A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 122
- 主要终点
- Endometrial pathologic diagnosis
研究概览
简要总结
RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen.
PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.
详细描述
OBJECTIVES:
- Compare endometrial pathologic diagnoses (proliferative changes, simple or cystic hyperplasia, complex adenomatous hyperplasia, hyperplasia with atypia, and carcinoma) in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are randomly assigned to medroxyprogesterone acetate (MA) vs observation.
- Compare endometrial pathologic diagnoses (persistent endometrial hyperplasia, atypia, or carcinoma) resulting in tamoxifen discontinuation and intermittent bleeding in patients treated with these regimens.
- Characterize the incidence of spontaneous regression and progression of simple or cystic hyperplasia in these patients.
- Characterize endometrial biopsy results using different endometrial stripe width cut-off points, for cases in which the width is at least 5 mm by endovaginal ultrasound in patients receiving tamoxifen.
- Compare changes over time in endometrial oncogene expression (e.g., c-fos, c-jun, p53, IGF1) and receptor status in patients receiving tamoxifen with or without prior chemotherapy who are randomly assigned to MA vs observation.
- Describe the associations among change in gene expression, receptor status, endometrial abnormality, length of tamoxifen exposure, and prior chemotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to adjuvant chemotherapy (yes vs no), number of positive nodes (0-3 vs at least 4), and endovaginal sonogram endometrial stripe (less than 5 mm vs at least 5 mm). Patients are randomized to 1 of 2 arms.
All patients receive adjuvant oral tamoxifen daily for five years.
- Arm I: Patients undergo observation.
- Arm II: Patients receive oral medroxyprogesterone acetate on days 1-14. Treatment repeats every 3 months for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
Tamoxifen alone
Tamoxifen alone x 5 years
干预措施: tamoxifen citrate (Drug)
Tamoxifen alone
Tamoxifen alone x 5 years
干预措施: adjuvant therapy (Procedure)
Tamoxifen plus MPA
Tamoxifen Plus Medroxyprogesterone Acetate (MPA) x 5 years
干预措施: medroxyprogesterone (Drug)
Tamoxifen plus MPA
Tamoxifen Plus Medroxyprogesterone Acetate (MPA) x 5 years
干预措施: tamoxifen citrate (Drug)
Tamoxifen plus MPA
Tamoxifen Plus Medroxyprogesterone Acetate (MPA) x 5 years
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Endometrial pathologic diagnosis
时间窗: 2 years after registration
Endometrial pathologic diagnosis at 2 years after registration
次要结局
- Endometrial pathologic diagnosis(5 years after registration)