A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,560
- 试验地点
- 76
- 主要终点
- Percentage of Women With Serious Adverse Events
研究概览
简要总结
RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen.
PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.
详细描述
OBJECTIVES:
Primary
Previously: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo.
Currently: To determine the frequency of serious adverse events for post-menopausal women at high-risk of developing breast cancer who choose to receive 5 years of exemestane as preventative therapy.
Secondary
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Exemestane
one 25 mg tablet daily in am
干预措施: exemestane (Drug)
结局指标
主要结局
Percentage of Women With Serious Adverse Events
时间窗: 5 years open-label extension period
Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.
Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)
时间窗: Over randomization period of study (median follow-up 35 months)
Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.
次要结局
- Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer(Over randomization period of study (median follow-up 35 months))
- Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events(Over randomization period of study (median follow-up 35 months))
- Number of Clinical Breast Biopsies(Over randomization period of study (median follow-up 35 months))
- Incidence of All Clinical Fractures(During protocol treatment over randomization period of study (up to 5 years))
- Incidence of Clinically Relevant Cardiac Events(During protocol treatment in randomization period (up to 5 years))
- Incidences of Other Malignancies(Over randomization period of study (median follow-up 35 months))