Ignite Creation Date:
2024-05-05 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00700778
Status:
TERMINATED
Last Update Posted:
2021-01-25
First Post:
2008-06-18
Brief Title:
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit volunteers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06827 | OTHER | None | None |
| R21CA124522 | NIH | Fox Chase Cancer Center | httpsreporternihgovquickSearchR21CA124522 |