A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients

Inclusion Criteria

• •1. Germline mutation in BRCA1 or BRCA2
• •2. Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
• •3. Prior therapy with an anthracycline and/or a taxane in either an adjuvant or metastatic setting
• •4. Patients who have received platinum (cisplatin or carboplatin, either as monotherapy or in combination) for advanced breast cancer are eligible to enter the study provided platinum-free interval at least 6 months (time from last dose of platinum chemotherapy to disease progression
• •5. Patients who have received platinum as potentially curative treatment for a prior cancer (e.g. ovarian cancer) or as adjuvant/neoadjuvant treatment for breast cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and eligible .
• •6. Patients with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy .
• •7. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1.
• •8. ECOG performance status 0-1.
• •9. Adequate bone marrow, kidney and liver function