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

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

Clinicaltrials.gov identifier:
NCT03344965

Treatment

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

DFCI 17-428 (Olaparib Expanded) is a study looking at whether the drug Olaparib is effective treatment for people with certain types of breast cancer. Olaparib 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 olaparib is also effective for treating breast cancer in people who do not have an inherited mutation.

The study is looking at olaparib 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 mutation 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 inherited mutation or tumor mutation in .

Type of Study

This is a Phase 2, 2-arm, study evaluating olaparib in breast cancer patients with either a non-BRCA germline (inherited) mutation or a (acquired) mutation found in the blood or tumor tissue. Participants with a or germline mutation are not eligible for this study, as Olaparib 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, olaparib. The study has two arms:
    • Cohort 1 is open to patients with a germline (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 (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 Olaparib, a tablet medication, by mouth. The oral dose of olaparib 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:

Men and women with IV breast cancer who do not have an inherited or mutation and:

  • have a documented inherited, in  or have a acquired () mutation in a repair gene or found through testing.
  • participants must have at least one site of measurable disease.
  • participants may have progressed on no more than 2 prior chemotherapy lines in the setting.
  • history of prior anthracycline and/or taxane based chemotherapy is preferred.
  • must be willing to undergo a research biopsy before starting treatment.
This Study is Not Open To:

Men or Women will be excluded if:

  • they have an inherited mutation in  or mutation.
  • they have had treatment with a in the past.
  • they are unable or unwilling to swallow oral medication.
  • they have had another malignancy within the last 5 years other than non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ () or 1 endometrial carcinoma.
  • they have unstable central nervous system or brain . Stable brain is allowed.