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

NCT07528768 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CREC-MN.013,2025/2026
• Study Type: interventional
• Target: 750
• Locations: 3 countries
• Sites: 3

Brief Summary

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:

• 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.

Conditions

Triple Negative Breast Cancer; Metastatic Triple-negative Breast Cancer

Keywords

Triple Negative Breast Neoplasms; Gemcitabine; Paclitaxel; Progression-Free Survival; Overall Survival; Quality of Life; Caribbean; Jamaica; Trinidad and Tobago; Barbados

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival (OS)

  Up to 5 years

• Quality of Life Score on EORTC QLQ-C30

  Up to 5 years

• Quality of Life Score on EORTC QLQ-BR23

  Up to 5 years

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

  Up to 5 years

Study Arms (2)

Intervention - Gemcitabine

EXPERIMENTAL

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)

Control - Paclitaxel

ACTIVE COMPARATOR

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

Interventions

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

Intervention - Gemcitabine

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

Control - Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellcome Trust: collaborator
• Kingston Public Hospital: collaborator
• AntiCancer Research Jamaica: lead
• The University of The West Indies, Mona: collaborator

Study Sites (3)

The Queen Elizabeth Hospital

Bridgetown, Saint Michael, Barbados

Location

The University of the West Indies, Mona

Mona, Kingston, Jamaica

Location

St. James Medical Complex

Port of Spain, Saint James, Trinidad and Tobago

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Magdalene Nwokocha, DM, MBBS

  University Hospital of the West Indies

  STUDY DIRECTOR

Central Study Contacts

Simone Badal, PhD

CONTACT

1-876-325-7366; simone.badal@uwi.edu

Alison E Ayoub, MSc

CONTACT

876-553-7242; alison.ayoub@uwi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: April 14, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning after publication of primary results and available for at least 5 years.
• 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.

Locations

TR (1); BA (1); JA (1)