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drugset / Trial / NCT04501523

A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC

NCT04501523 ↗

Phase 2 Recruiting 460 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.

Timeline

Start
2020-08-03
Primary completion
2027-08
Completion
2032-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 600 mg/m2 Oral
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Tislelizumab Monoclonal antibody 200 mg —

Indications

triple-negative breast carcinoma