Capecitabine in ER+/HER2-negative Breast Cancer (NCT07631052) | Clinical Trial Compass
RecruitingPhase 2
Capecitabine in ER+/HER2-negative Breast Cancer
Canada15 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \<6 months prior to screening,
. Symptomatic chronic heart failure (e.g., New York Heart Association Class ≥ 2), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality \<6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia.
. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite current therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people who still have detectable cancer DNA in the blood after initial treatment — called molecular residual disease — so could my doctor test me for that using something like the Pathlight assay to see if I might even be a candidate worth discussing?
2Since this is a Phase 2 trial, the main goal seems to be figuring out whether capecitabine can clear this leftover cancer DNA rather than proving it improves survival — so what does that mean for understanding the actual benefit versus risk for someone in my situation?
3Capecitabine is being used here in a 'metronomic' way, meaning lower doses given more frequently than standard chemotherapy — how does that dosing approach change what side effects I should expect compared to regular capecitabine treatment?
4The trial measures ctDNA clearance at 16 weeks, which means committing to at least that much time on this regimen — how would joining this study fit alongside or potentially delay other standard treatment options I might have for early-stage ER-positive, HER2-negative breast cancer?
5If my ctDNA doesn't clear by the 16-week mark, what would the next steps look like, and is there any concern that being in this trial could affect my eligibility for other treatments down the road?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clearance rate of ctDNA at 16 weeks after the use of metronomic capecitabine measured using the Pathlight assay in patients with molecular residual disease (MRD). ctDNA clearance is defined as no detection of plasma ctDNA.