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

NCT07528768 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-04-14

No results posted yet for this study

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:

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • The University of The West Indies, Mona

    collaborator UNKNOWN

  • Kingston Public Hospital

    collaborator OTHER

  • AntiCancer Research Jamaica

    lead OTHER

Principal Investigators

  • Magdalene Nwokocha, DM, MBBS · University Hospital of the West Indies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2034-06-01
Completion
2034-06-01

Countries

  • Barbados
  • Jamaica
  • Trinidad and Tobago

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528768 on ClinicalTrials.gov