Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of the alive patients without progress of the disease
研究概览
简要总结
This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.
详细描述
For patients affected by metastatic breast cancer RH+/HER2-, the conventional treatment is hormonotherapy. But, when patients don't react no recommendations exist.
Estramustine phosphate is currently prescribed for prostate cancer. The estramustine phosphate is an active anti-tumoral agent by oral route, associating a nitrogenous mustard with the estradiol, it settles on membrane receptor and the cytotoxic component acts essentially by dismantling microtubules inhibiting the mitosis.
Estramustine could be a therapeutic option when currently therapy are exhausted for patients reactive to hormonotherapy previous lines or chemotherapy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic breast cancer HER2-/RH+
- •Progression after hormonotherapy
- •Treated by taxanes, anthracyclines, capecitabine and eribulin
- •Treated by everolimus
- •Hematological Function: neutrophiles ≥ 1,5 x 109 / L, hemoglobin ≥ 9 g / dL, plaques ≥ 100 x 109 / L
- •Hepatic function: albumin ≥ 2,5 g / dl, bilirubin serum ≤ 2 x N (superior border of the standard) (unless disease of Gilbert), transaminases ≥ 3 x N
- •Renal Function: serum creatinine ≤ 1,5 mg / dL or clearance of the creatinine ≥ 40 mL / min
- •Estimated Life expectancy ≥ 3 months
排除标准
- •Hypersensitivity known about one of the constituents of the estramustine phosphates
- •Preliminary Treatment by estramustine phosphates
- •Brain Metastases
- •Patients not being under effective contraception
- •Minor, pregnant or lactating Patients
- •Patients not previously treated by everolimus
- •Transaminases > 3xN
- •Other concomitant anticancer treatment less than 1 month before the inclusion
- •Digestive function: malabsorption
- •History of other cancer in the previous 5 years (other than squamous-cell epithelioma or totally resected in situ carcinoma)
- •Active Thrombo-phlebitis
- •Risk thromboembolic known,
- •Unchecked cardiovascular Pathology
- •Grave hepatic Affection
研究组 & 干预措施
Estramustine
560 mg per day
干预措施: Estramustine (Drug)
Standard practice center
Standard treatment center choice.
Excepted: anthracyclines, taxanes, capecitabine and eribulin
干预措施: standard practice (Drug)
结局指标
主要结局
Proportion of the alive patients without progress of the disease
时间窗: 3 months
次要结局
- quality of life(18 months)
- progression-free survival(18 months)
- overall survival(18 months)