A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

Completed · Phase 3

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

In brief

The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

Key facts

Study ID

NCT01945775

Run by

Pfizer

People needed

431

Starts

2013-10-14

Expected to finish

2021-03-05

Last updated by the study team

2022-01-20

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 breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
• Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor
• No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)
• Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
• Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

You may not qualify if…

• First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
• Prior treatment with a PARP inhibitor (not including iniparib)
• Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
• Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
• Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
• Cytotoxic chemotherapy within 14 days before randomization
• Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
• HER2 positive breast cancer
• Active inflammatory breast cancer
• CNS metastases
• Exception: 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 ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
• Subjects with leptomeningeal carcinomatosis are not permitted
• Prior malignancy except for any of the following:
• Prior BRCA-associated cancer as long as there is no current evidence of the cancer
• Carcinoma in situ or non-melanoma skin cancer
• A cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence
• Known to be human immunodeficiency virus positive
• Known active hepatitis C virus, or known active hepatitis B virus
• Known hypersensitivity to any of the components of talazoparib

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• Virginia G. Piper Cancer Pharmacy — Scottsdale, Arizona, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California, United States
• CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Fairfield, California, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Gilroy, California, United States
• Los Angeles Hematology Oncology Medical Group — Glendale, California, United States
• Los Angeles Hematology Oncology Medical Group — Glendale, California, United States
• Marin Specialty Care — Greenbrae, California, United States
• Los Angeles Hematology Oncolgy Medical Group — Los Angeles, California, United States
• Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States
• Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• Drug Management only: UCLA West Medical Pharmacy — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D. — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• Regulatory Managment Only: TRIO-US Central Administration — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• TRIO-US Central Administration — Los Angeles, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Arizona Oncology Associates P.C. - NAHOA — Flagstaff, Arizona, United States

Full record on ClinicalTrials.gov

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