Trial ID or NCT#

NCT02034916

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: - Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or - Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

Official Title

A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Melinda L. Telli, M.D.
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Associate Professor of Medicine (Oncology)
Allison W. Kurian, M.D., M.Sc.
Allison W. Kurian, M.D., M.Sc.
Medical oncologist, Breast specialist, Cancer geneticist
Professor of Medicine (Oncology) and of Epidemiology and Population Health
George W. Sledge Jr., M.D.
George W. Sledge Jr., M.D.
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)

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CONTACT

CCTO
(650) 498-7061