Capecitabine in ER+/HER2-negative Breast Cancer

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.

NCT Number	NCT07631052
Lead Sponsor	University Health Network, Toronto
Conditions	ER-positive, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Enrollment	15 participants
Start Date	2026-06-30
Primary Completion	2029-08-01 (estimated)
Study Completion	2029-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-11