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Aromatase Inhibitor Host Factors Study

2021年5月12日 更新者：Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Patient-related Predictors of Estrogen Suppression in Postmenopausal Women Using Adjuvant Letrozole

The purpose of this study is to examine how key patient factors, including body size affect how well letrozole suppresses circulating estrogen levels.

This study has two components: (1) Part A - an observational phase to evaluate the impact of vitamin D and obesity on estrogen suppression in post-menopausal women already receiving letrozole treatment, and (2) Part B - an interventional phase for women with body mass index (BMI) > 25 kg/m2 to assess the effect of double AI dose on estrogen levels.

If BMI or other patient factors reduce the effectiveness of letrozole, modifications to treatment recommendations and studies to test higher dosing of letrozole may be needed to maximize the benefit of this treatment and minimize the risk of the breast cancer coming back.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The available evidence suggests that circulating estradiol levels play a critical role in determining effectiveness of aromatase inhibitor therapy, and that maximal suppression of aromatase activity and estrogen production is essential for optimal disease control. Host factors such as high 25-Hydroxy Vitamin D (25-OH D) levels and obesity, which might increase residual estrogen levels, could adversely impact outcome and lead to an increased risk of recurrence or death. The primary objective of Part A (which includes women regardless of BMI) is to directly evaluate the relationship between (i) 25-OH D levels and serum estrogen levels and (ii) BMI and serum estrogen levels in a cohort of postmenopausal women on standard dose letrozole therapy (2.5 mg/day). Part B (which includes only women with BMI > 25 kg/m2) will determine whether an increased dose of letrozole (5 mg/day), which had no dose limiting side effects in a Phase I study improves suppression of estrogen in overweight/obese women.

研究类型

介入性

注册 (实际的)

121

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 1X5
        • Mount Sinai Hospital
      • Toronto、Ontario、加拿大、M5G 1M9
        • Princess Margaret Hospital
      • Toronto、Ontario、加拿大、M5S 1B1
        • Women's College Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Postmenopausal female patients
  • histological confirmed diagnosis of estrogen receptor and/or progesterone receptor positive breast cancer (Stage I-III) who have completed local therapy
  • Currently prescribed and taking letrozole 2.5 mg daily for a minimum of 3 months
  • Willing to provide written informed consent to participate
  • for the experimental arm: all of the above and body mass index (BMI) > 25 kg/m2

Exclusion Criteria:

  • Known abnormal liver or renal function defined by:

    1. Serum Creatinine > 1.25 times institutional upper limit of normal (ULN) or Calculated Creatinine Clearance < 40 mL/min
    2. Serum Bilirubin, Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times ULN
  • Presence of persistent local or known metastatic cancer

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Post-menopausal Women Using Adjuvant Letrozole
Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants
药品：Letrozole
Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.
其他名称：
  • 费马拉

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part A Correlation of Day 29 Estradiol With BMI
大体时间：Day 29
Determine if estradiol levels vary with BMI levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estradiol and log-transformed BMI
Day 29
Part A Correlation of Day 29 Estrone With BMI
大体时间：Day 29
Determine if estrone levels vary with BMI levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estrone and log-transformed BMI
Day 29
Part A Correlation of Day 29 Estradiol With Vitamin D
大体时间：Day 29
Determine if estradiol levels vary with Vitamin D levels levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estradiol and log-transformed Vitamin D level
Day 29
Part A Correlation of Day 29 Estrone With Vitamin D
大体时间：Day 29
Determine if estrone levels vary with Vitamin D levels levels after 28 days of monitored adherence to standard dose letrozole, by calculating the Pearson correlation between estrone and log-transformed Vitamin D level
Day 29
Part B Change in Estradiol Level After Double Dose of Letrozole
大体时间：Day 29 to Day 58
In overweight/obese patients enrolled in part B, determine if blood levels of estradiol levels changed from before to after the double dose of letrozole
Day 29 to Day 58

次要结果测量

结果测量
措施说明
大体时间
Plasma Letrozole
大体时间：Day 29 and day 58
Day 29 and day 58
Endocrine Symptoms During Part A of Study
大体时间：baseline, day 29 (end of part A)
Functional Assessment of Cancer Therapy - Endocrine Sub-scale (FACT-ES) consists of 19 questions answered of a Likert scale. The sub-scale score ranges from 0 to 76 and the higher the score the better the quality of life
baseline, day 29 (end of part A)
Endocrine Symptoms During Part B of the Study
大体时间：day 29 (end of part A) and day 58 (end of part B)
Functional Assessment of Cancer Therapy - Endocrine Sub-scale (FACT-ES) consists of 19 questions answered of a Likert scale. The sub-scale score ranges from 0 to 76 and the higher the score the better the quality of life
day 29 (end of part A) and day 58 (end of part B)

其他结果措施

结果测量
大体时间
Musculoskeletal Symptoms
大体时间：baseline (day 1), day 29 (end of part A) and day 58 (end of part B)
baseline (day 1), day 29 (end of part A) and day 58 (end of part B)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

调查人员

  • 首席研究员：Srikala Sridhar, M.D.、Princess Margaret Hospital, Canada

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年10月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2012年8月15日

首先提交符合 QC 标准的

2012年8月16日

首次发布 (估计)

2012年8月21日

研究记录更新

最后更新发布 (实际的)

2021年5月13日

上次提交的符合 QC 标准的更新

2021年5月12日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AI Host Factors

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data supporting the related manuscript are kept in institutional file storage on an internal server at Lunenfeld-Tanenbaum Research Institute. There are de-identification concerns in small, regionally restricted, clinical datasets which prevent these data being openly available, but data will be made available at reasonable request from the corresponding author for up to and including 5 years from publication of the related manuscript.

For all data requests please contact:

Dr David Cescon, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. Dave.Cescon@uhn.ca

IPD 共享时间框架

Up to and including 5 years from publication of the related manuscript (Elliott, Mitchell J et al. "Association between BMI, vitamin D, and estrogen levels in postmenopausal women using adjuvant letrozole: a prospective study." NPJ breast cancer vol. 6 22. 12 Jun. 2020)

IPD 共享访问标准

Reasonable request

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Letrozole的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Mongolia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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