RecruitingPhase 2NCT06105684

Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer


Sponsor

University of Alabama at Birmingham

Enrollment

40 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.


Eligibility

Sex: FEMALEMin Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial is testing whether low-dose capecitabine (an oral chemotherapy pill) is effective in women with advanced HER2-negative breast cancer — including both hormone receptor-positive and triple-negative subtypes — who have already received at least one prior treatment. **You may be eligible if...** - You are a woman with confirmed breast cancer that is HER2-negative - Your cancer is metastatic or locally advanced with at least one measurable tumor - You have received at least one prior treatment (hormone therapy or chemotherapy) for metastatic disease - Your overall health is adequate (ECOG 0–2) - Your blood counts, liver, and kidney function meet minimum thresholds **You may NOT be eligible if...** - You have HER2-positive breast cancer - Your creatinine clearance is below 30 mL/min (significant kidney impairment) - You are male - You are pregnant or breastfeeding - You have had prior treatment with capecitabine or fluorouracil that caused serious side effects 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

DRUGCapecitabine Pill

Will be given once per day by mouth


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT06105684


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