Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06525766

Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer

Led by Mayo Clinic · Updated on 2026-05-11

35

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.

CONDITIONS

Official Title

Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed estrogen receptor positive, HER2-negative metastatic breast cancer
  • Measurable disease, including bone disease with measurable soft tissue component
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2
  • Hemoglobin level of at least 9.0 g/dL within 14 days prior to registration, with no recent transfusions
  • Absolute neutrophil count of at least 1500/mm3 within 14 days prior to registration
  • Platelet count of at least 100,000/mm3 within 14 days prior to registration
  • Total bilirubin level no greater than 1.5 times the upper limit of normal within 14 days prior to registration
  • Alanine aminotransferase and aspartate aminotransferase levels no greater than 3 times the upper limit of normal, or 5 times if liver involvement, within 14 days prior to registration
  • Prothrombin time, INR, and aPTT no greater than 1.5 times the upper limit of normal, or within therapeutic range if on anticoagulants, within 14 days prior to registration
  • Calculated creatinine clearance of at least 45 ml/min within 14 days prior to registration
  • Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
  • Ability to provide informed consent
  • Ability to complete questionnaires alone or with assistance
  • Willingness to provide mandatory blood samples for research
  • Ability to undergo CT scans as required
  • Willingness to return for follow-up visits at the enrolling institution
Not Eligible

You will not qualify if you...

  • Prior chemotherapy or antibody drug conjugate treatment for metastatic breast cancer
  • Pregnant, nursing, or unwilling 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 whole brain radiation or intervention
  • Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, uncontrolled arrhythmia, chronic oxygen dependence, respiratory failure, or psychiatric/social issues limiting compliance
  • Receiving other investigational treatments for the primary cancer
  • Active malignancy within 3 years, except non-melanotic skin cancer or cervical carcinoma in situ
  • Receiving other cancer treatments except approved antiestrogen therapies and bone-targeted agents
  • History of heart attack within 6 months or serious heart arrhythmias requiring maintenance therapy
  • Known complete deficiency of dihydropyrimidine dehydrogenase enzyme
  • History of severe allergic reaction to fluorouracil or capecitabine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

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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