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

Recruiting Phase 3 Interventional Study
TNBC - Triple-Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
606 (estimated)
Sponsor
Fudan University · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Sign the Informed Consent Form (ICF) 2. The patient is judged by the investigator to have the ability to comply with the provisions of the protocol 3. Women aged 18\~70 at the time of signing the ICF 4. Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1…
Contacts

Zhimin Shao, MD,PhD

+86-021-64175590

zhimingshao@yahoo.com

CONTACT