Efficacy and Tolerability of Toremifene or Tamoxifen Therapy in Premenopausal Estrogen and Progesterone Receptor Positive Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 3,036
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
In premenopausal women, endocrine adjuvant therapy for breast cancer primarily consists of tamoxifen alone or with ovarian suppressive strategies. Toremifene is a chlorinated derivative of tamoxifen, but with a superior risk-benefit profile. In this trial, we sought to compare the efficacy and tolerability of toremifene and tamoxifen therapy in premenopausal patients with operable,estrogen and/or progesterone receptor positive breast cancer patients.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Breast cancer
- •Received standard treatment (chemotherapy, operation, or radiotherapy)
- •premenopausal
- •estrogen and/or progesterone receptor positive
排除标准
- •Metastatic tumors
- •During pregnancy or lactation
研究组 & 干预措施
tamoxifen
tamoxifen,20mg/day
干预措施: toremifene or tamoxifen (Drug)
toremifene
toremifene,60mg/day
干预措施: toremifene or tamoxifen (Drug)
结局指标
主要结局
5-year overall survival
时间窗: up to 5 years
survival outcomes: disease free survival
时间窗: up to 5 years
次要结局
- side effects effects of therapies(Follow-up period,up to 5 years)
- Incidence of adverse events(follow-up period, up to 5 years)
研究者
Fengxi Su
Chief of Breast cancer center in Sun Yat-Sen Memorial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University