NCT00172029已完成4 期
Study Comparing Full-dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment
研究概览
简要总结
The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.
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
- •Female patients aged ≥ 18 years.
- •Histologically confirmed diagnosis of breast cancer with at least one bone metastases.
- •Radiologically documented solitary or multiple osteolytic or osteoblastic lesions in axial skeleton or in the extremities in which radiotherapy is indicated.
- •Pain and/or analgesic score ≥ 3 (see section 3.5.2) at the bone site to be irradiated.
- •ECOG performance status ≤
- •Life expectancy more than 6 months.
排除标准
- •Patients in whom the target lesion(s) is not detectable by conventional techniques (i.e. X-rays MRI or CT scan).
- •Presence of pathological fracture in the target lesion(s).
- •Prior irradiation of the painful area(s) to be irradiated.
- •Known hypersensitivity to zoledronic acid or other biphosphonates.
- •Previous treatment with bisphosphonates for the current disease; any treatment with biphosphonates for other indications should anyway have been discontinued at least two years before randomization into the study.
- •Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
- •Change in anticancer therapy within the 2 weeks prior to screening assessments and/or test treatment start.
- •Patients with severe renal function (serum creatinine > 400 umol/l or > 4.5 mg/dl or calculated creatinine clearance ≤ 30 ml/minute) or with prior renal transplantation. Creatinine clearance will be calculated using the following formula:
- •Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (72) (serum creatinine [mg/dL]) or Creatinine clearance = (140-age[yr])(body weight [kg]) x 0.85 (0.814) (serum creatinine [µmol/L])
- •Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L).
- •Patients with clinically symptomatic brain metastases
- •Bone metabolism disorder, e.g. Paget disease, primary hyperparathyroidism
- •Serious intercurrent illness other than breast cancer that can interfere with the evaluation of the effect of the therapy.
- •Pregnancy and lactation.
- •Women of childbearing potential not on an effective form of contraception.
- •Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
- •Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
ZOL446 Standard radiotherapy dosage
Experimental
干预措施: Zoledronic acid (Drug)
ZOL446 Low radiotherapy dosage
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Percentage of patients showing complete response in bone pain palliation without having any analgesic treatment
时间窗: day 5, 12, 29; week 8, 12, 16, 20 & 24
次要结局
未报告次要终点
研究者
研究点 (1)
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