Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
A Phase II, Open-label, Randomized Trial to Compare Anlotinib and Immunotherapy and Capecitabine Versus Investigator's Choice Therapy in High Risk ctDNA Positive, Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
411 participants
Apr 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- Stage II-III breast cancer patients, excluding occult breast cancer, inflammatory breast cancer, metaplasia breast cancer
- TNBC patients. TNBC was defined as ER \<= 10%, PR \<=10%, HER 0-1, or HER2 2+ and FISH negative.
Exclusion Criteria1
- \-
Interventions
Anlotinib 8mg qd PO，357days
Benmelstobart 200mg i.v. Q3W
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06992336