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New trial aims to outsmart cancer by adjusting chemo doses in real time

NCT ID NCT06525766

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether giving the chemotherapy drug capecitabine in a flexible, response-based way (adaptive therapy) can better control metastatic ER-positive breast cancer. About 35 adults with advanced, hormone-resistant disease will receive doses that are adjusted based on tumor scans and blood markers. The goal is to see if this personalized dosing can slow tumor growth while reducing side effects.

What this could mean

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

Active substance
capecitabine (Xeloda)
What this could lead to
If successful, this approach could offer a way to control metastatic breast cancer with fewer side effects by adjusting doses based on tumor response.
What could go wrong
This is a small, early-phase pilot study with only 35 participants. It may not show a clear benefit, and capecitabine can cause side effects like hand-foot syndrome and fatigue.

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 35 people

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

Started

Oct 2025

Expected to finish

Oct 2030

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: * PRE-REGISTRATION: Provide written informed consent Note: Pre-registration should occur prior to screening research blood draws being completed * PRE-REGISTRATION: Provider anticipates the patient will begin on capecitabine within 14 days or has started capecitabine within the past 42 days and has had a maximum of two cycles Note: Pre-registration should occur prior to screening research blood draws being completed REGISTRATION - INCLUSION CRITERIA * Age ≥ 18 years * Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, metastatic breast cancer * Measurable disease. Bone only disease allowed if associated with soft tissue component that is measurable by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration) * Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration) * Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Provide written informed consent * Ability to complete questionnaire(s) by themselves or with assistance * Willingness to provide mandatory blood specimens for correlative research * Ability to undergo re-staging CT scans as required by the protocol * Note: for patients who have had up to two cycles of capecitabine prior to joining the study, they must have had their initial CT imaging completed within 28 days of their first dose of capecitabine * Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study) * Cohort 2 only: Stable disease, partial or complete response on imaging after beginning capecitabine Exclusion Criteria: * Prior chemotherapy or use of antibody drug conjugate in the metastatic setting * Note - Cohort 2 only: Patients can have had up to two cycles of capecitabine before joining the study * Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects: * Pregnant persons * Nursing persons * Persons of childbearing potential who are unwilling to employ adequate contraception * Any of the following prior therapies: * Major surgery ≤ 3 weeks prior to registration * Radiation therapy ≤ 2 weeks prior to registration * Evidence of visceral crisis or impending cord compression * Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention * Uncontrolled intercurrent illness including, but not limited to: * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * uncontrolled cardiac arrhythmia * chronic oxygen dependence * respiratory failure * or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix * If there is a history of prior malignancy, they must not be receiving other cancer specific treatment. Except for antiestrogen treatment (aromatase inhibitors or selective estrogen modulators) for their cancer are permitted if they meet other eligibility criteria. Denosumab and zoledronic acid, are permitted as established adjunct therapies per guidelines * History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity. Test results do not need to be available prior to registration * History of severe hypersensitivity reactions to fluorouracil or capecitabine

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

    Contact Email: •••••@•••••

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