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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAntiCancer Research Jamaica

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Prior gemcitabine, anthracycline, or taxane treatment in any setting

Active brain metastases requiring immediate treatment

Pregnant or breastfeeding

Concurrent participation in other interventional trials

Trial design

Treatments tested in this trial

  • Gemcitabine (1000 mg/m^2)
  • Paclitaxel 80 mg/m2 weekly

Treatment groups

750 Participants
are divided into 2 treatment groups

Sponsors and collaborators

AntiCancer Research Jamaica

Lead sponsor

Wellcome Trust

Collaborator

The University of The West Indies

Collaborator

Kingston Public Hospital

Collaborator