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Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 antiangiogenic therapy, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
Official title: A Phase II, Open-Label, Randomized Study Comparing Antiangiogenic Therapy Combined With Immunotherapy and Capecitabine Versus Investigator's Choice in Patients With Circulating Tumor DNA-Positive Stage II-III Triple-Negative Breast Cancer Who With Residual Disease After Neoadjuvant Therapy
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2025-04-10
Completion Date
2036-01-01
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Apatinib, Camrelizumab
Apatinib 8mg qd PO，357days Camrelizumab 200mg q3w 17 cycles in total (including immunotherapy used in the NAC period)
Capecitabine
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Locations (1)
Sun Yat-sen Memorial Hospital
Guangzhou, Guangodng, China