pdf |
Iniparib plus Chemotherapy in Triple-Negative Breast Cancer n engl j med 364;3 nejm. org january 20, 2011 207Study Design The study was approved by the central institution-al review board of US Oncology (www. usoncology . com) and complied with the provisions of the Good Clinical Practice guidelines. The study was spon... | ID_1_Phase II_ OShaughnessy 2011.pdf |
The new england journal of medicine n engl j med 364;3 nejm. org january 20, 2011 208benefit in the chemotherapy-alone group was as-sumed to be approximately 0. 45. If the rate of clinical benefit in the iniparib group was 0. 674 or greater, then — on the basis of a one-sided test of equality of proportions at the 5% l... | ID_1_Phase II_ OShaughnessy 2011.pdf |
Iniparib plus Chemotherapy in Triple-Negative Breast Cancer n engl j med 364;3 nejm. org january 20, 2011 209and 59 patients in the chemotherapy-alone group. These 116 patients were included in the safety analysis. As of the date of data cutoff, November 16, 2009, a total of 6 of the 57 patients (11%) in the iniparib g... | ID_1_Phase II_ OShaughnessy 2011.pdf |
The new england journal of medicine n engl j med 364;3 nejm. org january 20, 2011 210Overall, the two treatment groups were well-balanced with regard to the baseline character-istics of the patients ( Table 1 ). A total of 60% and 57% of patients in the chemotherapy-alone and iniparib groups, respectively, received stu... | ID_1_Phase II_ OShaughnessy 2011.pdf |
Iniparib plus Chemotherapy in Triple-Negative Breast Cancer n engl j med 364;3 nejm. org january 20, 2011 211In 1 of the 30 patients (3%), there was an uncon-firmed partial response, and 4 of the 30 patients (13%) had stable disease. Safety Table 3 lists the most common adverse events in the safety population. The most... | ID_1_Phase II_ OShaughnessy 2011.pdf |
The new england journal of medicine n engl j med 364;3 nejm. org january 20, 2011 212Table 3. Common Adverse Events in the Safety Population. * Event Gemcitabine-Carboplatin and Iniparib (N = 57)Gemcitabine-Carboplatin Alone (N = 59) Any Grade 3 Grade 4 Any Grade 3 Grade 4 number of patients (percent) Any event 57 (100... | ID_1_Phase II_ OShaughnessy 2011.pdf |
Iniparib plus Chemotherapy in Triple-Negative Breast Cancer n engl j med 364;3 nejm. org january 20, 2011 213the safety population, 8 of 57 patients (14%) in the iniparib group and 13 of 59 patients (22%) in the chemotherapy-alone group discontinued treatment because of adverse events. The dose of gemcitabine was reduc... | ID_1_Phase II_ OShaughnessy 2011.pdf |
n engl j med 364;3 nejm. org january 20, 2011 214Iniparib plus Chemotherapy in Triple-Negative Breast Cancer negative breast cancer, adequately powered to study overall survival and progression-free sur-vival, is being conducted (Clinical Trials. gov num-ber, NCT00938652). Supported by Bi Par Sciences (now owned by San... | ID_1_Phase II_ OShaughnessy 2011.pdf |
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