The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer.
Abraham JE., Pinilla K., Dayimu A., Grybowicz L., Demiris N., Harvey C., Drewett LM., Lucey R., Fulton A., Roberts AN., Worley JR., Chhabra A., Qian W., Vallier A-L., Hardy RM., Chan S., Hickish T., Tripathi D., Venkitaraman R., Persic M., Aslam S., Glassman D., Raj S., Borley A., Braybrooke JP., Sutherland S., Staples E., Scott LC., Davies M., Palmer CA., Moody M., Churn MJ., Newby JC., Mukesh MB., Chakrabarti A., Roylance RR., Schouten PC., Levitt NC., McAdam K., Armstrong AC., Copson ER., McMurtry E., Tischkowitz M., Provenzano E., Earl HM.
PARTNER is a prospective, phase II-III, randomized controlled clinical trial that recruited patients with triple-negative breast cancer1,2, who were germline BRCA1 and BRCA2 wild type3. Here we report the results of the trial. Patients (n = 559) were randomized on a 1:1 basis to receive neoadjuvant carboplatin-paclitaxel with or without 150 mg olaparib twice daily, on days 3 to 14, of each of four cycles (gap schedule olaparib, research arm) followed by three cycles of anthracycline-based chemotherapy before surgery. The primary end point was pathologic complete response (pCR)4, and secondary end points included event-free survival (EFS) and overall survival (OS)5. pCR was achieved in 51% of patients in the research arm and 52% in the control arm (P = 0.753). Estimated EFS at 36 months in the research and control arms was 80% and 79% (log-rank P > 0.9), respectively; OS was 90% and 87.2% (log-rank P = 0.8), respectively. In patients with pCR, estimated EFS at 36 months was 90%, and in those with non-pCR it was 70% (log-rank P < 0.001), and OS was 96% and 83% (log-rank P < 0.001), respectively. Neoadjuvant olaparib did not improve pCR rates, EFS or OS when added to carboplatin-paclitaxel and anthracycline-based chemotherapy in patients with triple-negative breast cancer who were germline BRCA1 and BRCA2 wild type. ClinicalTrials.gov ID: NCT03150576 .