A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 5
- 主要终点
- Change in Lumbar Density From Baseline to 12 Months
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.
详细描述
OBJECTIVES:
Primary
- The primary outcome of the study is the change in bone mineral density following a year on letrozole vs. a year on placebo.
Secondary
- Compare the safety, acceptability, and adherence to letrozole vs placebo in postmenopausal women at increased risk for the development or recurrence of breast cancer based on elevated plasma estradiol levels through evaluation of menopausal symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary effects), blood lipid levels, markers of bone turnover, and multidimensional quality of life.
- Determine the effect of letrozole-induced reduction of plasma estradiol levels on mammographic percent breast density.
- Obtain background information for a future large chemoprevention trial to address the question of whether a reduction in plasma estradiol levels can reduce the risk of breast cancer in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Letrozole
Participants in this arm received 2.5 mg of letrozole per day for a duration of 12 months; followed by an optional 4 years. Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
干预措施: Letrozole (Drug)
Placebo
Participants in this arm received 1 tablet per day which contained the inert ingredients from the letrozole tablet, for a duration of 12 months; followed by an optional 5 years of letrozole.Treatment continued in the absence of unacceptable toxicity or diagnosis of invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Lumbar Density From Baseline to 12 Months
时间窗: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Change in Hip Density From Baseline to 12 Months
时间窗: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Change in Femoral Neck Density From Baseline to 12 Months
时间窗: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
Change in Trochanter Density From Baseline to 12 Months
时间窗: Evaluation occurred at treatment initiation (BL) and after 12-months of treatment.
The bone mineral density (BMD) test was comprised of the following 4 measurements \[total density (g/cm\^2)\]: lumbar, femoral neck, trochanter, hip.
次要结局
- Worst Grade Muscle Aches/Pains(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Vomiting(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Headache(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Fatigue(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Hot Flashes(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Nausea(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Bone Pain(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
- Worst Grade Abdominal Pain(Heath assessments during treatment were administered at 3- and 9-months by telephone contact and during clinic visits at 6- and12-months.)
研究者
Judy E. Garber, MD
Garber, Judith MD
Dana-Farber Cancer Institute