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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

Summary

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.

Official Title

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

Keywords

Breast Neoplasms BRCA 1 Gene Mutation BRCA 2 Gene Mutation Breast cancer BRCA mutation PARP inhibitor BRCA 1 BRCA 2 Poly(ADP-ribose) Polymerase Inhibitors Talazoparib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • San Francisco, California, 94115, United States
  • Greenbrae, California, 94904, United States
  • Palo Alto, California, 94305, United States
  • Vallejo, California, 94589, United States
  • Bakersfield, California, 93309, United States
  • San Luis Obispo, California, 93401, United States
  • Santa Maria, California, 93454, United States
  • Santa Barbara, California, 93105, United States
  • Los Angeles, California, 90017, United States
  • Downey, California, 90241, United States
  • Redondo Beach, California, 90277, United States
  • Los Angeles, California, 90095, United States
  • Fullerton, California, 92835, United States
  • Las Vegas, Nevada, 89169, United States
  • San Marcos, California, 92078, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Medivation, Inc.
ID
NCT01945775
Phase
Phase 3
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
May 1, 2017