RecruitingPhase 2NCT06525766

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

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer


Sponsor

Mayo Clinic

Enrollment

35 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an "adaptive therapy" approach to using capecitabine (an oral chemotherapy pill) for metastatic breast cancer that is estrogen receptor-positive and HER2-negative. Instead of giving the maximum dose continuously, adaptive therapy adjusts the dose based on how the cancer is responding — the goal is to keep cancer cells in check longer rather than trying to eliminate them all at once. **You may be eligible if...** - You are 18 or older - You have confirmed ER-positive, HER2-negative metastatic breast cancer - You have not yet received chemotherapy or antibody-drug conjugate therapy for your metastatic disease - Your cancer is measurable on scans - Your blood counts, liver, and kidney function meet the required thresholds **You may NOT be eligible if...** - You have already had chemotherapy or antibody-drug conjugate therapy for metastatic breast cancer - You are pregnant, breastfeeding, or unwilling to use contraception - You have uncontrolled brain metastases or spinal cord compression - You have had a recent heart attack or uncontrolled heart arrhythmia - You have a known enzyme deficiency (DPYD) that makes capecitabine dangerous - You have had a severe allergic reaction to fluorouracil or capecitabine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

DRUGCapecitabine

Given PO

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

View Full Details on ClinicalTrials.gov

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NCT06525766


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