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Nature ; 629(8014): 1142-1148, 2024 May.
Article in English | MEDLINE | ID: mdl-38588696

ABSTRACT

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 .


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Neoadjuvant Therapy , Phthalazines , Piperazines , Triple Negative Breast Neoplasms , Adult , Aged , Female , Humans , Middle Aged , Anthracyclines/therapeutic use , Anthracyclines/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/administration & dosage , Carboplatin/therapeutic use , Genes, BRCA1 , Genes, BRCA2 , Paclitaxel/administration & dosage , Paclitaxel/therapeutic use , Pathologic Complete Response , Phthalazines/administration & dosage , Phthalazines/therapeutic use , Piperazines/administration & dosage , Piperazines/therapeutic use , Progression-Free Survival , Prospective Studies , Survival Analysis , Time Factors , Triple Negative Breast Neoplasms/drug therapy , Triple Negative Breast Neoplasms/metabolism , Triple Negative Breast Neoplasms/surgery , Adolescent , Young Adult
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