Phase III Randomized Study of Immediate Versus Luteal Phase Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 740
- 试验地点
- 9
- 主要终点
- Disease-free Survival
研究概览
简要总结
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at hospitals in Philippines, Vietnam, and Morocco.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Open for accrual in Asia only
- •Female age 18-50,
- •premenopausal with regular cycles (>25-35 in length)
- •fine-needle aspiration diagnosis
- •Stage II-IIIA hormone receptor positive invasive breast cancer
- •No prior radiation or chemotherapy
- •Must be surgical candidate for bilateral oophorectomy
排除标准
- 未提供
研究组 & 干预措施
Immediate surgery
Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen
干预措施: Tamoxifen (Drug)
Scheduled surgery
Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen
干预措施: Tamoxifen (Drug)
Immediate Surgery - nonrandomized
Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: two- to three-year accrual and initial two or more years of follow-up period
5-year disease-free survival
次要结局
未报告次要终点