Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced Breast Cancer
M.D. Anderson Cancer Center
Summary
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic). Olaparib, cediranib, and AZD6738 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Description
PRIMARY OBJECTIVE: I. To assess the objective response rate (ORR) of olaparib plus cediranib and olaparib plus ceralasertib (AZD6738) combinations in patients with advanced or metastatic breast cancer with germline BRCA (breast cancer susceptibility gene) mutations who have been previously treated with PARP inhibitors. SECONDARY OBJECTIVES: I. To assess the safety and tolerability of olaparib in combination with cediranib and in combination with AZD6738 in patients with advanced or metastatic breast cancer with germline BRCA mutations. II. To assess duration of response (DOR) to treatment.…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures 2. Women age greater than 18 years with advanced/metastatic HER2 negative, BRCA germline positive breast cancer. Estrogen receptor positive (ER+) patients must have progressed on a prior endocrine therapy or are considered inappropriate for any FDA approved endocrine therapies for ER+ breast cancer. 3. Eligible patients must agree to a mandatory fresh biopsy (excluding bone) at screening. In addition, if available, an archival tissue sample will also be collected at screening. 4. Patients must have nor…
Interventions
- DrugCediranib
Given PO
- DrugCeralasertib
Given PO
- DrugOlaparib
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas