RecruitingPhase 2NCT07631052

Capecitabine in ER+/HER2-negative Breast Cancer

Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease in ER+/HER2-negative Breast Cancer


Sponsor

University Health Network, Toronto

Enrollment

15 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 study for patients with resected Stage I-III HR+/HER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo/adjuvant and locoregional therapy delivered with curative intent. In this study participants will be treated with capecitabine. Capecitabine will be administered orally at a dose of 500 mg 3 times daily for up to 12 months, or until the time of clinical recurrence, discontinuation due to toxicity, or withdrawal of consent. This study will have two stages, stage 1 would enroll up to 8 participants to clear the Minimal Residual Disease (MRD) and Stage 2 will enroll up to 5 participants. The purpose of this study is to determine if this study population would have a better outcome from receiving capecitabine rather than having no change in treatment if MRD is detected.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Capecitabine for people with breast cancer stage i, breast cancer stage ii, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

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 500 mg


Locations(1)

UHN - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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

Visit

NCT07631052


Related Trials