A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,576
- 试验地点
- 39
- 主要终点
- Event-free Survival
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the event-free survival of postmenopausal women with receptor-positive primary breast cancer when treated with exemestane vs anastrozole.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the time to distant recurrence in patients treated with these regimens.
- Compare the incidence of new primary contralateral breast cancer in patients treated with these regimens.
- Compare the incidence of all clinical fractures, specifically hip and vertebral fractures, in patients treated with these regimens.
- Compare cardiovascular morbidity and mortality (i.e., significant coronary heart disease, which includes myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes, and all vascular deaths) in patients treated with these regimens.
- Correlate therapy induced changes in breast density with plasma hormones and growth factors, drug levels of exemestane and anastrozole, genetic variation and breast cancer recurrence or contralateral events in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 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
Exemestane
Patients receive oral exemestane (25 mg) once daily for 5 years.
干预措施: exemestane (Drug)
Anastrozole
Patients receive oral anastrozole (1 mg) once daily for 5 years.
干预措施: anastrozole (Drug)
结局指标
主要结局
Event-free Survival
时间窗: 5 years
Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.
次要结局
- Clinical Fracture Rate: Number of Participants With Bone Fractures.(8 years)
- Overall Survival: Percentage of Participants Alive at 5 Years(5 years)
- Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence(5 years)