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Can a chemo pill mop up hidden breast cancer cells?

NCT ID NCT07631052

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether the chemotherapy pill capecitabine can eliminate tiny amounts of cancer DNA still present in the blood after standard treatment for early-stage ER+/HER2- breast cancer. About 15 patients whose blood tests show residual cancer DNA will take capecitabine for up to 12 months. The main goal is to see if the cancer DNA becomes undetectable, which might lower the chance of the cancer coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Capecitabine (chemotherapy pill)
What this could lead to
If successful, this could offer a way to eliminate lingering cancer cells detected by a blood test, potentially reducing the risk of cancer returning.
What could go wrong
This is a very small early-phase trial with only 15 participants, so results may not apply broadly. Capecitabine can cause side effects like hand-foot syndrome and digestive issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. * Patient must have adequate organ function as determined by the following: a. 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 b. 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 c. 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. Exclusion Criteria: * 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: 1. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \<6 months prior to screening, 2. 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. 3. Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite current therapy. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UHN - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

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