Phase II Study of Low-Dose Capecitabine for Advanced Breast Cancer

This study is testing a lower dose of Capecitabine, a chemotherapy pill, for women with advanced breast cancer that has spread (metastatic breast cancer). It's for those aged 60 or older, or younger patients who are frail and might have more difficulty with other treatments. To join, your breast cancer must be HER2-negative, meaning it doesn't have too much of a protein called HER2. The main goal is to see how many patients respond to the treatment, which will be checked over about 12 weeks. This study is currently recruiting 40 participants.

Study design
This is a Phase II, single-arm study, meaning all 40 participants will receive the study drug, Capecitabine. It is not specified if the study is open-label or blinded.
What's involved
You would take Capecitabine pills once daily by mouth. The study will continue until your disease progresses or if you experience unacceptable side effects.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, objective response rate, will be evaluated from baseline up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06105684

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

Recruiting
PHASE2Ages 60+InterventionalTreatment
University of Alabama at Birmingham
~40 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Capecitabine Pill

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (RR) evaluation
Measured over Baseline up to 12 weeks
Metastatic Breast Cancer
1 sites across 1 states
Alabama1
  • Humaria Sarfraz, MD · PRINCIPAL_INVESTIGATOR · The University of Alabama at Birmingham

Opens a ready-to-send draft in your own email app — review before sending.

  • Objective response rate (RR) evaluationBaseline up to 12 weeks

    Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression of disease will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee; version 1.1. Patients will be evaluated for response every 12 weeks per RECIST Criteria.