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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 anlotinib, 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 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
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
411
Start Date
2025-04-10
Completion Date
2036-01-01
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
Anlotinib ,
Anlotinib 8mg qd PO,357days
Benmelstobart
Benmelstobart 200mg i.v. Q3W
Capecitabine
Capecitabine 1000 or 1250 mg/m2 BID day1-14
Locations (1)
Sun Yat-sen Memorial Hospital
Guangzhou, Guangodng, China