NCT00172068终止2 期
Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Reduction of detected tumor cells in bone marrow
研究概览
简要总结
Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.
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
- •Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection
- •Evidence of minimal residual disease (disseminated tumor cells in bone marrow)
- •Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone
排除标准
- •Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case
- •Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy
- •Prior stem cell rescue/bone marrow transplant
- •History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix
- •Additional protocol-defined inclusion / exclusion criteria may apply
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Zoledronic acid + Calcium/Vitamin D (Drug)
Control Group
Active Comparator
干预措施: Zoledronic acid + Calcium/Vitamin D (Drug)
结局指标
主要结局
Reduction of detected tumor cells in bone marrow
时间窗: 12 months
次要结局
- Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).(24 months)
- Bone metastases-free survival(24 months)
- Disease-free survival(24 months)
- Bone mineral density(at 12 and 24 months)
- Number and localization of bone metastases(24 months)
研究者
研究点 (2)
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