A Randomized, Controlled, Open-Label Trial of Empiric Prophylactic vs. Delayed Use of Zoledronic Acid for Prevention of Bone Loss in Postmenopausal Women With Breast Cancer Initiating Therapy With Letrozole After Tamoxifen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 558
- 主要终点
- Average intra-patient change in total lumbar spine (L1-L4) bone mineral density (BMD) as measured by dual energy x-ray absorptiometry at baseline and 1 year after completion of study treatment
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss in patients who are receiving letrozole. It is not yet known which schedule of zoledronate is more effective in preventing bone loss in patients with breast cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of zoledronate to compare how well they work in preventing bone loss in postmenopausal women who are receiving letrozole for stage I, stage II, or stage IIIA breast cancer.
详细描述
OBJECTIVES:
- Compare the effectiveness of zoledronate vs standard care in reducing bone loss during the first 12 months of study treatment in postmenopausal women with stage I-IIIA breast cancer initiating letrozole after prior treatment with tamoxifen.
- Compare the effect of immediate vs delayed zoledronate, annually at 2-5 years post-baseline, in reducing bone loss in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to duration of prior tamoxifen therapy (≤ 2 years vs > 2 years); time since tamoxifen therapy was discontinued (< 1 vs ≥ 1 year); prior adjuvant chemotherapy (yes vs no); and baseline total lumbar spine or femoral neck bone mineral density (BMD) T-score (> -1 standard deviation [SD] vs between -1 to -2 SD). Patients are randomized to 1 of 2 treatment arms.
- Arm I (immediate therapy): Patients receive oral letrozole once daily. Patients also receive zoledronate IV over 15 minutes once every 6 months.
- Arm II (delayed therapy): Patients receive oral letrozole as in arm I. Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I.
In both arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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: letrozole + zoledronate
Patients receive oral letrozole once daily. Patients also receive zoledronate IV over 15 minutes once every 6 months.
Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
干预措施: letrozole (Drug)
Arm I: letrozole + zoledronate
Patients receive oral letrozole once daily. Patients also receive zoledronate IV over 15 minutes once every 6 months.
Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
干预措施: zoledronic acid (Drug)
Arm II: letrozole + zoledronate
Patients receive oral letrozole once daily. Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I.
Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
干预措施: letrozole (Drug)
Arm II: letrozole + zoledronate
Patients receive oral letrozole once daily. Patients with radiologic evidence of bone loss after 1 year of letrozole therapy receive zoledronate as in arm I.
Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Average intra-patient change in total lumbar spine (L1-L4) bone mineral density (BMD) as measured by dual energy x-ray absorptiometry at baseline and 1 year after completion of study treatment
时间窗: at 12 months
次要结局
- BMD (lumbar spine) annually for 5 years after completion of study treatment(Up to 5 years)
- Incidence of osteoporosis(Up to 5 years)
- Loss of bone density(Up to 5 years)
- Incidence of bone fractures(Up to 5 years)
- Time to disease progression(Up to 5 years)