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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 (M12-895)

Protocol Number:

J11110

Phase:

Phase II

Physician:

Vered Stearns

Purpose:

The purpose of this research study is to learn if patients who have a BRCA1 or BRCA2 mutation and metastatic breast cancer do better with veliparib (an experimental drug) given in combination with chemotherapy. Patients who take part are randomly assigned (like flipping a coin) to one of three treatment groups: 1) Veliparib and Temozolomide; 2) Veliparib and Carboplatin and Paclitaxel; 3) Placebo and Carboplatin and Paclitaxel. Temozolomide (Temodar), carboplatin and paclitaxel are approved chemotherapy drugs that are often used to treat metastatic cancer.

Eligibility:

Patient with a diagnosis of metastatic breast cancer who also have a BRCA1 or BRCA2 mutation may join this research study.

Treatment:

You will first be consented and tested to see if you are a carrier of the BRCA1 or BRCA2 mutation if this testing has not been done in the past. If you are a carrier of the BRCA1 or BRCA2 mutation, and are eligible to take part, you will be randomized to one of three treatment groups described above. Veliparib, the placebo and temozolomide are all oral drugs. Carboplatin and paclitaxel are IV drugs that will be given into a vein in the the clinic. You will have routine blood tests, EKG and scans before you start on study and these will be repeated while you are on study. On certain days you will have extra research blood work done. During your first treatment cycle you will need to come to the clinic on days 1, 15, and 22. You will then return to the clinic every 3 or 4 weeks for study visits. You will stay on this study as long as your cancer is responding and the study drugs are not too hard on you.

Population:

Adult

Last Update

05/22/2013 04:02 AM

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