ER-positive, HER2-negative Breast CancerPhase 2NCT07631052
Capecitabine in ER+/HER2-negative Breast Cancer
A Phase 2 study testing Capecitabine in people with ER-positive, HER2-negative Breast Cancer and Breast Cancer Stage I, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ER-positive, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jul 2026to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine)
- No clinical or radiographic evidence of recurrent or metastatic disease
- Previous Therapy requirements: (i) Received at least 24 months of adjuvant endocrine therapy, including 6 months of an aromatase inhibitor and (i) Received at least 12 months of adjuvant CDK4/6i if indicated, unless not tolerated or declined
- ECOG performance status of 0-1.
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- Patient must have adequate organ function as determined by the following:
- Renal function:
- Serum creatinine < 1.5 x ULN (upper limit of normal range) or a calculated creatinine clearance of > 50mL/min using the Cockcroft-Gault formula
- Bone marrow function (without hematopoietic growth factors or transfusion):
- Absolute neutrophil count (ANC) > 1.0 x 109/L
- Hemoglobin > 90 g/L or > 9g/dL
- Platelets > 75 x 109/L
- Liver function:
- Total bilirubin ≤ 1.5 × ULN and < 35 uMol/L; OR total bilirubin >1.5 × ULN with indirect bilirubin < 1.5 × ULN.
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 2.5 x ULN.
- Female participants of childbearing potential must have a negative serum β-HCG test result at enrolment.
- Female participants of childbearing potential must agree to use methods of contraception that are highly effective.
- Male participants must agree to use methods of contraception that are highly effective.
- The participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Signed written and voluntary informed consent.
Who cannot join
- Prior therapy with capecitabine.
- Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other non-invasive or indolent malignancy; other solid tumors treated curatively without evidence of recurrence for at least 3 years prior to study entry.
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- 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.
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- Known positive serology for HIV (Human immunodeficiency virus) that is not currently controlled with antiretroviral therapy.
- Has a known history of or is positive for active hepatitis B or hepatitis C unless adequate viral suppression is achieved. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.
- Impaired gastrointestinal function or disease that may significantly alter the absorption of capecitabine.
- Medical, psychiatric, cognitive, or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
David Cescon, 416-946-2245 ext. 16-2245, Dave.Cescon@uhn.ca
Dave Cescon
About this study
Official title: Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease 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.
- Conditions
- ER-positive, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Capecitabine 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Capecitabine 500 mg Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following Week 16 of treatment
Secondary outcomes (3)
Distant recurrence free survival (DRFS).
Describe clinical outcomes for MRD+ patients treated with this escalated strategy, including distant recurrence free survival (DRFS).
Measured: Time of consent signed through to follow up (up to 5 years)
Number and severity of treatment related adverse events as assessed by CTCAE v5.0.
Measured: Time of consent signed through to 30 days last dose of study drug
Measure ctDNA levels in MRD positive patients using the Pathlight assay after initiation of metronomic capecitabine.
Measured: Time of consent signed through study completion, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start29 Jul 2026
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER-positive, HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631052
- Sponsor's protocol ID
- CATER MRD
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capecitabine for Targeted Eradication of aRising ctDNA Molecular Residual Disease in ER+/HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07631052
- Acronym / sponsor ID
- CATER MRD
- Conditions
- ER-positive, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineCapecitabine 500 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine)
- No clinical or radiographic evidence of recurrent or metastatic disease
- Previous Therapy requirements: (i) Received at least 24 months of adjuvant endocrine therapy, including 6 months of an aromatase inhibitor and (i) Received at least 12 months of adjuvant CDK4/6i if indicated, unless not tolerated or declined
Key exclusion criteria (10 listed)
- Prior therapy with capecitabine.
- Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other non-invasive or indolent malignancy; other solid tumors treated curatively without evidence of recurrence for at least 3 years prior to study entry.
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- Known positive serology for HIV (Human immunodeficiency virus) that is not currently controlled with antiretroviral therapy.
- Has a known history of or is positive for active hepatitis B or hepatitis C unless adequate viral suppression is achieved. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineCapecitabine 500 mg | Drug | Capecitabine |
Primary outcome
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.
Time frame: Following Week 16 of treatment
3 secondary outcomes
Distant recurrence free survival (DRFS).
Time frame: Time of consent signed through to follow up (up to 5 years)
Number and severity of treatment related adverse events as assessed by CTCAE v5.0.
Time frame: Time of consent signed through to 30 days last dose of study drug
Measure ctDNA levels in MRD positive patients using the Pathlight assay after initiation of metronomic capecitabine.
Time frame: Time of consent signed through study completion, approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with ER-positive, HER2-negative Breast Cancer and Breast Cancer Stage I, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Cescon, MD (416-946-2245, dave.cescon@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Following Week 16 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.