Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk. This trial aims to explore whether the combination of anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
Conditions studied
Breast Cancer
About this study
Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk. This trial aims to explore whether the combination of anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
Interventions
- Drug: Anlotinib , — Anlotinib 8mg qd PO，357days
- Drug: Benmelstobart — Benmelstobart 200mg i.v. Q3W
- Drug: Capecitabine — Capecitabine 1000 or 1250 mg/m2 BID day1-14
Primary outcomes
- iDFS (from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months.)
Eligibility information
Study locations
- Sun Yat-sen Memorial Hospital, Guangzhou, Guangodng China
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.