RecruitingPhase 3NCT05862064

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


Sponsor

Fudan University

Enrollment

606 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study tests whether adding a PD-1 immune checkpoint inhibitor and an anti-blood vessel drug to standard chemotherapy after surgery works better than chemotherapy alone in women with triple-negative breast cancer (a type that lacks hormone receptors and HER2). **You may be eligible if...** - You are a woman between 18 and 70 years old - You have stage IIA–IIIC triple-negative breast cancer that has been surgically removed - Your cancer was node-positive (lymph nodes were involved) - Surgery was completed within the past 8 weeks - You are in good general health (ECOG 0 or 1) with adequate organ function **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had any systemic cancer treatment prior to joining (this is for post-surgery adjuvant therapy) - You have serious heart, liver, kidney, or immune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGepirubicin,cyclophosphamide,paclitaxel,Carrelizumab

Conventional chemotherapy in combination with carrelizumab

DRUGepirubicin,cyclophosphamide,paclitaxel

Conventional chemotherapy


Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT05862064


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