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

What this Trial Is About

Researchers are studying triple-negative breast cancer (TNBC), focusing on how circulating tumor DNA (ctDNA) levels after treatment can predict the risk of cancer returning. This trial aims to improve outcomes for TNBC patients by identifying those with high relapse risk through ctDNA testing and offering additional boost therapy post-surgery. The study is a phase II clinical trial evaluating this approach in patients who have undergone neoadjuvant chemotherapy (NAC). Participants who test positive for ctDNA and have not achieved a complete pathological response (non-pCR) after NAC are randomly assigned to receive either a combination of tislelizumab, an anti-PD1 antibody given at 200 mg every three weeks for one year, plus capecitabine, or standard treatment with capecitabine alone at 600-750 mg/m2 twice daily continuously for one year. Those who are ctDNA positive but have achieved a complete pathological response receive capecitabine. The trial also includes a follow-up group receiving standard care. During the study, participants will have frequent blood tests every three months and other evaluations to monitor disease status and treatment effects. Researchers will measure disease-free survival over five years as the primary outcome, along with overall survival, remission rates, brain metastasis, response rates, safety, and relapse rates over periods extending up to ten years. The total follow-up includes long-term monitoring to understand how well patients do after treatment.

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