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The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer
Jean E Abraham1,2, Karen Pinilla3,4, Alimu Dayimu5
1Precision Breast Cancer Institute, Department of Oncology, University of Cambridge, Cambridge, UK. ja344@cam.ac.uk.
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 .
Insights
Neoadjuvant olaparib did not improve outcomes for patients with triple-negative breast cancer (TNBC) who were germline BRCA1 and BRCA2 wild type. The PARTNER trial found no significant differences in pathologic complete response, event-free survival, or overall survival between treatment arms.
Area of Science:
- Oncology
- Clinical Trials
- Breast Cancer Research
Background:
- Triple-negative breast cancer (TNBC) lacks targeted therapies, necessitating novel treatment strategies.
- Germline BRCA1/2 mutations are associated with specific breast cancer subtypes, but their role in wild-type TNBC treatment response is under investigation.
- The PARTNER trial evaluated the efficacy of adding olaparib to standard neoadjuvant chemotherapy for TNBC patients with wild-type germline BRCA1/2.
Purpose of the Study:
- To determine if neoadjuvant olaparib improves pathologic complete response (pCR) in patients with germline BRCA1/2 wild-type TNBC.
- To assess the impact of neoadjuvant olaparib on event-free survival (EFS) and overall survival (OS) in this patient population.
- To evaluate the safety and efficacy of combining olaparib with carboplatin-paclitaxel and anthracycline-based chemotherapy.
Main Methods:
- A prospective, phase II-III, randomized controlled trial (PARTNER) involving 559 patients with TNBC and wild-type germline BRCA1/2.
- Patients were randomized 1:1 to receive neoadjuvant carboplatin-paclitaxel with or without olaparib, followed by anthracycline-based chemotherapy.
- Primary endpoint was pCR; secondary endpoints included EFS and OS. Olaparib was administered on a gap schedule for four cycles.
Main Results:
- No significant difference in pCR rates between the olaparib arm (51%) and the control arm (52%) (P=0.753).
- Event-free survival at 36 months was 80% in the olaparib arm and 79% in the control arm (P>0.9).
- Overall survival at 36 months was 90% in the olaparib arm and 87.2% in the control arm (P=0.8).
Conclusions:
- Neoadjuvant olaparib, when added to standard chemotherapy, did not improve pCR, EFS, or OS in patients with germline BRCA1/2 wild-type TNBC.
- The addition of olaparib to neoadjuvant carboplatin-paclitaxel and anthracycline-based chemotherapy is not beneficial for this specific TNBC subgroup.
- Further research may be needed to identify predictive biomarkers for PARP inhibitor efficacy in TNBC patients without germline BRCA mutations.
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