A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

Summary:

Mutations of human tumor suppressor genes BRCA 1 and BRCA 2 have been linked to breast cancer. Currently, the FDA-approved chemotherapy drugs, Temozolomide (Temodar®), carboplatin and paclitaxel, have been widely used as a first treatment for advanced or metastatic (spread to/from other areas) cancer. The effect of these drugs may be improved with the addition of an experimental drug called Veliparib, which can prevent the cancer cells from repairing themselves and resume growing after chemotherapy treatment. The purpose of this study is to determine whether patients with the BRCA 1 or BRCA 2 mutation and metastatic breast cancer do better with or without veliparib in combination to chemotherapy treatment.

Eligibility and Treatment Plan:

• 18 years of age or older
• Breast cancer with evidence of metastatic disease
• Must have documented BRCA1 or BRCA2 germline mutation
• Measurable lesion on CT scan
• Adequate blood, kidney, and liver function
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
• Patients who have received anticancer agents within 28 days prior to study are not eligible.

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