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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06105684
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine Pill — DRUG
    Will be given once per day by mouth

Study Details

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.

Key Dates

Start date
Feb 14, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low dose capecitabine (Xeloda)
    1000 mg capecitabine daily by mouth.

Primary Outcome Measure

Objective response rate (RR) evaluation [ Time Frame: Baseline up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Humaria Sarfraz, MD
[email protected]
205-975-2891
Katia Khoury, MD (SUB_INVESTIGATOR)
Humaria Sarfraz, MD (PRINCIPAL_INVESTIGATOR)
Mauricio Escobar, MD (SUB_INVESTIGATOR)
Nustrat Jahan, MD (SUB_INVESTIGATOR)
Gabrielle Rocque, MD (SUB_INVESTIGATOR)
Erica Stringer-Reasor, MD (SUB_INVESTIGATOR)
Allison Richard, MD (SUB_INVESTIGATOR)
Lisle Nabell, MD (SUB_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama at Birmingham· Birmingham, AL

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