Clinical Trial DRUG M12-895
- 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
- Principal Investigator
- William Gradishar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG M12-895
- The main purpose of the study is to determine if patients with the BRCA1 or BRCA2 mutation and metastatic breast cancer do better with veliparib in combination with temozolomide or carboplatin and paclitaxel with or without veliparib.
- This study is for breast cancer patients who may be carriers of the BRCA1 or BRCA2 mutation with metastatic breast cancer. BRCA 1 and BRCA 2 are human genes that belong to a class of genes known as tumor suppressors. Mutation of these genes has been linked to breast cancer. Temozolomide (Temodar®), carboplatin and paclitaxel are Food and Drug Administration (FDA) approved chemotherapy drugs in both the United States and other countries and are widely used as a first treatment for advanced or metastatic (spread to/from other areas) cancer. Veliparib (also known as ABT-888) is a PARP inhibitor (blocker) that is not approved for use in the United States or any other countries, and is considered experimental. PARP is a naturally occurring protein made by the body that may help cancer cells overcome injury or damage caused by radiation and certain types of anti-cancer drugs, making these treatments less effective (don't work well). Veliparib inhibits (blocks) the activity of PARP. This blocking activity may prevent the cancer cell from repairing itself and resume growing. Veliparib when given together with certain chemotherapies such as temozolomide or carboplatin and paclitaxel may make the combination treatments work better by stopping the cancer cell from healing and growing.
Some of the eligibility criteria include:
- Participants must have metastatic breast cancer (it has spread beyond the breast) and must have a BRCA1 or BRCA2 mutation.
- Participants must be 18 or older.
- Both men and women are eligible.
- Description of Treatment
- Study participants will be randomly assigned (like flipping a coin) to one of three treatment groups: veliparib plus temozolomide; veliparib plus carboplatin and paclitaxel; or placebo plus carboplatin and paclitaxel
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by William Gradishar
- A Phase 2, Randomized, Open-Label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients with FGF Aberrant Metastatic Breast Cancer
- A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC)
last updated: 09-Oct-15 12:02 AM
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