drugset
drugset / Trial / NCT05862064

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

NCT05862064 ↗

Phase 3 Recruiting 606 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.

Timeline

Start
2023-06-01
Primary completion
2026-07-01
Completion
2028-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Epirubicin Small molecule 80 mg/m2 Intravenous
Background Epirubicin Small molecule 90 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous

Indications

triple-negative breast carcinoma