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

Sponsor
AntiCancer Research Jamaica
Study ID
NCT07528768
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

First listed
Apr 14, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2034
Completion
Jun 1, 2034

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention - Gemcitabine
    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

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

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