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

NCT04501523 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

Tislelizumab

200mg, q3w, for 1 year

DRUG

capecitabine

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

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Qiang Liu, MD · Sunyat-sen Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2027-08-31
Completion
2032-08-31

Countries

  • China

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Entities

Drugs

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 NCT04501523 on ClinicalTrials.gov