Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
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|ClinicalTrials.gov Identifier: NCT00700778|
Recruitment Status : Terminated (Unable to recruit volunteers)
First Posted : June 19, 2008
Last Update Posted : December 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|BRCA1 Mutation Breast Cancer||Biological: recombinant human chorionic gonadotropin Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: needle biopsy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|