- Germline BRCA 1/2 Mutation Positive
- Women and men at least 18 years of age or older.
- Histologically confirmed invasive triple negative Breast Cancer
- Tumor >1.5 cm.
- No evidence of distant metastasis
- Adequate bone marrow, hepatic, and renal function
- ECOG performance status 0 or 1
- Any previous antitumor therapies for the current cancer event
- Evidence of distant metastasis apparent prior to randomization
- Patients with inflammatory breast carcinoma
- Malignancy within the last 3 years
- Previous or concomitant systemic anti cancer therapies used for the treatment of
cancer in the last 3 years.
- Prior treatment with a PARP inhibitor in any disease setting
- Concomitant use of P gp inhibitors or inducers or BCRP inhibitors
- Patients who are unwilling or unable to use 2 highly effective methods of
contraception as outlined in this protocol
- Major surgery within 14 days prior to study entry
- No known history of cardiovascular disease
- Active clinically significant infection
- Clinically significant bleeding diathesis or coagulopathy
- Non healing wound, ulcer or bone fracture
- Known hypersensitivity to any of the components of talazoparib
- Patients with myelodysplastic syndrome/acute myeloid leukemia
- Patients with uncontrolled seizures.
- Any evidence of other disease or any concomitant medical or psychiatric problems which
in the opinion of the Investigator would prevent completion of treatment