RANKL Inhibition and Breast Tissue Biomarkers in Premenopausal Women With Dense Breasts
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Effect of denosumab on breast tissue gene pathway gene expression
研究概览
简要总结
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal.
- •At least 35 years of age.
- •Dense breasts on routine mammogram.
- •Willing to take calcium (1,200mg) and vitamin D (800 IU) daily.
- •At increased risk for breast cancer using any of the following:
- •Positive family history of breast cancer
- •Breast cancer risk prediction models
- •Able and willing to return for repeat biopsy.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Current use of tamoxifen, aromatase inhibitors, or bisphosphonates.
- •Concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention).
- •Pregnant or lactating.
- •Recent tooth extraction or dental procedure.
- •Unhealed and/or planned dental/oral surgery.
- •History of osteonecrosis/osteomyelitis of the jaw.
- •History of osteoporosis or severe osteopenia.
- •Unable/unwilling to return for repeat biopsy.
研究组 & 干预措施
Denosumab
An ultrasound-guided core needle breast biopsy will be performed on day 1 prior to the intervention. A single dose of subcutaneous denosumab 60mg will be administered immediately after the core biopsy on day 1. This will take place on an outpatient basis. Repeat core-needle biopsy will take place on Day 60 (+/-10 days). Blood samples will also be collected at the time of core-needle biopsy to allow for biomarker assay. Gene expression analyses will be done using NanoString nCounter gene expression system.
干预措施: Ultrasound-guided core needle biopsy (Procedure)
Denosumab
An ultrasound-guided core needle breast biopsy will be performed on day 1 prior to the intervention. A single dose of subcutaneous denosumab 60mg will be administered immediately after the core biopsy on day 1. This will take place on an outpatient basis. Repeat core-needle biopsy will take place on Day 60 (+/-10 days). Blood samples will also be collected at the time of core-needle biopsy to allow for biomarker assay. Gene expression analyses will be done using NanoString nCounter gene expression system.
干预措施: Denosumab (Drug)
Denosumab
An ultrasound-guided core needle breast biopsy will be performed on day 1 prior to the intervention. A single dose of subcutaneous denosumab 60mg will be administered immediately after the core biopsy on day 1. This will take place on an outpatient basis. Repeat core-needle biopsy will take place on Day 60 (+/-10 days). Blood samples will also be collected at the time of core-needle biopsy to allow for biomarker assay. Gene expression analyses will be done using NanoString nCounter gene expression system.
干预措施: Blood draw (Procedure)
Denosumab
An ultrasound-guided core needle breast biopsy will be performed on day 1 prior to the intervention. A single dose of subcutaneous denosumab 60mg will be administered immediately after the core biopsy on day 1. This will take place on an outpatient basis. Repeat core-needle biopsy will take place on Day 60 (+/-10 days). Blood samples will also be collected at the time of core-needle biopsy to allow for biomarker assay. Gene expression analyses will be done using NanoString nCounter gene expression system.
干预措施: Calcium (Drug)
Denosumab
An ultrasound-guided core needle breast biopsy will be performed on day 1 prior to the intervention. A single dose of subcutaneous denosumab 60mg will be administered immediately after the core biopsy on day 1. This will take place on an outpatient basis. Repeat core-needle biopsy will take place on Day 60 (+/-10 days). Blood samples will also be collected at the time of core-needle biopsy to allow for biomarker assay. Gene expression analyses will be done using NanoString nCounter gene expression system.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Effect of denosumab on breast tissue gene pathway gene expression
时间窗: Between baseline and day 60
The investigators will evaluate changes in pathway gene expression between baseline and day 60 using NanoString NCounter platform
Effect of denosumab on pathways that may influence breast cancer development as measured by spatial transcriptomic analysis
时间窗: Between baseline and day 60
The investigators will evaluate changes in breast tissue spatial transcriptomics.
Effect of denosumab on pathways that may influence breast cancer development as measured by metabolomic analysis
时间窗: Between baseline and day 60
The investigators will evaluate changes in metabolomics.
次要结局
- Correlation of breast tissue gene expression with circulating biomarker levels(60 days)