Breast Cancer 673-301

April 11, 2017

Sponsor: BioMarin

Number: 673-301
Eligible patients who enroll in the study will be randomly assigned (by chance) to this open-label, 2:1 randomized phase III trial (Phase III trials are new treatments that have worked well in a small number of patients with this disease) 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 (breast cancer that has spread beyond the breast to the chest wall or the skin of the breast, or to many lymph nodes in the underarm area, or to other organs ) with germline BRCA mutations.

Who’s eligible: 

  • The patient must have histologically (tissue microscopically examined) or cytological (fluid cells microscopically examined) confirmed carcinoma of the breast, with locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy.
  • The patient must have documentation of a deleterious, suspected deleterious or pathogenic germline BRCA1 or BRCA2 (tumor suppressor genes, or anti-oncogenes) 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 (locally advanced or metastatic- breast cancer that has spread beyond the breast to the chest wall or the skin of the breast, or to many lymph nodes in the underarm area, or to other organs).
  • This study is for patients age 18 and older

Available at: The Hospital of Central Connecticut- The Cancer Center of Central Connecticut.

Cancer Clinical Research Office