NCT00700778

Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations

Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. 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.

Conditions

• BRCA1 Mutation
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	recombinant human chorionic gonadotropin
GENETIC	microarray analysis
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis
PROCEDURE	needle biopsy

Timeline

• Start date: 2008-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2008-06-19
• Last updated: 2021-01-25
• Results posted: 2021-01-25

Locations

3 sites across 2 countries: United States, Austria