A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,598
- 试验地点
- 162
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
详细描述
OBJECTIVES:
- Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer.
- Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients.
- Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients.
- Evaluate the quality of life of a subset of these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral exemestane daily for 5 years.
- Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years.
Quality of life is assessed at baseline and then every 6 months for 5.5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（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
Group 1
Exemestane
干预措施: exemestane (Drug)
Group 2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Disease-free survival
时间窗: Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.
次要结局
- Overall survival(Death from any cause)
- Time to treatment failure(time from randomization to recurrence or contralateral second primary cancer)
- Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement(measurements taken at regular intervals from randomization through 6 years following randomiztion)