This is a Phase II, randomized, open-label, multicenter clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for women of African ancestry with metastatic triple-negative breast cancer (TNBC).
Eligible participants will be randomized in a 1:1 ratio to one of two treatment arms, stratified by study site (5 major hospitals in Jamaica, Barbados and Ghana). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Participants assigned to the investigational arm will receive Gemcitabine administered on days 1 and 8 of a 21-day cycle. Participants assigned to the control arm will receive Paclitaxel administered weekly according to institutional standard practice.
Tumor assessments- via MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) as appropriate- will be conducted at regular intervals to evaluate disease status. Safety assessments (blood test panels) will occur throughout the study, and patient-reported outcomes will be collected using validated quality-of-life instruments.
Participants will be followed for progression, adverse events and survival outcomes for up to 12 months following treatment initiation. Data will be collected and managed using a secure, HIPAA-compliant electronic data capture system in compliance with HIPAA (Health Insurance Portability and Accountability Act). All analyses will be conducted using de-identified data.
