In the phase II GeparOLA trial, Neoadjuvant #Olaparib plus paclitaxel was not superior to Paclitaxel-carboplatin regarding long-term outcomes in patients with Her-2 negative, high homologous recombination deficiency (HRD), early breast cancer.

In this randomized phase II trial that was presented at SABCS 2022, 107 eligible patients with primary HER2-negative cT2-cT4a-d or cT1c with high-risk features (i.e., cN+ or SLN+ or TNBC or Ki-67>20%) and HRD, defined as having a known germline or somatic BRCA1/2 mutation or a high HRD score via MyChoice assay (score ≥ 42). Patients were randomly assigned 2:1 to receive weekly paclitaxel plus olaparib 100mg bid daily or paclitaxel plus carboplatin weekly for 12 weeks. Both arms also received epirubicin/cyclophosphamide (EC) every 2 or 3 weeks.

Long term results showed that iDFS, DDFS and OS were inferior in the Olaparib arm. The 4-year iDFS rate was 76.0% with olaparib vs 88.5% with carboplatin (HR=2.86). Similarly, the 4-year DDFS rate was 81.2% vs 93.4% (HR, 3.03), respectively. The 4-year OS rate was 89.2% vs 96.6% (HR=3.27). Meanwhile, the iDFS in patients with germline/somatic BRCA mutations were comparable between the 2 arms.