Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06992336
PHASE2

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

View on ClinicalTrials.gov

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

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

Locations (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangodng, China