Gemcitabine vs Paclitaxel in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer

Breaking Barriers in Breast Cancer Treatment for the Caribbean - Gemcitabine Versus Standard First-Line Chemotherapy in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer

The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in Black Caribbean women than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are Caribbean women of African ancestry, are 18 years or older, have had a biopsy that shows that they have triple negative breast cancer (TNBC), and are willing to take part.

The main questions the trial aims to answer are:

1. Does Gemcitabine stop triple negative breast cancer from growing or spreading better than Paclitaxel?
2. Are participants more likely to get better when taking Gemcitabine or Paclitaxel?
3. What medical problems do participants have when taking Gemcitabine for breast cancer?
4. Do Gemcitabine and Paclitaxel affect Black Caribbean women differently than women from other regions or ethnic groups?

To answer these questions, half of participants will be treated with Gemcitabine while half is treated with Paclitaxel. Both drugs are given by injection and have already been approved for breast cancer treatment. Participants will:

• Take Gemcitabine for two weeks followed by a two-week break, or take Paclitaxel once a week for the same time period.
• Have some of the cancer tissue that was tested from their biopsy taken for more testing.
• Have a physical exam and a blood test done every 3 weeks.
• Have images of their cancer taken using CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) every 6 weeks.
• Answer a brief questionnaire about how they are feeling every 8 weeks.
• Be checked on every month after treatment is finished to make sure the cancer hasn't come back.

Study Overview

• Status: Not yet recruiting
• Conditions: Triple Negative Breast Cancer; Metastatic Triple-negative Breast Cancer
• Intervention / Treatment: Drug: Gemcitabine (1000 mg/m^2); Drug: Paclitaxel 80 mg/m2 weekly

Detailed Description

This is a Phase II, randomized, open-label, multicentre clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for Caribbean 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 Trinidad and Tobago). 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.

Tumour 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.

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Simone Badal, PhD; Phone Number: 1-876-325-7366; Email: simone.badal@uwi.edu
• Study Contact Backup: Name: Alison E Ayoub, MSc; Phone Number: 876-553-7242; Email: alison.ayoub@uwi.edu

Study Locations

• Barbados
  • Saint Michael
    • Bridgetown, Saint Michael, Barbados
      • The Queen Elizabeth Hospital
      • Contact: Simon Anderson, PhD; Email: simon.anderson@cavehill.uwi.edu
• Jamaica
  • Kingston
    • Mona, Kingston, Jamaica
      • The University of the West Indies, Mona
      • Contact: Simone Badal, PhD; Phone Number: 876-325-7366; Email: simone.badal@uwi.edu
      • Contact: Alison E Ayoub, MSc; Phone Number: 8765537242; Email: alison.ayoub@uwi.edu
      • Sub-Investigator: Dwight Lowe, DM, MBBS
      • Sub-Investigator: Magdalene Nwokocha, DM, MBBS
      • Sub-Investigator: Derria Cornwall, DM, MBBS
      • Sub-Investigator: Patrick Roberts, DM, MBBS
      • Sub-Investigator: Rory Thompson, DM, MBBS
      • Sub-Investigator: Althea Bailey, PhD
• Trinidad and Tobago
  • Saint James
    • Port of Spain, Saint James, Trinidad and Tobago
      • St. James Medical Complex
      • Contact: Amalia Hoselin, PhD; Phone Number: 8687752895; Email: amalia.hosein@utt.edu.tt
      • Contact: Rajini Haraksingh, PhD; Phone Number: 85243 (868) 662-2002; Email: rajini.haraksingh@sta.uwi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Self-identified Caribbean Black women of Jamaican, Trinidadian, or Barbadian ancestry
2. Age ≥18 years
3. Histologically confirmed metastatic triple-negative breast cancer (recent biopsy required)
4. ECOG (Eastern Cooperative Oncology Group) performance status 0-1
5. No prior systemic therapy for metastatic disease
6. Adequate organ function (detailed laboratory criteria specified)
7. Written informed consent
8. Willingness to provide biospecimens for research

Exclusion Criteria:

1. Prior gemcitabine, anthracycline, or taxane treatment in any setting
2. Active brain metastases requiring immediate treatment
3. Pregnant or breastfeeding
4. Concurrent participation in other interventional trials
5. Medical conditions precluding safe chemotherapy administration
6. Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Gemcitabine; Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal	Drug: Gemcitabine (1000 mg/m^2); Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal
Active Comparator: Control - Paclitaxel; Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal	Drug: Paclitaxel 80 mg/m2 weekly; Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from randomization to death from any cause	Up to 5 years
Quality of Life Score on EORTC QLQ-C30	Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Covers 5 functional scales (Physical, Role, Cognitive, Emotional and Social), 3 symptom scales (Fatigue, Pain and Nausea/Vomiting) and a global health status scale. All are scored from 0 to 100 with higher scores corresponding to higher functioning or better quality of life on the functional and global health scales, and higher scores indicating greater severity of symptoms on the symptom scales.	Up to 5 years
Quality of Life Score on EORTC QLQ-BR23	Quality of life assessed using the EORTC Quality of Life Questionnaire breast cancer-specific module (QLQ-BR23). This includes 4 functional scales (Body Image, Future Perspective, Sexual Functioning and Sexual Enjoyment) 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms and Breast Symptoms). All scales are scored from 0 to 100, with a high score representing higher functioning/better quality of life on the functional scales and worse symptoms on the symptom scales.	Up to 5 years
Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0	Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).	Up to 5 years

Collaborators and Investigators

• Sponsor: AntiCancer Research Jamaica
• Collaborators: Wellcome Trust; Kingston Public Hospital; The University of The West Indies, Mona
• Investigators: Study Director: Magdalene Nwokocha, DM, MBBS, University Hospital of the West Indies

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gemcitabine; Quality of Life; Paclitaxel; Overall Survival; Triple Negative Breast Neoplasms; Progression-Free Survival; Jamaica; Caribbean; Barbados; Trinidad and Tobago
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Paclitaxel
• Other Study ID Numbers: CREC-MN.013,2025/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be made available after the conclusion of the study to researchers with approved proposals via email request. Data sharing will require a signed data use agreement and be determined on a case-by-case basis.
• IPD Sharing Time Frame: Beginning after publication of primary results and available for at least 5 years.
• IPD Sharing Access Criteria: Access will be provided to researchers with methodologically sound proposals, subject to approval by the study investigators and execution of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes