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Olaparib Expanded - Treating Metastatic Breast Cancer in People without gBRCA Mutations

Clinicaltrials.gov identifier:
NCT03344965


Study Contact Information:

For additional information, please contact the coordinating center by email.  

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

 About the Study

This study is no longer recruiting people. 

DFCI 17-428 ( Expanded) is a study looking at whether the drug is effective treatment for people with certain types of breast cancer.  belongs to a class of drugs known as PARP inhibitors. PARP inhibitors are particularly effective for treating tumors in people with an inherited mutation. This study is looking at whether is also effective for treating breast cancer in people who do not have an inherited mutation.

The study is looking at to treat breast cancer in two specific groups of patients who have tested negative for a mutation:

  • People with breast cancer whose tumor has a in or . This means that although the patient does not have an inherited mutation, their tumor cells have developed mutations in either of these genes.
  • Patients with an or tumor mutation in .

Type of Study

This is a Phase 2, 2-arm, study evaluating in breast cancer patients with either a non-BRCA (inherited) mutation or a somatic (acquired) mutation found in the blood or tumor tissue. Participants with a or germline mutation are not eligible for this study, as is already approved for these patients. Response to treatment will be analyzed by periodic assessments of the tumor by CT scans.

  • The study is , meaning that all patients will receive the drug, . The study has two arms:
    • Cohort 1 is open to patients with a (inherited) mutation in one of the repair genes that is associated with breast cancer, other than and .
    • Cohort 2 is open to patients with a (mutation in their tumor) in or or one of the other repair genes that is associated with breast cancer.

What the Study Entails

  • breast cancer patients (women or men) will qualify for the study provided they have a mutation in one of the repair genes described above
  • Study participants will take , a tablet medication, by mouth. The oral dose of  will be taken 2 times per day, 12 hours apart with food.
  • Each study treatment cycle lasts 21 days (3 weeks)
  • Treatment will continue until you are no longer benefitting from the treatment (disease progression), you experience intolerable side effects or you decide you no longer wish to participate
  • A biopsy for research purposes is required prior to the start of treatment on this study
  • A follow-up visit will occur 30 days after you come off treatment to assess any side effects of the study drug
  • Participants will be monitored every 6 weeks for the first 24 weeks for assessment of disease and then every 12 weeks thereafter.

Study Sites

For a full list of open sites, see the clinicaltrials.gov listing.

Principal Investigator

The study PI is Nadine Tung, MD: 617-667-1962 or by email. 

This Study is Open To:

This study is no longer recruiting people. 

This Study is Not Open To:

This study is no longer recruiting people.