Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Time to first bone metastases
研究概览
简要总结
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
详细描述
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.
Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed:
- quality of life,
- performance status,
- pain rating,
- analgesic administration and
- adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age >= 18 years old.
- •Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
- •Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.
- •A maximum of two chemotherapy lines for metastatic disease.
- •A maximum of two hormone therapy lines for metastatic disease.
- •Normal, minimally altered renal function (serum creatinine < 1.5 x Upper Normal Limit (UNL)).
- •Normal serum calcium levels.
- •Performance status 0,1 (World Health Organization (WHO)).
- •Negative pregnancy test before study recruitment.
排除标准
- •Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.
- •Metastasis in CNS.
- •History of hypersensitivity to bisphosphonates.
- •Pregnant or lactating women.
- •Third chemotherapy line for metastatic disease.
- •Third hormone therapy line for metastatic disease.
研究组 & 干预措施
Arm A: Zoledronic acid 4 mg
Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Time to first bone metastases
时间窗: Up to disease progression
The main variable of evaluation is the time until the appearance of first bone metastases.
次要结局
- The Number of Participants Who Experienced Adverse Events (AE)(Through study treatment)
- Quality of life per treatment arm(Up to disease progression)