What are the inclusion and exclusion criteria for the OlympiA trial enrolling adults (≥ 18 years, ≥ 30 kg) with germline BRCA1/2 pathogenic mutations and early‑stage HER2‑negative (human epidermal growth factor receptor 2‑negative) breast cancer who have completed definitive surgery and (neo)adjuvant chemotherapy?

OlympiA Trial Inclusion and Exclusion Criteria

Inclusion Criteria

The OlympiA trial enrolled patients with germline BRCA1/2-mutated, HER2-negative early breast cancer at high risk of recurrence who had completed definitive local treatment and (neo)adjuvant chemotherapy. 1

Patient Demographics

• Age ≥18 years and weight ≥30 kg 1

Genetic Requirements

• Germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants (confirmed mutation required for enrollment) 1

Tumor Characteristics

• HER2-negative breast cancer (both hormone receptor-positive and triple-negative subtypes were eligible) 2, 1
• High-risk clinicopathological features defined by specific criteria based on hormone receptor status 1

High-Risk Criteria by Subtype

For Triple-Negative Breast Cancer (ER-negative):

• Tumor size ≥2 cm, OR 3
• Any involved axillary lymph nodes 3

For Hormone Receptor-Positive Disease (ER-positive):

• ≥4 involved axillary lymph nodes 3

Treatment Requirements

• Completion of definitive local treatment (surgery and radiation therapy as indicated) 1
• Completion of (neo)adjuvant chemotherapy prior to randomization 1
• Patients must have received standard chemotherapy appropriate for their disease stage 1

Key Exclusion Criteria (Inferred from Trial Design)

Disease-Related

• HER2-positive breast cancer (trial specifically enrolled HER2-negative disease) 1
• Metastatic disease at enrollment (trial was limited to early-stage breast cancer) 1
• Low-risk disease not meeting the high-risk clinicopathological criteria outlined above 1

Treatment-Related

• Patients who had not completed their planned (neo)adjuvant chemotherapy 1
• Patients who had not completed local treatment including indicated radiation therapy 3

Clinical Context

Approximately 13.3% of patients with HER2-negative early breast cancer meet these high-risk criteria, with substantial variation by subtype: 7.5% of HR+/HER2- patients and 46.8% of triple-negative breast cancer patients qualify 4. Among high-risk patients, approximately 44.6% meet traditional criteria for hereditary cancer testing, meaning the remaining patients require BRCA testing specifically based on their high-risk disease characteristics 5.

The trial demonstrated that 1 year of adjuvant olaparib following completion of all standard treatments significantly improved outcomes, with 3-year invasive disease-free survival of 85.9% versus 77.1% with placebo (HR 0.58; 99.5% CI, 0.41-0.82; P<0.001) 1. This benefit was observed across both hormone receptor-positive and triple-negative subtypes 1.