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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2025-07-16

No results posted yet for this study

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.

Conditions

  • TNBC - Triple-Negative Breast Cancer

Interventions

DRUG

epirubicin,cyclophosphamide,paclitaxel,Carrelizumab

Conventional chemotherapy in combination with carrelizumab

DRUG

epirubicin,cyclophosphamide,paclitaxel

Conventional chemotherapy

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05862064 on ClinicalTrials.gov