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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Capecitabine; Drug: Anlotinib ,; Drug: Benmelstobart

Study type: Interventional

Funder types: Other

Identifiers

NCT06992336

SYSKY-2025-281-01

Details and patient eligibility

About

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.

Enrollment: 411 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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411 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Benmelstobart

Drug: Anlotinib ,

Drug: Capecitabine

B

Active Comparator group

Description:

Investigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years.

Treatment:

Drug: Capecitabine