NCT03324932进行中（未招募）3 期
A Multicenter, Randomized, Comparative Study Regarding the Efficacy of Denosumab on Normal Bone Mineral Density in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer (ENDEAVOR Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- percentage change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA)
研究概览
简要总结
This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density (BMD) in breast cancer patients with normal BMD. Investigators will compare the inhibitory effects of denosumab on bone loss between participants with normal BMD to whom Letrozole or Arimidex will be administered as postoperative endocrine therapy for stage I-IIIA postmenopausal hormone-sensitive breast cancer and controls.
详细描述
Normal BMD means T score is ≥-1.0 for the lumbar vertebrae (L1-L4) and/or the femoral neck.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following items at the time of case registration:
- •Patients with infiltrative breast cancer, aged ≥20 years, meeting the following definitions:
- •Those pathologically diagnosed with stage I, II, or IIIA breast cancer (Cancer Management Regulations, 11th version)
- •Those who underwent appropriate surgery, such as mastectomy and breast-preserving surgery
- •Estrogen receptor (ER)- or progesterone receptor (PgR)-positive patients on immunohistochemical (IHC) staining
- •Females meeting one of the following criteria for menopause:
- •Those, aged ≥55 years, without menstruation
- •Those, aged <55 years, with amenorrhea for ≥12 months, or those diagnosed with menopause by attending physicians based on the FSH and estradiol levels
- •Those who underwent bilateral oophorectomy
- •Patients in whom the BMD for the lumbar vertebrae (L1-L4) on DXA before the start of this study is ≥-1.0SD of the mean value of young adult females (YAM), and the BMD for the femoral neck is ≥-1.0SD of YAM
- •Patients without lumbar vertebral or femoral fracture
- •Those with an ECOG PS of 0-2
- •Those with adequate organ functions (laboratory data within 4 weeks before case registration)
- •Leukocyte count, ≥3,000/mm3 or Neutrophil count, ≥1,500/mm3
- •AST, ALT, ≤1.5-fold of the upper limit of the institutional reference range
- •Serum creatinine, ≤1.5-fold of the upper limit of the institutional reference range
- •Case registration should be performed before the following point:Twelve weeks after the completion of surgery or postoperative chemotherapy (The completion of chemotherapy refers to the completion of the final course, involving the recovery phase.)
- •Patients with an interval of ≥4 weeks after the discontinuation of therapy with bisphosphonates (oral preparations), estrogen preparations, raloxifene, calcitonin preparations, vitamin K preparations, active vitamin D preparations, or ipriflavone preparations, which influence bones
- •Those from whom written informed consent regarding study participation was obtained
排除标准
- •Whether each patient meets any of the following items must be checked on case registration:
- •Patients in whom distant metastasis was confirmed clinically or using imaging procedures at the time of case registration
- •Those with bilateral breast cancer
- •Those for whom postoperative hormonal therapy was started before consenting to study participation
- •Those who received endocrine therapy within 52 weeks before consenting to study participation
- •Those to whom bisphosphonate preparations were intravenously administered within 52 weeks before consenting to study participation
- •Those with the following diseases that may affect DXA
- •Severe scoliosis, immobility, hyperostosis or osteosclerosis of the lumbar vertebrae, calcification of the abdominal aorta, and vertebral disease
- •Those with a history of malignant tumors other than breast cancer within 260 weeks before consenting to study participation
- •Those with dental diseases, such as infectious diseases of the teeth or jaw and tooth trauma. Those for whom tooth or jaw surgery is scheduled within 6 weeks after consenting to study participation (tooth extraction, implantation)
- •Others who are considered to be ineligible by the chief investigator
研究组 & 干预措施
AI+denosumab VS only AI
Other
We compare AI intake+denosumab injection and AI intake only in patients with normal BMD to whom Letrozole or Arimidex will be administered as postoperative endocrine therapy, and we assess the efficacy of denosumab injection on bone loss by adjuvant endocrine therapy.
干预措施: Denosumab Injection (Drug)
结局指标
主要结局
percentage change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA)
时间窗: 12 months after the start of this study
The change is a value obtained by subtracting 1 from the BMD after 12 months/baseline BMD is expressed as a percentage
次要结局
- percentage change in the BMD for the lumbar vertebrae (L1-L4) on DXA(after 2, 3, 4, and 5 years)
- percentage change in the BMD for the femoral neck(after 12 months and 2/3/4/5 years)
- percentage change in the BMD for the radius (an ultrasonic bone densimeter is used)institutions in which ultrasonic bone densimeters are used)(after 2 and 4 weeks, every 4 weeks thereafter (for 2 years after registration)(only)
- Changes in Ca and bone metabolism markers(after 24 weeks)
- Appearance rate of morbid fracture in all participants(up to 3 years)
- Disease-free survival(at least 5 year)
- Overall survival(at least 5 year)
- Appearance of adverse events(at least 5 year)
- Quality of life (QOL)(after 24 weeks)
研究者
Hisako Ono, MD, PhD
Principal Invetstigator
Kyoto Prefectural University of Medicine
研究点 (1)
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