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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Gemcitabine (1000 mg/m^2)
DrugGemcitabine 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
DrugPaclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall Survival (OS)
Time from randomization to death from any cause
Quality of Life Score on EORTC QLQ-C30
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Covers 5 functional scales (Physical, Role, Cognitive, Emotional and Social), 3 symptom scales (Fatigue, Pain and Nausea/Vomiting) and a global health status scale. All are scored from 0 to 100 with higher scores corresponding to higher functioning or better quality of life on the functional and global health scales, and higher scores indicating greater severity of symptoms on the symptom scales.
Quality of Life Score on EORTC QLQ-BR23
Quality of life assessed using the EORTC Quality of Life Questionnaire breast cancer-specific module (QLQ-BR23). This includes 4 functional scales (Body Image, Future Perspective, Sexual Functioning and Sexual Enjoyment) 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms and Breast Symptoms). All scales are scored from 0 to 100, with a high score representing higher functioning/better quality of life on the functional scales and worse symptoms on the symptom scales.
Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0
Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Sponsors and contacts
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AntiCancer Research Jamaica
Lead sponsor
Wellcome Trust
Collaborator
The University of The West Indies
Collaborator
Kingston Public Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: