A Phase II Study of Durvalumab and Olaparib in Patients with Triple-Negative Breast Cancer

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Full Title

Phase II Multicenter Study of Durvalumab (MEDI4736) and Olaparib in Platinum Treated Advanced Triple Negative Breast Cancer - DORA

Purpose

The purpose of this study is to assess the safety and effectiveness of olaparib alone and in combination with durvalumab in patients with inoperable or metastatic triple-negative breast cancer that has responded to treatment with platinum-containing chemotherapy. Researchers want to determine if these treatments may be beneficial when used as maintenance therapy after platinum chemotherapy.

Patients will be randomly assigned to receive olaparib alone or olaparib plus durvalumab. Olaparib is taken orally (by mouth) and durvalumab is given intravenously (by vein).

Eligibility

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

  • Patients must have inoperable or metastatic triple-negative breast cancer that has shrunk or disappeared after at least four cycles of platinum-based therapy.
  • Patients may have received one or two chemotherapy regimens for advanced disease (including the platinum drugs).
  • Patients may not have previously received olaparib or other PARP inhibitors nor immunotherapy drugs like durvalumab.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 21 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Protocol

19-128

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases