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NCT Number: NCT07528768

Gemcitabine vs Paclitaxel 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.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Metastatic Triple-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Queen Elizabeth Hospital, Bridgetown, Saint Michael, Barbados

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gemcitabine (1000 mg/m^2)

Drug

Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal

Paclitaxel 80 mg/m2 weekly

Drug

Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 5 years

    Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 years

    Time from randomization to death from any cause

  2. Quality of Life Score on EORTC QLQ-C30

    Time frame: Up to 5 years

    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.

  3. Quality of Life Score on EORTC QLQ-BR23

    Time frame: Up to 5 years

    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.

  4. Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0

    Time frame: Up to 5 years

    Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

Study contacts

Contact information is provided by the study sponsor or research team.

Alison E Ayoub, MSc

CONTACT

[email protected]

876-553-7242

Simone Badal, PhD

CONTACT

[email protected]

1-876-325-7366

Sponsors and collaborators

Lead sponsor

AntiCancer Research Jamaica

Other

Collaborators

  • Kingston Public Hospital
  • The University of The West Indies
  • Wellcome Trust

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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