RecruitingPhase 2NCT06992336

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


Sponsor

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

Enrollment

411 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether patients with triple-negative breast cancer (TNBC) who still have detectable cancer DNA in the blood (called circulating tumor DNA or ctDNA) after initial chemotherapy should receive additional targeted 'boost' therapy to eliminate remaining cancer cells. **You may be eligible if...** - You have been diagnosed with stage II or III triple-negative breast cancer - Your cancer is triple-negative (low or no hormone receptors, HER2-negative) - You are receiving or planning to receive standard chemotherapy before surgery (neoadjuvant therapy) **You may NOT be eligible if...** - You have inflammatory breast cancer, occult (hidden) breast cancer, or metaplastic breast cancer - (No further specific exclusion criteria were listed) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib ,

Anlotinib 8mg qd PO,357days

DRUGBenmelstobart

Benmelstobart 200mg i.v. Q3W

DRUGCapecitabine

Capecitabine 1000 or 1250 mg/m2 BID day1-14


Locations(1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangodng, China

View Full Details on ClinicalTrials.gov

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NCT06992336


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