A Phase II Trial of Camrelizumab in Combination With Apatinib and Eribulin in Patients With Advanced TNBC

This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with apatinib and eribulin in female patients age of 18 to 70 with advanced TNBC, and previously treated with at least one line of systemic therapy in the advanced setting. Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and a taxane. The number of patients to be included is 46 patients (Simons two stage design). The primary objective is to assess the overall response rate (ORR). All enrolled patients will be treated with camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 21-day cycle, and apatinib 250mg daily (po, d1-d21), in combination with eribulin mesylate at 1.4 mg/m2 (iv.) on day 1 and day 8 of every 21-day cycle.