Adaptive Therapy with Capecitabine for Metastatic ER Positive, HER2 Negative Breast Cancer
This study is looking at a treatment called capecitabine for people with metastatic (spread to other parts of the body) breast cancer that is estrogen-receptor positive (ER+) and HER2-negative. Capecitabine is a medication that works by killing cancer cells. The study will use imaging and tumor markers to adjust the dose of capecitabine, a method called adaptive therapy. The main goal is to see if this adaptive therapy approach can be successfully used. You may be able to join if you are 18 or older and have this specific type of metastatic breast cancer. The study aims to see if this approach can slow or stop cancer growth.
- Study design
- This is an interventional study with a planned enrollment of 35 participants. It is a single-arm study, meaning all participants receive the same intervention.
- What's involved
- You would undergo blood sample collection, bone scans, CT scans, and MRI scans. You would also take capecitabine by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure the ability to achieve adaptive therapy for up to 5 years.
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NCT06525766
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~35 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanCapecitabineComputed TomographyMagnetic Resonance ImagingQuestionnaire Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability to achieve adaptive therapy (AT)
Measured over Up to 5 years
Conditions
Where it's being run
1 sites across 1 statesArizona1
Study leadership
- Lida A. Mina, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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
What this trial measures
- Ability to achieve adaptive therapy (AT)Up to 5 years
Will be assessed by the proportion of patients (%) who are able to receive 2 or more cycles of AT with capecitabine divided by the total number of patients who have entered the AT phase of treatment (have stable or responsive disease).