Clinical Trial

Olaparib In Metastatic Breast Cancer

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This research study is for patients with metastatic breast cancer. * Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. * This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. * Olaparib is a type of drug known as a PARP inhibitor. Some types of breast cancer and ovarian cancer share some basic features that make them sensitive to similar treatments. Information from those other research studies suggests that this drug may help to treat metastatic breast cancer. * This study will evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in one of the other genes that function with BRCA1 and BRCA2 to repair damaged DNA .This mutation may have been inherited from a parent, or may have developed only in the tumor. * This study will also evaluate whether olaparib is effective in breast cancer patients whose tumor has a mutation in BRCA1 or BRCA2 that was acquired by the tumor, but not inherited.
Protocol Amendment History 27 amendments
This ClinicalTrials.gov record has been amended 27 times since 2017-11-13; most recent amendment 2025-12-31.
Status change: Recruiting → Active, Not Recruiting 2024-02-16
Status change: Active, Not Recruiting → Recruiting 2020-08-10
Status change: Recruiting → Active, Not Recruiting 2020-01-27
Status change: Not Yet Recruiting → Recruiting 2018-03-27
Trial Details
NCT Number NCT03344965
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: Johns Hopkins University, AstraZeneca, Dana-Farber Cancer Institute
Conditions Metastatic Breast Cancer, Invasive Breast Cancer, Somatic Mutation Breast Cancer (BRCA1), Somatic Mutation Breast Cancer (BRCA2), CHEK2 Gene Mutation, ATM Gene Mutation, PALB2 Gene Mutation, RAD51 Gene Mutation +2 more
Enrollment 114 participants
Start Date 2018-04-01
Primary Completion 2025-07-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-05