Phase II Trial - Breast Cancer Chemoprevention by Lovastatin

Breast Cancer Clinical Trial

Official title: A Phase II 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

Clinical Trial Summary

The purpose of the study is to determine whether oral lovastatin, used for 6 months, results in a decrease of abnormal breast duct cytology in women at high inherited breast cancer risk.

Clinical Trial Description

The purpose of the study is to determine whether oral lovastatin, given daily at a dose of 80 mg for six months, results in a decrease in the rate of abnormal breast duct cytology (either hyperplasia or hyperplasia with atypia as measured by random periareolar fine needle aspiration (rpFNA) of breast duct cells) in women at high inherited breast cancer risk. 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

• To assess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.

• To 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00285857
• Study type: Interventional
• Source: Stanford University
• Status: Terminated
• Phase: Phase 2
• Start date: November 2005
• Completion date: December 2010