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Men and women with Stage IV breast cancer who do not have an inherited BRCA1 or BRCA2 mutation and:
Men or Women will be excluded if:
For additional information, please contact the coordinating center by email.
DFCI 17-428 (Olaparib Expanded) is a study looking at whether the drug Olaparib is effective treatment for people with certain types of metastatic 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 BRCA mutation. This study is looking at whether olaparib is also effective for treating metastatic breast cancer in people who do not have an inherited BRCA mutation.
The study is looking at olaparib to treat metastatic breast cancer in two specific groups of patients who have tested negative for a BRCA mutation:
This is a Phase 2, non-randomized 2-arm, open-label study evaluating olaparib in metastatic breast cancer patients with either a non-BRCA germline (inherited) mutation or a somatic (acquired) mutation found in the blood or tumor tissue. Participants with a BRCA1 or BRCA2 germline mutation are not eligible for this study, as Olaparib is already FDA approved for these patients. Response to treatment will be analyzed by periodic assessments of the tumor by CT scans.
For a full list of open sites, see the clinicaltrials.gov listing.
The study PI is Nadine Tung, MD: 617-667-1962 or by email.