NCT06992336

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 411 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-10
• Primary completion: 2031-04-10
• Completion: 2036-01-01
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: China