Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,097
- 主要终点
- Disease-free Survival
研究概览
简要总结
RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
- Compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate.
- Compare the distributions of sites of first disease recurrence in patients treated with these drugs.
- Compare adverse events in patients treated with these drugs.
- Correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients treated with these drugs.
- Investigate whether there is an association between inherited germ-line single nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate synthase (FDPS) and the adverse event of acute phase reactions in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
- Arm II: Patients receive oral clodronate once daily for 35 months.
- Arm III: Patients receive oral ibandronate once daily for 35 months. Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months until disease recurrence and then annually for up to 10 years.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years.
干预措施: zoledronic acid (Drug)
Arm II
Patients receive oral clodronate once daily for 35 months.
干预措施: clodronate disodium (Drug)
Arm III
Patients receive oral ibandronate once daily for 35 months.
干预措施: ibandronate sodium (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence
Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.
次要结局
- Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs(Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.)
- Overall Survival(follow up completed every 6 months for 5 years and then annually for 5 years or until death)
- Distributions of Sites of First Recurrence on the Three Arms.(Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence)