RecruitingPhase 2NCT04501523

A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC

A Prospective, Phase II Trial Using Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer


Sponsor

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

Enrollment

460 participants

Start Date

Aug 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test that detects traces of cancer DNA (called ctDNA) to guide decisions about whether patients with triple-negative breast cancer (a harder-to-treat type) need additional radiation therapy after chemotherapy and surgery. **You may be eligible if...** - You have been diagnosed with triple-negative breast cancer (a type that lacks estrogen, progesterone, and HER2 receptors) - Your cancer is stage II or III - You received chemotherapy before surgery (neoadjuvant chemotherapy) - You are 18 years or older **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are pregnant - You have had prior radiation to your chest area - You have certain other serious health conditions that would prevent you from receiving radiation 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

DRUGTislelizumab

200mg, q3w, for 1 year

DRUGcapecitabine

600-750 mg/m2 PO Bid,continuous, for 1 year


Locations(1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China

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NCT04501523


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