Actively Recruiting
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Led by University of Alabama at Birmingham · Updated on 2026-01-07
40
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed HER2 negative breast cancer
- Breast cancer subtypes eligible: hormone receptor positive or triple negative
- Metastatic or locally advanced breast cancer with at least one measurable lesion
- ECOG performance status of 0 to 2
- Progressed on at least one prior therapy in the metastatic setting
- Adequate organ function including specified blood counts and liver and kidney function
- Able to provide signed informed consent
- Female patients who are surgically sterile, postmenopausal, or using approved contraception methods
- Patients 60 years or older, or frail patients at any age as defined by investigator
- Complete initial work-up within two weeks prior to treatment start
- Patients with known HIV infection meeting inclusion criteria
You will not qualify if you...
- Prior treatment with capecitabine in the metastatic setting
- Only non-measurable disease present
- Severe liver failure (bilirubin > 3 times upper limit of normal) or renal failure (creatinine clearance < 30 mL/min)
- Unable to swallow pills
- HER2 positive breast cancer
- Major surgery within three weeks before study entry
- Untreated or unstable spinal cord compression
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
M
Margaret Thomas, MPH
CONTACT
K
Katia Khouri, MD
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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