Monitoring Circulating Tumor DNA During Capecitabine Treatment for Early Triple-Negative Breast Cancer

This study is looking at how a "liquid biopsy" called circulating tumor DNA (ctDNA) can help doctors understand if capecitabine treatment is working for people with early triple-negative breast cancer (TNBC). You might be able to join if you are at least 18 years old, have stage I-III TNBC, and still have some cancer remaining after initial chemotherapy. Participants will receive capecitabine for 8 cycles and have their blood monitored for ctDNA changes over time. The goal is to see if ctDNA levels can predict who benefits from capecitabine, which could help guide future treatment decisions to reduce the risk of cancer returning. The study plans to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 40 participants.
What's involved
You would receive capecitabine for 8 cycles, with each cycle lasting 21 days. Your blood will be monitored for ctDNA changes during this treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures ctDNA detection at 6 months, suggesting monitoring will occur at least for this period.

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NCT04768426

Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Stanford University
~40 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Capecitabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline levels of ctDNA detection
Measured over 6 months
Triple Negative Breast Cancer
Breast Cancer

NCT04768426

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Melinda Telli · PRINCIPAL_INVESTIGATOR · Stanford Universiy

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  • Baseline levels of ctDNA detection6 months

    In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are: * ctDNA+ (ctDNA-positive) at baseline and at 6 months. * ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months. * ctDNA- at baseline and at 6 months. * ctDNA- at baseline but ctDNA+ at 6 months. The outcome is a number without dispersion.