Abstract 179P
Background
Immune checkpoint inhibitors have shown promising efficacy in patients with triple-negative breast cancer in the neoadjuvant and metastatic settings. Whether the addition of anti-PD1 antibody camrelizumab to chemotherapy would increase the rate of pathological complete response (pCR) for early triple-negative breast cancer is unclear.
Methods
In this phase 2 study, eligible patients were aged 18 to 60 years, had previously untreated early triple-negative breast cancer, and Eastern Cooperative Oncology Group performance status of 0-1. Patients received 6 cycles of camrelizumab (200 mg, once every 3 weeks) plus nab-paclitaxel (125 mg/m2, on days 1, 8, and 15) and epirubicin (75 mg/m2, once every 3 weeks), followed by surgery. The primary endpoint was the total pCR (tpCR; ypT0/is, ypN0) rate. Using a Simon’s two-stage design, 4 of 9 patients were required to achieve tpCR in the first stage, with a prespecified tpCR rate of 55% before proceeding to the second stage. A total of 39 participants was required for the study.
Results
Eight out of 9 patients achieved tpCR in the first stage, reaching the threshold for the second stage. From January 2020 to April 2021, a total of 25 patients was enrolled and 15 received surgery after the completion of neoadjuvant therapy. tpCR was observed in 86.7% (13/15) of patients and the trial accrual is ongoing. The most common grade 3 or 4 treatment-related adverse events were leucopenia (68%), neutropenia (40%), and anemia (16%). No treatment-related deaths occurred.
Conclusions
Camrelizumab plus nab-paclitaxel and epirubicin resulted in higher rate of tpCR in patients with early triple-negative breast cancer and had a manageable toxicity profile. Further study is warranted to validate our findings.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.