Journal for immunotherapy of cancer
Sintilimab plus eribulin and carboplatin in patients with metastatic triple-negative breast cancer (SECURE): a phase II, multicenter trial
By Ni M, Zhou L, Zhang L and 14 others.
Abstract
Background
The clinical benefit of combining chemotherapy with immunotherapy in metastatic triple-negative breast cancer (TNBC) varies depending on the chemotherapy backbone, highlighting the need for optimizing combination partners. This single-arm exploratory phase II trial evaluated the efficacy and safety of sintilimab combined with eribulin and carboplatin (ErCb) in patients with metastatic TNBC previously treated with anthracyclines and/or taxanes.
Methods
Eligible patients received eribulin 1.4 mg/m2 and carboplatin (area under the curve=2) on days 1 and 8, plus sintilimab 200 mg on day 8 of each 21-day cycle. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. The trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2400082647).