A Phase II Study of Veliparib plus Temozolomide, Veliparib plus Carboplatin and Paclitaxel, or Carboplatin and Paclitaxel with Placebo in Patients with BRCA Mutations and Metastatic Breast Cancer

Protocol
12-122
Full Title
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
Phase
II
Purpose

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.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic breast cancer and a mutations in the BRCA1 or BRCA2 genes.
  • Patients with HER2-positive disease must have continued to experience cancer growth despite therapy that targets this protein (such as Herceptin).
  • Patients may not have received more than one prior regimen of therapy for metastatic disease.
  • At least 3 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study, please contact Dr. Mark Robson at 646-888-5434.

Disease(s)
Breast Cancer
Locations
Related Diseases