A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,104
- 试验地点
- 734
- 主要终点
- Percentage of Patients Free From Breast Cancer
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
详细描述
OBJECTIVES:
- Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS).
- Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs.
- Compare quality of life and symptoms of patients treated with these drugs.*
- Compare quality-adjusted survival time of patients treated with these drugs.*
- Compare the occurrence of osteoporotic fractures in patients treated with these drugs.
- Compare disease-free and overall survival of patients treated with these drugs. NOTE: *The quality of life study closed to accrual as of 12/28/04.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).
- Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years.
- Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years.
Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.
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
- 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
tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years
干预措施: tamoxifen citrate (Drug)
Group 1
tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years
干预措施: Radiation Therapy (Radiation)
Group 2
anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years
干预措施: anastrozole (Drug)
Group 2
anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Percentage of Patients Free From Breast Cancer
时间窗: 10 years
Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.
次要结局
- Percentage of Patients Free From Non-breast Secondary Cancer(10 years)
- Percentage of Patients Free From Invasive Breast Cancer(10 years)
- Percentage of Patients Alive (Overall Survival)(10 years)
- Percentage of Patients Free From Ipsilateral Recurrence(10 years)
- Percentage of Patients Free From Contralateral Breast Cancer(10 years)
- Percentage of Patients Free From Osteoporotic Fractures(10 years)
- Percentage of Patients Alive and Disease-free(10 years)
- Quality of Life-Short Form 12 (SF-12) Physical Health Component Score(5 years)
- Quality-adjusted Survival Time(10 years)