A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
Condition(s) studied
Investigational drug(s) / intervention(s)
Tislelizumab: 200mg, q3w, for 1 year
capecitabine: 600-750 mg/m2 PO Bid,continuous, for 1 year
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.
Eligibility
Primary outcome measure(s)
- 5 years Disease free survival(DFS) — 60 months
From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Sunyat-sen Memorial Hospital | Guandong | Guangdong | Recruiting |
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04501523 on ClinicalTrials.gov ↗ ← All trials in China