NCT04501523

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tislelizumab	200mg, q3w, for 1 year
DRUG	capecitabine	600-750 mg/m2 PO Bid，continuous, for 1 year

Timeline

• Start date: 2020-08-03
• Primary completion: 2027-08-01
• Completion: 2032-08-01
• First posted: 2020-08-06
• Last updated: 2023-02-21

Locations

1 site across 1 country: China