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HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry.

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Sponsor changed: AntiCancer Research Jamaica to The University of The West Indies Show 8 more changesShow less
    • Start date: Jun 1, 2026 to Jun 1, 2027
    • Interventions: Gemcitabine (1000 mg/m^2) (Drug), Paclitaxel 80 mg/m2 weekly (Drug) to Gemcitabine (1000 mg/m^2) (Drug), Paclitaxel 80 mg/m2 weekly (Drug)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study sites revised (3)
    • Collaborators: 3 to 4
    • Study title revised
    • Study description shortened, about 3 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 women of African ancestry than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are women of African ancestry, specifically from Jamaica, Barbados and Ghana, 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 women of African Ancestry 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.
Trial Details
NCT Number NCT07528768
Lead Sponsor The University of The West Indies
Collaborators: Wellcome Trust, Kingston Public Hospital, University of Ghana, AntiCancer Research Jamaica
Conditions
(from sponsor)
Triple Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov