Actively Recruiting
Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease in ER+/HER2-negative Breast Cancer
Led by University Health Network, Toronto · Updated on 2026-06-05
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with resected Stage I-III hormone receptor-positive (HR+), HER2-negative breast cancer who have molecular residual disease (MRD+) detected after standard therapies given with curative intent. This Phase 2 study aims to see if treating these patients with capecitabine improves outcomes compared to no treatment change when MRD is present. The study is sponsored by the University Health Network, Toronto. Participants will receive capecitabine orally at a dose of 500 mg three times daily for up to 12 months or until clinical recurrence, unacceptable side effects, or withdrawal of consent. The study has two stages: Stage 1 will enroll up to 8 participants to assess MRD clearance, and Stage 2 will enroll up to 5 participants. Treatment will be monitored using the Pathlight assay to measure circulating tumor DNA (ctDNA). Throughout the study, participants will undergo testing to measure ctDNA clearance at 16 weeks, with no ctDNA detected indicating clearance. Secondary measures include distant recurrence-free survival for up to 5 years, assessment of treatment-related side effects, and ongoing ctDNA monitoring for about 3 years. Participants must comply with scheduled visits, examinations, and follow-ups, with safety monitored throughout the study period ending in 2029.
CONDITIONS
Brief Title
Capecitabine in ER+/HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older with histologically confirmed resected ER-positive/HER2-negative stage I-III breast cancer
- Evidence of molecular residual disease (MRD) positive by the Pathlight assay after standard adjuvant therapy
- No contraindications to capecitabine including absence of certain DPYD gene variants
- No clinical or imaging signs of recurrent or metastatic disease
- Received at least 24 months of adjuvant endocrine therapy including 6 months of an aromatase inhibitor
- Received at least 12 months of adjuvant CDK4/6 inhibitor therapy if indicated unless not tolerated or declined
- ECOG performance status of 0 or 1
- Adequate organ function including kidney, bone marrow, and liver as defined by specific laboratory criteria
- Female participants of childbearing potential must have a negative serum beta-HCG test and agree to use highly effective contraception
- Male participants must agree to use highly effective contraception
- Willing and able to comply with study procedures and visits
- Signed informed consent
You will not qualify if you...
- Prior therapy with capecitabine
- Previous or concurrent malignancy within 3 years except certain treated non-invasive or indolent cancers
- Significant cardiovascular disease including recent acute coronary syndrome, symptomatic heart failure, significant arrhythmias, or uncontrolled hypertension
- Known uncontrolled HIV infection
- Active hepatitis B or hepatitis C infection unless adequately suppressed
- Impaired gastrointestinal function affecting capecitabine absorption
- Medical, psychiatric, cognitive, or other conditions that may affect ability to consent, comply, or complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive capecitabine 500 mg as part of their treatment.
Visits scheduled throughout the 16 weeks of treatment
Duration - Up to 3 years
Participants are monitored for treatment effects, recurrence, and ctDNA levels for up to 3 years after treatment.
Periodic visits during follow-up for assessments
Trial Site Locations
Total: 1 location
1
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
Research Team
D
David Cescon, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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