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RECRUITING
NCT04501523
PHASE2

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

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

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.

Official title: A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

460

Start Date

2020-08-03

Completion Date

2032-08

Last Updated

2023-02-21

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

200mg, q3w, for 1 year

DRUG

capecitabine

600-750 mg/m2 PO Bid,continuous, for 1 year

Locations (1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China