A Phase II Study of Olaparib in Patients with Metastatic Breast Cancer with Certain Genetic Mutations

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Full Title

A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients with Germline or Somatic Mutations in DNA Repair Genes “Olaparib Expanded”

Purpose

Olaparib is a type of anticancer medication called a PARP inhibitor, which may slow down the process cancer cells use to repair their DNA. Cancer cells need to repair their DNA to survive and grow. Olaparib is already approved by the U.S. Food and Administration to treat metastatic breast cancer in patients who have inherited mutations in BRCA1 and BRCA2, which are both DNA repair genes.

In this study, researchers are assessing the safety and effectiveness of olaparib to treat metastatic breast cancer in women who have acquired BRCA1 or BRCA2 mutations in their cancers, or who were born with mutations in other DNA repair genes (such as PALB2, ATM, or CHEK2). Olaparib 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 metastatic breast cancer that continues to grow despite more than two prior regimens of chemotherapy for metastatic disease.
  • Patients must have an acquired (not inherited) BRCA1 or BRCA2 mutation or a mutation in another DNA repair gene.
  • At least 3 weeks must pass between the completion of prior therapies and entry into the study. Patients may not have previously received a PARP inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mark Robson at 646-888-5486 or Ange Syldor, Clinical Research Manager, at 646-888-5103.

Protocol

18-414

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases