A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

Stopped early · Phase 2

Conditions studied: Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation

In brief

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

Key facts

Study ID

NCT02034916

Run by

Pfizer

People needed

84

Starts

2013-12-13

Expected to finish

2018-10-31

Last updated by the study team

2019-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed carcinoma of the breast
• Locally advanced and/or metastatic disease
• Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation
• Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
• ECOG performance status ≤ 1
• Have adequate organ function

You may not qualify if…

• Prior enrollment into a clinical trial of a PARP inhibitor
• 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 HIV positive, active hepatitis C virus, or active hepatitis B virus
• Known hypersensitivity to any of the components of talazoparib

Where it is running

• UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• TRIO-US Central Administration — Los Angeles, California, United States
• Stanford Women's Cancer Center — Palo Alto, California, United States
• UCLA Hematology Oncology- Porter Ranch — Porter Ranch, California, United States
• Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates — Redondo Beach, California, United States
• University of California, San Francisco: Helen Diller Comprehensive Cancer Center — San Francisco, California, United States
• UCLA Hematology-Oncology — Santa Monica, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Sylvester at Deerfield Beach — Deerfield Beach, Florida, United States
• Memorial Cancer Institute at Memorial Regional Hospital — Hollywood, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• University of Miami Hospital & Clinics — Miami, Florida, United States
• Memorial Breast Cancer Center at Memorial Hospital West — Pembroke Pines, Florida, United States
• Memorial Cancer Institute at Memorial Hospital West — Pembroke Pines, Florida, United States
• Memorial Hospital West — Pembroke Pines, Florida, United States
• Sylvester at Plantation — Plantation, Florida, United States
• ICRC — Indianapolis, Indiana, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Investigational Drug Services — Indianapolis, Indiana, United States
• IU Health University Hospital — Indianapolis, Indiana, United States
• Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States
• Springmill Medical Clinic — Indianapolis, Indiana, United States
• Marin Cancer Care, Inc. — Greenbrae, California, United States

Full record on ClinicalTrials.gov

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