Actively Recruiting
Adaptive Therapy With Capecitabine for Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer Treatment
Led by Mayo Clinic · Updated on 2026-05-11
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of adaptive therapy with capecitabine in patients with metastatic breast cancer that is estrogen receptor positive and HER2 negative. This phase II trial aims to assess whether adjusting the dose of capecitabine based on tumor response, measured through imaging and tumor markers, is feasible and can impact disease progression and overall survival. The study also explores quality of life, adverse events, and genetic markers related to treatment response and resistance. During the initial phase, patients receive standard doses of capecitabine orally twice daily for two weeks in 21-day cycles. Those whose cancer responds or remains stable after two cycles enter the adaptive phase, where the dose is reduced by 50% and adjusted based on disease burden measured by CT scans and blood tests every cycle. Dose changes include further reductions or increases of 50% depending on tumor response, with ongoing monitoring including blood samples, imaging, and bone scans. Participants will undergo regular assessments including blood tests, CT or MRI scans, and bone scans as needed. Quality of life questionnaires are completed to track patient well-being. After treatment, patients are followed up every three months for up to three years. Primary outcomes focus on the ability to achieve adaptive therapy modifications, with secondary measures tracking time to progression, survival, cumulative drug dose, adverse events, and quality of life.
CONDITIONS
Brief Title
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of estrogen receptor positive, HER2 negative metastatic breast cancer
- Measurable disease, including bone disease with measurable soft tissue component
- ECOG performance status of 0, 1, or 2
- Hemoglobin level at least 9.0 g/dL within 14 days before registration without recent transfusions
- Absolute neutrophil count at least 1500/mm^3 within 14 days before registration
- Platelet count at least 100,000/mm^3 within 14 days before registration
- Total bilirubin no more than 1.5 times the upper limit of normal within 14 days before registration
- ALT and AST no more than 3 times upper limit of normal (or up to 5 times if liver involved) within 14 days before registration
- Prothrombin time, INR, and aPTT within 1.5 times upper limit of normal or within target range if on anticoagulants within 14 days before registration
- Creatinine clearance at least 45 ml/min using Cockcroft-Gault formula within 14 days before registration
- Negative pregnancy test within 7 days before registration for persons of childbearing potential
- Ability to provide informed consent
- Ability to complete questionnaires independently or with help
- Willingness to provide blood samples for research
- Ability to undergo re-staging CT scans as required
- Willingness to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Prior chemotherapy or antibody drug conjugate treatment in the metastatic setting
- Pregnancy, nursing, or unwillingness to use adequate contraception if of childbearing potential
- Major surgery within 3 weeks prior to registration
- Radiation therapy within 2 weeks prior to registration
- Evidence of visceral crisis or impending spinal cord compression
- Uncontrolled brain metastases requiring treatment
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, chronic oxygen dependence, respiratory failure, or psychiatric/social issues limiting compliance
- Receiving other investigational agents for primary cancer
- Other active malignancy within 3 years except non-melanotic skin cancer or carcinoma in situ of cervix
- History of myocardial infarction within 6 months or life-threatening ventricular arrhythmias requiring ongoing therapy
- Known genetic variants causing complete absence of dihydropyrimidine dehydrogenase activity
- History of severe allergic reaction to fluorouracil or capecitabine
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 screening and enrollment visit
Duration - At least 2 cycles of 21 days each
Participants receive standard dose capecitabine orally twice daily on days 1-14 of each 21-day cycle. Those with disease response or stability after 2 cycles proceed to the adaptive phase.
Visits every 21 days for treatment and assessments
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive a 50% reduced dose of capecitabine orally twice daily on days 1-14 of each 21-day cycle. Dose adjustments occur based on disease burden assessed by blood samples every cycle and CT scans every other cycle.
Blood sample collection every cycle and CT scans every other cycle
Duration - Up to 3 years
After completing study treatment, participants are followed every 3 months for up to 3 years to monitor health and outcomes.
Visits every 3 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
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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