NCT03581552已完成不适用
A Pilot Study Examining Molecular and Clinical Effects of Aromatase Inhibitor Therapy on Skeletal Muscle Function in Early Stage Breast Cancer
Tarah J Ballinger, MD1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Changes in calstabin1 binding to RyR1 channels in skeletal muscle
研究概览
简要总结
This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Post-menopausal
- •Diagnosis of ductal carcinoma in situ (DCIS) or stage I, II, or III ER positive breast cancer
- •Plan to initiate an AI per treating physician.
- •Completion of all primary therapy for breast cancer, including surgery, radiation, and chemotherapy (should be completed 14 days or more prior to obtaining the baseline muscle biopsy). Ongoing HER2 targeted therapy with trastuzumab and/or pertuzumab is allowed. Ongoing neratinib therapy is not allowed.
- •Body weight less than 350 lbs., as dictated by the weight limit for DXA (dual energy x-ray absorptiometry) scanner
- •Must be willing to undergo muscle biopsy at baseline and after 24 weeks of AI therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of study enrollment
- •Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
排除标准
- •Unwilling to co-enroll into the FIT core study
- •Diagnosis of severe osteopenia or osteoporosis, defined as a bone mineral density of ≥ 2.0 standard deviations below the young adult female reference mean (T score)
- •Diagnosis of other disorder affecting bone function or turnover, such as Paget's disease, renal osteodystrophy, parathyroid disorders, or vitamin D deficiency/osteomalacia
- •Prior history of non-traumatic, fragility bone fracture
- •Any muscle or neuromuscular disorder affecting muscle function, such as muscular dystrophy, myositis, or amyotrophic lateral sclerosis
- •Any condition precluding power protocol participation (i.e. exertion on a stationary bicycle), including: New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator
- •Need for daily anticoagulation use
- •Allergy to local anesthetic
- •Locally recurrent or metastatic breast cancer a. History of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable.
结局指标
主要结局
Changes in calstabin1 binding to RyR1 channels in skeletal muscle
时间窗: through day 168 of aromatase inhibitor therapy
Changes in calstabin1 binding to RyR1 channels in skeletal muscle of breast cancer patients pre and post exposure to adjuvant aromatase inhibitor therapy
次要结局
- Relationship between markers of bone turnover and changes in muscle function(through day 168 of aromatase inhibitor therapy)
- Feasibility of repeated muscle biopsies in patients with early stage breast cancer initiating aromatase inhibitor therapy(through day 168 of aromatase inhibitor therapy)
- Relationship between changes in RyR1 biochemistry and measures of muscle function(through day 168 of aromatase inhibitor therapy)
- Relationship between markers of bone turnover and changes in RyR1 biochemistry(through day 168 of aromatase inhibitor therapy)
- Changes in ryanodine receptor/calcium release channel (RyR1) oxidation in skeletal muscle(through day 168 of aromatase inhibitor therapy)
- Characterize the timing of development of muscle dysfunction following initiation of aromatase inhibitor therapy(through day 168 of aromatase inhibitor therapy)
研究者
Tarah J Ballinger, MD
Assistant Professor of Clinical Medicine
Indiana University
研究点 (1)
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