A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant in Breast Ductal Carcinoma in Situ (DCIS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
研究概览
简要总结
The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases.
The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Postmenopausal women with newly diagnosed DCIS. Women will be considered to be in menopause if they fall into one of the following groups:
- •Age > 60
- •Age > 45 with amenorrhea > 1 year with intact uterus
- •Status post bilateral oophorectomies
- •FSH/estradiol levels in postmenopausal range for the institution
- •DCIS must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (Mammotome) or an equivalent method.
- •There must be available tissue from the diagnostic biopsy to perform molecular markers.
- •Baseline mammogram within 8 weeks of study entry.
- •Serum creatinine less than or equal to 2.0 mg/dl.
- •Total bilirubin less than or equal to 2.0 upper limit of normal (ULN), transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (ULN), AGC greater than or equal to 1500, platelets greater than or equal to 100,000, Hemoglobin greater than or equal to 8.0 g/dl
- •Peripheral neuropathy grade 0-
- •No prior therapy for DCIS.
- •SWOG performance status of less than or equal to 1
- •All patients must provide informed written consent
排除标准
- •Prior hormonal therapy (antiestrogens, estrogen, SERM's, progestins, or aromatase inhibitors) within 6 months of study entry.
- •Underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment.
- •History of DVT or Pulmonary Embolism
研究组 & 干预措施
3
Fulvestrant 250mg
干预措施: Fulvestrant (Drug)
2
Tamoxifen 20 mg
干预措施: Tamoxifen (Drug)
4
Fulvestrant 500mg IM
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment
时间窗: 6 months after treatment of last patient enrolled
Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.
次要结局
- Number of Participants With Changes in Mammographic Density(6 months after treatment of last patient enrolled)