James Ford
Phase II Trial - Breast Cancer Chemoprevention by Lovastatin
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Lovastatin
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Women with an increased inherited risk of breast cancer, but no current breast cancer. Defined by either:
o Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation
o Family history conveying at least a 2-fold increase in breast cancer risk
- Only those patients without evidence of abnormality requiring biopsy on mammography, breast MRI, or clinical breast examination will be eligible for inclusion.
- Patients must have ECOG performance status 0.
- Patients must have normal organ and marrow function, including complete blood count and comprehensive metabolic panel within normal institutional limits.
- Patients must have no evidence of active liver disease, or elevation of serum transaminases. Prior history of liver disease, if not currently active, will not exclude patients from participation. Patients must have no evidence of myopathy or myositis, including symptoms of generalized muscle aches or weakness, muscle tenderness, or elevation in creatine phosphokinase. In order to be eligible for participation, patients will be asked to limit alcoholic beverage consumption to three alcoholic drinks per week. This is specified because of recommendations for caution with use of lovastatin in patients with heavy alcohol use.
- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Only women who are not currently breastfeeding will be eligible to participate.
Key Exclusion Criteria:
- Patients with prior history of invasive breast cancer less than 2 years previously unless they had stage III or lower breast cancer more than 2 years ago.
- Patients with history of other cancer, excluding non-melanoma skin cancer, unless the cancer was stage III or lower, and they have been without evidence of recurrence for 5 years.
- Patients who show evidence of malignant cytology on initial rpFNA.
- Patients whose initial mammogram, breast MRI, or clinical breast exam prompts recommendation for biopsy by study investigators.
- Patients using other investigational agents.
- Use of tamoxifen or selective estrogen response modifiers (SERMS), including raloxifene; patients who have taken these agents within the last 2 years.
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin.
- Patients with 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.
- Patients on concurrent lovastatin and cyclosporine, gemfibrozil, erythromycin, fibrates or niacin, unless they discontinue them.
Additional Study Details
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 CancerAnticipated start date:
11/1/2005Lead Sponsor:
Breast Cancer Research FoundationCollaborator(s):
- ASCO
- Vadasz Family Foundation
Investigator(s):
- Allison Walsh Kurian
- Ava Kwong
- James M Ford
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- 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.
Secondary Outcomes:
- 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.
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
60More Information
Secondary ID(s):
- 95505
- BRSNSTU0010
- NCT00285857
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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