A PHASE II, RANDOMIZED STUDY OF PACLITAXEL WITH GDC-0941 VERSUS PACLITAXEL WITH PLACEBO IN PATIENTS WITH LOCALLY RECURRENT OR METASTATIC BREAST CANCER

Genentech, Inc.0 个研究点目标入组 180 人开始时间: 2013年3月6日最近更新: 2016年5月17日

适应症

试验速览

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•? Age > 18
•? Women with histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non measurable locally recurrent or metastatic disease
•?Human epidermal growth factor receptor 2 (HER2)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•?Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
•?For patients who have received
•- prior treatment with capecitabine in the metastatic setting, treatment must have been completed < 2 weeks prior to Cycle 1, Day 1.Prior treatment with a PI3K inhibitor for advanced breast cancer or MBC (including but not limited to GDC 0941, GDC 0980, BEZ235, BKM120, BYL719, LY294002, PIK-75, TGX-221, XL147, XL765, SF1126, PX-866, D 87503, D-106669, GSK615, CAL101)
•Prior mTOR inhibitors (e.g., everolimus) are permitted provided treatment concluded at least 2 weeks prior to Cycle 1, Day 1.
•?History of intolerance to a taxane-containing therapy
•?History of clinically significant cardiac or pulmonary dysfunction
•?History of malabsorption syndrome or other condition that would interfere with enteral absorption
•?Clinically significant history of liver disease
•?Active autoimmune disease or active inflammatory disease
•?Immunocompromised status
•?Need for current chronic corticosteroid therapy
•?Pregnancy, lactation, or breastfeeding
•?Current severe, uncontrolled systemic disease
•?Known untreated or active central nervous system (CNS) metastases

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