A Phase I Study of Veliparib Given with Radiation Therapy to the Chest Wall and Lymph Nodes in Patients with Inflammatory or Recurrent Breast Cancer

Protocol
12-215
Full Title
A Phase 1 Study of Veliparib Administered Concurrently with Chest Wall and Nodal Radiation Therapy in Patients with Inflammatory or Loco-regionally Recurrent Breast Cancer (TBCRC 024)
Phase
I
Purpose

The purpose of this study is to find the highest dose of the investigational drug veliparib that can be given safely with radiation to the chest wall and lymph nodes in patients who have had a mastectomy in the past and are experiencing a recurrence of breast cancer in the chest wall or nearby areas, or in patients with inflammatory breast cancer that has been recently removed by mastectomy. Researchers hope that veliparib may enhance the beneficial effects of radiation therapy.

Veliparib (also known as ABT-888) is known as a PARP inhibitor. It kills cancer cells by blocking the PARP protein, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more vulnerable to anticancer treatments. Veliparib is a pill that is taken orally (by mouth).

Eligibility

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

  • Patients must have inflammatory breast cancer that was recently removed with a mastectomy, or a recurrence of breast cancer in the chest wall or nearby areas after having had a mastectomy in the past.
  • At least 3 weeks must pass between completion of breast cancer surgery and initiation of radiation therapy.
  • Any other treatments (such as chemotherapy or targeted therapies) must be completed at least 2 weeks before beginning radiation therapy.
  • Patients may not have had prior radiation therapy to the chest wall or regional lymph nodes.
  • Patients who have had breast reconstruction may not be eligible to participate.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alice Ho at 212-639-6773.

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