The purpose of this study is to assess different combinations of anticancer drugs in patients in metastatic breast cancer who also have mutations in the BRCA genes. These genes normally work to suppress tumor growth, but people who have mutated BRCA have an increased risk of breast and other cancers.
Patients will be randomly assigned to receive one of three treatments:
- The investigational drug veliparib with the drug temozolomide.
- Veliparib plus carboplatin and paclitaxel.
- Carboplatin and paclitaxel with a placebo.
Veliparib (also known as ABT-888) kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer drugs. It can also work well in cancer cells that do not have functional BRCA, which helps to fix DNA damage. Veliparib is a pill that is taken orally (by mouth).
Temozolomide is approved for the treatment of brain cancer, but its use in breast cancer is considered investigational. Carboplatin and paclitaxel are routinely used to treat several types of cancer.