Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-26 @ 3:05 PM
Study NCT ID:
NCT00285857
Status:
TERMINATED
Last Update Posted:
2017-03-09
First Post:
2006-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Lovastatin for Modification of Abnormal Breast Duct Cytology and Risk-Associated Biomarkers in Women at High Inherited Risk of Breast Cancer
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk.
Detailed Description:
The study evaluates if a 6-month course of oral lovastatin at 80 mg/day (as 40 mg twice-a-day) would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk. Breast duct cytology was assessed as hyperplasia or hyperplasia with atypia, as measured by random periareolar fine needle aspiration (rpFNA), of breast duct cells.
A stratified analysis of this objective will be performed according to BRCA mutation status (absence or presence of an inherited deleterious BRCA1 or BRCA2 mutation).
Additional objectives of the study are to:
* Assess change in mammographic density, which is known to associate with breast cancer risk, before and after treatment with lovastatin
* Asess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.
* Assess change in other breast cancer risk-associated biomarkers in rpFNA specimens, including:
* Ki-67 (a marker of cell proliferation)
* Estrogen receptor (ER)
* Progesterone receptor (PR)
* HER/2-neu over-expression
* Susceptibility to DNA damage
A stratified analysis of this objective will be performed according to BRCA mutation status (absence or presence of an inherited deleterious BRCA1 or BRCA2 mutation).
Additional objectives of the study are to:
* Assess change in mammographic density, which is known to associate with breast cancer risk, before and after treatment with lovastatin
* Asess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.
* Assess change in other breast cancer risk-associated biomarkers in rpFNA specimens, including:
* Ki-67 (a marker of cell proliferation)
* Estrogen receptor (ER)
* Progesterone receptor (PR)
* HER/2-neu over-expression
* Susceptibility to DNA damage
Study Oversight
Has Oversight DMC:
True
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?: