A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 versus Physician’s Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer, Who Have Received No More than 2 Prior Chemotherapy Regimens for Metastatic Disease

BioMarin Pharmaceutical Inc.0 个研究点目标入组 431 人开始时间: 2014年2月24日最近更新: 2021年5月25日

试验速览

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•Histologically or cytologically confirmed carcinoma of the breast
•Locally advanced and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
•Deleterious or pathogenic germline BRCA1 or BRCA2 mutation
•No more than 2 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease
•Prior treatment with a taxane and/or anthracycline in the adjuvant or metastatic setting
•ECOG performance status = 1
•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 429
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Prior treatment with a PARP inhibitor
•Prior platinum treatment for metastatic disease. Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible
•CNS metastasis except adequately treated brain metastasis documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids 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 of the cervix or non-melanoma skin cancer, and a cancer diagnosed and definitively treated =5 years prior to study enrollment with no subsequent evidence of recurrence
•Known to be human HIV positive, active hepatitis C virus, or active hepatitis B virus
•Known hypersensitivity of any of the components of BMN 673

发起方