Study of Adding Olaparib to Platinum-Based Chemotherapy Before Surgery in Patients With Triple Negative or Germline BRCA Positive Breast Cancer

What this Trial Is About

Researchers are studying breast cancer patients who have Triple Negative Breast Cancer TNBC andor a germline BRCA mutation gBRCA to see if adding olaparib, a PARP enzyme inhibitor, to platinum-based neoadjuvant chemotherapy is safe and improves the complete response rate at surgery. This is a randomized, open-label phase IIIII trial conducted in three stages, involving at least 780 patients, including 220 with gBRCA mutations. Participants receive at least 21 weeks of chemotherapy before surgery. Study groups include a control arm receiving paclitaxel and carboplatin, and two experimental arms where patients receive the same chemotherapy plus oral olaparib tablets taken twice daily during specified days of each 3-week cycle. Additional treatments such as prophylactic granulocyte-colony stimulating factor and anthracyclines are given as per local practice. Patients with residual disease after chemotherapy may join a sub-study with further treatments. During the trial, patients undergo screening tests including BRCA mutation testing, tumor marker assessments, and standard cancer staging. Researchers monitor treatment safety and effectiveness through pathological complete response rates, adverse events, survival outcomes, quality of life questionnaires, and imaging. Follow-up occurs for up to 10 years after surgery, with safety data regularly reviewed by independent committees to ensure participant well-being.

Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer