Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9,779
- 试验地点
- 1
- 主要终点
- Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years
研究概览
简要总结
To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.
This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
- •Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.
排除标准
- •Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
- •Inflammatory breast cancer
- •Histologically positive supraclavicular nodes
- •Ulceration/infiltration of local skin metastasis
- •Neoadjuvant chemotherapy
- •Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
- •ER and PR negative primary tumor or ER/PR unknown status.
研究组 & 干预措施
exemestane
干预措施: exemestane (Aromasin) (Drug)
tamoxifen + exemestane
干预措施: tamoxifen + exemestane (Drug)
结局指标
主要结局
Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years
时间窗: Baseline (Month 0) up to 2.75 years
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years
时间窗: Baseline (Month 0) up to 5 years
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
次要结局
- Number of Events for Overall Survival (OS)(Baseline (Month 0) up to 5 years)
- Time to New Primary Breast Cancers(Baseline (Month 0) up to 5 years)
- Number of Events for Time to Relapse(Baseline (Month 0) up to 5 years)
- Number of Participants With New Primary Non-breast Cancers(Baseline (Month 0) up to 5 years)