A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
研究概览
简要总结
This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months
详细描述
This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®) as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast cancer.
All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study will be performed for about 3 years and approximately 100 patients(actual target will be 80 treated patients) will be enrolled in about 10 investigational sites.
After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.
Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. The information of adverse events will be collected after the 1st dose of IP injection. In case that the evaluation of tumor response might be performed in regular clinical practice, those data will also be collected as well. The quality of life will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal status women
- •Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
- •Estrogen receptor positive
- •Radiographic progression of disease after the prior therapy
- •Patients who agree to participate in this study and sign the informed consent
排除标准
- •Patients who are treated with fulvestrant
- •Patients who are being treated with the other antitumor agents
- •Pregnancy or lactating women
- •History of hypersensitivity to any of included ingredients (eg. Castor oil)
- •Patients who are considered not fit for the study by investigators
- •Patients who have severe dysfunction of liver or kidney
研究组 & 干预措施
Single Arm
Faslodex treated in the study
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)
时间窗: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.
Percentage of patients with AEs.
次要结局
未报告次要终点