Olaparib Maintenance Therapy in Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
Olaparib, a PARP inhibitor, is proven as an effective therapy for germline BRCA1/2-mutated
breast cancer; however, the therapeutic efficacy for somatic mutation in BRCA1/2 or genes of
homologous recombination DNA repair is unclear. Maintenance of Oalaprib can delay the disease
progression in patients with BRCA1/2 mutated advanced ovarian cancer after treatment with
platinum based chemotherapy. The investigators design a phase 2 study to evaluate the
efficacy of maintenance of Olaparib in patients with metastatic breast cancer. The
investigators enroll patients with metastatic ER(+)Her2(-) or triple-negative breast cancer.
Patients who are chemotherapy-naïve or prior 1-line chemotherapy are eligible for screening.
All eligible patients will receive 4 cycles of platinum based chemotherapy. Gene test will be
performed on their breast tumor. If patients have mutation of HR genes and at least stable
disease after platinum based chemotherapy, they will be randomized to treatment arm (Olaparib
maintenance) or control arm (continuation of chemotherapy). The primary end-point is
progression-free survival, and the secondary end-point is to assess the response rate,
overall survival and quality of life.