Phase III Study Comparing PD-1 Inhibitor and Antivascular Therapy Combined with AnthracyclineTaxane Chemotherapy Versus Chemotherapy Alone in Women With Operable High-Risk Triple-Negative Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining SHR1210 Camrelizumab and the antivascular drug Famitinib with anthracyclinetaxane-based adjuvant chemotherapy compared to conventional chemotherapy alone in patients with early-stage high-risk triple-negative breast cancer TNBC. This phase III, multi-center, randomized, open-label study focuses on women with operable TNBC to determine if the combined approach improves patient outcomes. Participants in the experimental group receive SHR1210 200 mg intravenously every two weeks and Famitinib 10 mg orally once daily alongside intensive chemotherapy consisting of epirubicin and cyclophosphamide every two weeks for four doses, followed by weekly paclitaxel or albumin-paclitaxel for 12 weeks. Maintenance therapy with SHR1210 and Famitinib continues to complete one year of treatment. The comparator group receives the conventional chemotherapy regimen alone following the same schedule. During the study, participants undergo regular assessments including laboratory tests, physical exams, and monitoring for disease recurrence over five years. The primary outcome is invasive disease-free survival measured at five years. Secondary outcomes include distant disease-free survival and overall survival at five years. The study includes safety monitoring and requires adherence to scheduled visits and treatment protocols throughout the trial duration.

A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer