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

NCT06992336 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2025-05-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2031-04-10
Completion
2036-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06992336 on ClinicalTrials.gov