Capecitabine in ER+/HER2-negative Breast Cancer

Recruiting Phase 2 Interventional Study
ER-positive, HER2-negative Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
University Health Network, Toronto · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or female patients ≥ 18 years of age with histologically confirmed (by local assessment with ASCO/CAP criteria), resected ER-positive/HER2-negative stage I-III breast cancer * Evidence of MRD (positive test by the Pathlight assay) despite standard adjuvant therapy * No co…
Contacts

David Cescon, MD

416-946-2245

dave.cescon@uhn.ca

CONTACT