NCT00072020Unknown3 期
Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer?
适应症
相关药物
试验速览
- 阶段
- 3 期
- 主要终点
- Disease-free survival as assessed annually for 10 years
研究概览
简要总结
RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy and/or hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.
PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone therapy together with zoledronate to see how well they work compared to chemotherapy and/or hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare disease-free survival of women with stage II or III breast cancer at high risk of relapse treated with neoadjuvant or adjuvant chemotherapy and/or hormonal therapy with vs without zoledronate.
Secondary
- Compare time to bone metastases, as first recurrence, in patients treated with these regimens.
- Compare time to bone metastases, per se, in patients treated with these regimens.
- Compare time to distant metastases in patients treated with these regimens.
- Compare overall survival in patients treated with these regimens.
- Compare the reduction in skeletal-related events (fractures, spinal cord compression, radiotherapy to the bone, surgery to the bone, and hypercalcemia) before and after the development of bone metastases in patients treated with these regimens.
- Determine the safety and toxicity of zoledronate in patients treated with these regimens.
- Correlate prognostic factors, such as estrogen-receptor and progesterone-receptor status, TNM stage, tumor grade, HER2/neu status, and menopausal status with treatment outcome in patients treated with these regimens.
- Determine more specific prognostic indicators for the development of bone metastases and factors that are able to predict specific benefit from bisphosphonate treatment using proteomics, tissue micro-array, and other modern techniques in these patients.
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
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease-free survival as assessed annually for 10 years
次要结局
- Time to bone metastases as first recurrence assessed annually for 10 years
- Time to bone metastases per se as assessed annually for 10 years
- Time to distant metastases as assessed annually for 10 years
- Overall survival as assessed by final analysis at 10 years
- Skeletal-related events prior to development of bone metastases as assessed annually for 10 years
- Skeletal-related events following development of bone metastases as assessed annually for 10 years
- Safety and toxicity of zoledronic acid as assessed annually for 10 years
- Evaluation of the influence of prognostic factors (e.g., estrogen receptor or progesterone receptor [ER/PR] status, TNM stage, tumor grade, HER2/neu, and menopausal status) on treatment outcome
- Analysis of tumor-specific mutations, proteomics and gene expression changes in tumor cells
研究者
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