Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Anlotinib ,; Drug: Benmelstobart; Drug: Capecitabine

• Registration Number: NCT06992336
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-10
• Study First Submitted: 2025-04-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-24
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2031-04-10
• Study Completion: 2036-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 411

Inclusion Criteria

• 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 Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Anlotinib ,	Anlotinib 8mg qd PO，357days Benmelstobart 200mg i.v. Q3W or immunotherapy continued as in the NAC. Capecitabine 1000 或 1250 mg/m2 BID day1-14
A	Benmelstobart	Anlotinib 8mg qd PO，357days Benmelstobart 200mg i.v. Q3W or immunotherapy continued as in the NAC. Capecitabine 1000 或 1250 mg/m2 BID day1-14
A	Capecitabine	Anlotinib 8mg qd PO，357days Benmelstobart 200mg i.v. Q3W or immunotherapy continued as in the NAC. Capecitabine 1000 或 1250 mg/m2 BID day1-14
B	Capecitabine	Investigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years.

Primary Outcome Measures

Name	Time	Method
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.	invasive disease free survival

Secondary Outcome Measures

Name	Time	Method
dDFS	from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months	distant disease free survival
OS	from randomization to any of the following events: death of any cause，assessed up to 120 months	overall survival
ctDNA clearance	From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months	the rate of patients whose ctDNA are positive after surgery and turns negative after boost therapy

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangodng, China