A Phase II Study of Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant
研究概览
简要总结
The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.
详细描述
Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks.
Routine blood tests will be performed each time an injection is given.
Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis.
After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks.
Patients will continue to receive treatment as long as there is no disease progression or serious side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.
- •Tumors must be positive for estrogen receptors, progesterone receptors, or both.
- •Patients must be premenopausal.
- •Prior anti-estrogen therapy (with or without ovarian suppression)
- •Platelet count > 100,000/mm3
- •Age older than 18 years
- •ECOG performance status 0-2
排除标准
- •Hormonal treatment for metastatic disease
- •Pregnant or breast-feeding women
- •Postmenopausal
- •Concurrent hormonal therapy or chemotherapy
- •Prior fulvestrant therapy
- •More than three prior chemotherapy regimens for metastatic disease
- •Concurrent, long-term anticoagulation therapy
- •Severe, uncontrolled intercurrent illness
- •History of hypersensitivity to castor oil
结局指标
主要结局
To examine the clinical benefit and response rate of hormone receptor-positive metastatic breast cancer previously treated with anti-estrogen therapy in premenopausal women to treatment with fulvestrant
次要结局
- To determine the safety, time-to-progression, and duration of response for this patient population