RecruitingPhase 2Phase 3NCT04803539

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

A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)


Sponsor

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

Enrollment

260 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is for people with triple-negative breast cancer (a type that lacks the three most common receptors, making it harder to treat) who have finished surgery and chemotherapy but still show signs of cancer in a blood test. It tests whether giving additional treatment guided by that blood test (ctDNA — tiny fragments of cancer DNA in blood) can reduce the chance of the cancer coming back. **You may be eligible if...** - You are 18 or older - You have Stage II or III triple-negative breast cancer - You have had surgery and chemotherapy - After treatment, a blood test (ctDNA) is still positive, suggesting cancer may still be present **You may NOT be eligible if...** - Your ctDNA test is negative after treatment - You have not completed the standard surgery and chemotherapy - You have other active cancers 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGcapecitabine

capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial)

DRUGcapecitabine + camrelizumab + apatinib

Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study


Locations(1)

Sunyat-sen Memorial Hospital

Guandong, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04803539


Related Trials