The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 26
- 主要终点
- Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip
研究概览
简要总结
RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.
PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.
详细描述
OBJECTIVES:
- Determine whether there is a clinically relevant difference in bone mineral density (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27.
OUTLINE: This is a multicenter, companion study. Patients are stratified according to baseline bone mineral density (BMD) measurement (T-score* ≥ -2.0 standard deviation [SD] [no osteopenia or osteoporosis] vs T-score* < -2.0 SD).
NOTE: *The lowest of the two T-scores: L1-L4 or total hip
Blood samples for the identification of bone biomarkers (formation marker: serum amino-terminal procollagen 1 extension peptide [P1NP] and resorption marker: serum N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27
- •Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27
- •Hormone receptor status:
- •Estrogen receptor- and/or progesterone receptor-positive tumor
- •PATIENT CHARACTERISTICS:
- •Postmenopausal
- •No malabsorption syndrome
- •No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease
- •No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease
- •No other bone disease (including osteomalacia or osteogenesis imperfecta)
- •PRIOR CONCURRENT THERAPY:
- •More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I)
- •More than 12 months since prior and no concurrent anticonvulsants
- •More than 6 months since prior and no concurrent corticosteroids at doses > 5 mg/day of prednisone (or equivalent) for > 2 weeks
- •More than 12 months since prior and no concurrent anabolic steroids
- •No prior bisphosphonates (stratum II)
- •No concurrent sodium fluoride at daily doses ≥ 5 mg/day
- •No long-term (i.e., > 6 months) use of coumarins
- •No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis [stratum I])
排除标准
- 未提供
结局指标
主要结局
Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip
时间窗: 5 years
次要结局
- Clinical safety and tolerability of study medications(5 years)
- Percentage change in BMD at 5 years (from baseline)(5 years)
- Mean percentage change in BMD at 1, 3, and 5 years (from baseline)(5 years)
- Pattern of change in bone biomarkers from baseline(5 years)
- Proportion of patients without osteopenia or osteoporosis (stratum I) who develop BMD below the absolute threshold for osteopenia (< -2.0 standard deviation below the mean), suffer any osteoporotic fracture, or have an asymptomatic fracture revealed ...(5 years)
- Percentage of patients with osteopenia or osteoporosis (stratum II) who have ≥ 5% improvement of BMD at 2 years post randomization on protocol CAN-NCIC-MA27 and who have clinically apparent osteoporosis-related fracture of the long bones(5 years)