Breaking Barriers in Breast Cancer Treatment for the Caribbean - Gemcitabine Versus Standard First-Line Chemotherapy in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- AntiCancer Research Jamaica
- 入组人数
- 750
- 试验地点
- 3
- 主要终点
- Progression-Free Survival (PFS)
概览
简要总结
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:
- Does Gemcitabine stop triple negative breast cancer from growing or spreading better than Paclitaxel?
- Are participants more likely to get better when taking Gemcitabine or Paclitaxel?
- What medical problems do participants have when taking Gemcitabine for breast cancer?
- 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.
详细描述
This is a Phase II, randomized, open-label, multicentre clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for Caribbean women of African ancestry with metastatic triple-negative breast cancer (TNBC).
Eligible participants will be randomized in a 1:1 ratio to one of two treatment arms, stratified by study site (5 major hospitals in Jamaica, Barbados and Trinidad and Tobago). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Participants assigned to the investigational arm will receive Gemcitabine administered on days 1 and 8 of a 21-day cycle. Participants assigned to the control arm will receive Paclitaxel administered weekly according to institutional standard practice.
Tumour assessments- via MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) as appropriate- will be conducted at regular intervals to evaluate disease status. Safety assessments (blood test panels) will occur throughout the study, and patient-reported outcomes will be collected using validated quality-of-life instruments.
Participants will be followed for progression, adverse events and survival outcomes for up to 12 months following treatment initiation. Data will be collected and managed using a secure, HIPAA-compliant electronic data capture system in compliance with HIPAA (Health Insurance Portability and Accountability Act). All analyses will be conducted using de-identified data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •No prior systemic therapy for metastatic disease
- •Adequate organ function (detailed laboratory criteria specified)
- •Written informed consent
- •Willingness to provide biospecimens for research
排除标准
- •Prior gemcitabine, anthracycline, or taxane treatment in any setting
- •Active brain metastases requiring immediate treatment
- •Pregnant or breastfeeding
- •Concurrent participation in other interventional trials
- •Medical conditions precluding safe chemotherapy administration
- •Inability to provide informed consent
研究组 & 干预措施
Intervention - Gemcitabine
Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal
干预措施: Gemcitabine (1000 mg/m^2) (Drug)
Control - Paclitaxel
Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal
干预措施: Paclitaxel 80 mg/m2 weekly (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 5 years
Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first.
次要结局
- Overall Survival (OS)(Up to 5 years)
- Quality of Life Score on EORTC QLQ-C30(Up to 5 years)
- Quality of Life Score on EORTC QLQ-BR23(Up to 5 years)
- Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0(Up to 5 years)
研究者
Simone Badal
Principal Investigator
AntiCancer Research Jamaica