Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00285857

Run by

Stanford University

People needed

30

Starts

2005-11-01

Expected to finish

2010-12-01

Last updated by the study team

2017-03-09

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Increased inherited risk of breast cancer, as defined by:
• Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation
• Family history conveying at least a 2-fold increase in breast cancer risk
• ECOG performance status 0
• Normal organ and marrow function, including complete blood count and comprehensive metabolic panel within normal institutional limits
• Subject agreement to limit alcoholic beverage consumption to three alcoholic drinks per week.

You may not qualify if…

• Prior history of invasive breast cancer less than 2 years previously (EXCEPTION: stage III or lower breast cancer > 2 years ago)
• Current or history of other cancers (EXCEPTION: non-melanoma skin cancer, or stage III or cancer without evidence of recurrence for 5 years
• Initial mammogram, breast MRI, or clinical breast examination prompts recommendation for biopsy by study investigators.
• Evidence of malignant cytology on initial rpFNA.
• Use of other investigational agents.
• Use of tamoxifen or selective estrogen response modifiers (SERMS), including raloxifene, within the last 2 years.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
• Currently receiving lovastatin and cyclosporine, gemfibrozil, erythromycin, fibrates or niacin, (unless discontinued for study participation)
• No evidence of active liver disease, nor elevation of serum transaminases (prior history of liver disease, if not currently active, is not an exclusion)
• No evidence of myopathy or myositis, including symptoms of generalized muscle aches or weakness, muscle tenderness, or elevation in creatine phosphokinase.
• Lactating (breastfeeding)

Where it is running

• Stanford University Cancer Center — Stanford, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.