Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.
研究概览
简要总结
The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Proven breast cancer
- •Metastatic or locally advanced breast cancer
- •Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)
- •Postmenopausal status
- •No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Adequate organ function
排除标准
- •No prior Exemestane or Fulvestrant
- •Uncontrolled intercurrent illness including but not limited to:
- •ongoing or active infection
- •symptomatic congestive heart failure
- •unstable angina pectoris
- •cardiac arrhythmia
- •myocardial infarction within the last 3 months
- •psychiatric illness/social situations that would limit compliance with study
- •Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
- •Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
研究组 & 干预措施
single-arm study
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
干预措施: Exemestane (Drug)
single-arm study
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.
时间窗: Every 2 cycles up to 2 years
TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)(Every 2 cycles, up to 1 year)
- Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant(Day 7 and Day 120)
- Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels(Prestudy, Day 7 and Day 120)