NCT00321633已完成2 期
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
University College London Hospitals50 个研究点 分布在 6 个国家目标入组 148 人开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 50
- 主要终点
- Response and toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether carboplatin is more effective than docetaxel in treating patients with metastatic genetic breast cancer.
PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works compared to docetaxel in treating women with metastatic genetic breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the safety and effectiveness of carboplatin vs docetaxel in women with metastatic breast cancer and the BRCA1 or BRCA2 gene mutation.
Secondary
- Compare time to disease progression in patients treated with these regimens.
- Compare progression-free survival of patients treated with carboplatin vs docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •BRCA1 or BRCA2 mutation carrier
- •Metastatic disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •Stable, treated brain metastases allowed provided other sites of measurable disease are present
- •Patients with bone metastases who are currently receiving bisphosphonates for palliation are eligible provided other sites of measurable disease are present
- •Patients who have not received anthracycline-based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first-line metastatic treatment and enter the trial at confirmed progression (second-line)
- •No bone-limited disease
- •No disease suitable for endocrine therapy alone
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Sex: female
- •WHO performance status 0-2
- •Life expectancy ≥ 3 months
- •AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase > 5 times ULN)
- •Glomerular filtration rate ≥ 30 mL/min
- •Normal urea and creatinine
- •Normal hematological and biochemical studies
- •Normal bilirubin
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •Negative pregnancy test
- •No known allergy to platinum compounds or mannitol
- •No known sensitivity to taxanes
- •No other malignancy within the past 10 years except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
- •No sensory or motor neuropathy > grade 1
- •No other serious uncontrolled medical conditions or concurrent medical illness that would preclude study compliance
- •No contraindication to chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 12 months since prior taxane therapy
- •No prior chemotherapy with a platinum drug, unless treatment was for a non-breast cancer-related disease more than 10 years ago
排除标准
- 未提供
结局指标
主要结局
Response and toxicity
次要结局
- Time to progression
研究者
研究点 (50)
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