Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Measurement of Gene Expression in Breast Epithelial Cells Obtained for Asymptomatic High Breast Cancer Risk Nulliparous Premenopausal Women at Baseline, After Treatment With r-hCG at 90 Days, and at 270 Days From Baseline
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in preventing breast cancer in premenopausal women with BRCA1 mutations.
详细描述
OBJECTIVES:
Primary
- Determine whether the genomic profiles of breast epithelial cells of high-breast cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition, express a signature indicative of high-risk.
Secondary
- Determine whether women identified to express a "high-breast cancer-risk" signature will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which should have induced breast differentiation and genomic changes that would serve as biomarkers indicative of decreased breast cancer risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Asymptomatic women who have a deleterious mutation on the BRCA1 gene
- •Normal, no complaints, no evidence of disease
- •Nulliparous, never pregnant (G0P0)
- •No previous diagnosis of breast or ovarian cancer
- •No known brain metastases
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-1 OR Karnofsky PS 90-100%
- •Premenopausal with normal menstrual cycles and intact ovaries
- •Normal ovarian size report from pelvic ultrasound
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to human chorionic gonadotropin preparations or one of its excipients
- •No uncontrolled intercurrent illness including any of the following:
- •Ovarian enlargement of undetermined origin
- •Ovarian cysts > 2 cm
- •Microcystic ovaries, which might predispose to the development of ovarian hyperstimulation syndrome
- •History of prior cancer other than non-melanoma skin cancer
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Severe cognitive deficit or psychiatric illness/social situations that would make her unable to give informed consent or would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •At least 6 weeks since prior and no concurrent oral contraceptives or hormone-replacement therapy
- •No concurrent tamoxifen for chemoprevention
- •No concurrent participation in another chemopreventive trial for breast cancer
- •No concurrent medication that could interfere with this study including any of the following:
- •Hormonal contraceptives
- •Androgens
- •Prednisone
- •Thyroid hormones
- •No other concurrent investigational agents
- •No recent treatment with follicle-stimulating hormone for assisted reproduction
- •No HIV-positive patients on concurrent combination antiretroviral therapy
排除标准
- 未提供
研究组 & 干预措施
Recombinant human chorionic gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Recombinant human chorionic gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
干预措施: needle biopsy (Procedure)
Recombinant human chorionic gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
干预措施: microarray analysis (Genetic)
Recombinant human chorionic gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
干预措施: immunohistochemistry staining method (Other)
Recombinant human chorionic gonadotropin
Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
干预措施: recombinant human chorionic gonadotropin (Biological)
结局指标
主要结局
Measurement of Gene Expression in Breast Epithelial Cells Obtained for Asymptomatic High Breast Cancer Risk Nulliparous Premenopausal Women at Baseline, After Treatment With r-hCG at 90 Days, and at 270 Days From Baseline
时间窗: 90 days and 270 days from baseline
次要结局
未报告次要终点