Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
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.
Biological: recombinant human chorionic gonadotropin
Genetic: microarray analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: needle biopsy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk|
- 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 [ Time Frame: 90 days and 270 days from baseline ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Biological: recombinant human chorionic gonadotropin Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: needle biopsy|
- 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.
- 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.
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67 immunohistochemical staining for cell proliferation, cDNA microarray for gene expression, and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700778
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Universitaetsklinik fuer Frauenheilkunde|
|Vienna, Austria, A-1090|
|Principal Investigator:||Jose Russo, MD, FCAP||Fox Chase Cancer Center|