A Phase I Study of Rucaparib plus Radiation Therapy in Women with Triple-Negative Breast Cancer Who Did Not Respond Completely to Presurgical Chemotherapy

Full Title

A Phase I Study of Rucaparib Administered Concurrently with Postoperative Radiotherapy in Patients with Triple Negative Breast Cancer with an Incomplete Pathologic Response Following Neoadjuvant Chemotherapy

Purpose

PARP is a protein that helps cells, including cancer cells, repair their DNA. Some cancer cells may rely on the PARP protein to repair their DNA and survive. If the PARP protein is blocked, these cells may die. PARP inhibitors can also make some triple-negative breast cancer cells respond better to radiation therapy.

Rucaparib is a PARP inhibitor used to treat ovarian cancer. In this study, researchers are determining the highest dose of rucaparib that can be given safely in combination with radiation therapy in women with triple-negative breast cancer who had presurgical chemotherapy and then breast cancer surgery, but whose disease persists despite these treatments. Rucaparib 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 nonmetastatic triple-negative breast cancer and evidence of disease remaining in breast tissue or lymph nodes despite chemotherapy before surgery.
  • Patients may not have previously received a PARP inhibitor.
  • Patients may not receive chemotherapy, immunotherapy, or biologic therapy within 2 weeks of starting radiation therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Atif Khan at 848-225-6334.

Protocol

18-002

Phase

I

Investigator

Co-Investigators

Diseases