OlympiA — Adjuvant Olaparib in Patients with Germline BRCA-Mutated High-Risk HER2-Negative Early Breast Cancer

Phase 3 · 2021 · Breast Cancer

Design

Randomized 1:1 to 1 year of adjuvant olaparib vs placebo after completion of local therapy and chemotherapy.

Population

Germline BRCA1/2-mutated, HER2-negative high-risk early breast cancer (TNBC or HR-positive).

Primary Endpoint

invasive disease-free survival (iDFS)

Key Result

4-yr iDFS 82.7% vs 75.4% (HR 0.63); 4-yr OS 89.8% vs 86.4% (HR 0.68).

Guideline Impact

NCCN category 1 for gBRCA-mutated high-risk HER2- early breast cancer