EUCTR2013-002716-28-GB进行中（未招募）1 期
A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of Talazoparib (BMN 673) versus Physician’s Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens for Metastatic Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 431
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically or cytologically confirmed carcinoma of the breast
- •Locally advanced breast cancer that is not amendable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
- •Deleterious, suspected deleterious or pathogenic germline BRCA1 or BRCA2 mutation
- •No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease
- •Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting
- •ECOG performance status = 2
- •Have adequate organ function
- •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 375
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Prior treatment with a PARP inhibitor (not including iniparib)
- •Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease.
- •- Subjects who received platinum in the adjuvant or neoadjuvant setting are eligible
- •CNS metastases except adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone less than or equal to 5mg/day) for management of CNS symptoms
- •Prior malignancy except for prior BRCA-associated cancer as long as there is no current evidence of the prior cancer, carcinoma in situ or non-melanoma skin cancer, and a cancer diagnosed and definitively treated =5 years before randomization with no subsequent evidence of recurrence
- •Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus
- •Known hypersensitivity of any of the components of talazoparib
研究者
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