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RECRUITING
NCT07631052
PHASE2

Capecitabine in ER+/HER2-negative Breast Cancer

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-06-30

Completion Date

2029-08-01

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

Capecitabine

Capecitabine 500 mg

Locations (1)

UHN - Princess Margaret Cancer Centre

Toronto, Ontario, Canada