Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With ER/PR Positive Early Breast Cancer Who Are Using Adjuvant Letrozole
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.
研究概览
简要总结
The investigators will involve about 25 Patients of postmenopausal women who have ER/PR positive early breast cancer in each arm.
The study is a two-arm comparative, prospective, interventional, and randomized study. All patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients will receive ZOL immediately after randomization; delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment. All patients will receive daily supplements containing calcium (500 mg) and vitamin D (400-800 IU). Baseline bone mineral density and every 3 months will be done for the enrolled patients.
详细描述
The investigators will involve about 25 Patients of postmenopausal women who have ER/PR positive early breast cancer in each arm.
The study is a two-arm comparative, prospective, interventional, and randomized study. All patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients will receive ZOL immediately after randomization; delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment. All patients will receive daily supplements containing calcium (500 mg) and vitamin D (400-800 IU). Baseline bone mineral density and every 3 months will be done for the enrolled patients.
-Research outcome measures:
- Primary (main): The primary endpoint will be the percentage change in lumber spine (L2-L4) BMD at 12 months for immediate- versus delayed-ZOL patients.
- Secondary (subsidiary): Secondary end points will include percentage change in total hip BMD at each assessment, fracture incidence, time to disease recurrence (local relapse or distant metastasis), DFS, and safety.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic evidence of ER/PR positive breast adenocarcinoma
- •Postmenopausal women.
- •Baseline LS and total hip BMD T-score > -2.
- •No prior treatment with denosumab or IV bisphosphonates is allowed.
- •No prior treatment with radiopharmaceuticals.
- •Not pregnant and not nursing.
- •Good dental health.
- •ECOG performance status 0-
- •Calculated creatinine clearance >= 30 mL/min.
- •Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L)
排除标准
- •Patients with dental problems.
- •Patients with impaired renal functions
- •Patients with osteopenia, or T- score is below -2.0
- •Patients with history of serious drug hypersensitivity or drug allergy.
研究组 & 干预措施
Delayed use of zoledronic acid arm
delayed-ZOL patients will receive ZOL only if their T-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal X-ray at the 3- monthly assessment.
干预措施: Zoledronic Acid 4 MG (Drug)
Immediate use of zoledronic acid arm
Immediate-ZOL patients will receive ZOL immediately after randomization
干预措施: Zoledronic Acid 4 MG (Drug)
结局指标
主要结局
The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.
时间窗: 24 months
The percentage change in lumber spine (L2-L4) BMD at 12 and 24 months for immediate- versus delayed-ZOL patients.
次要结局
- percentage change in total hip BMD at each assessment, fracture incidence in percentage, time to disease recurrence in months (local relapse or distant metastasis), DFS in months, and safety.(24 months)
- Fracture incidence in percentage(24 months)
研究者
MAI MOHAMED HEMMAT ABDELFATAH ABDELGELIL
Assistant Lecturer of Clinical Oncology
Assiut University