Know Cancer

or
forgot password

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


Phase 2
18 Years
65 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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


Inclusion Criteria:



- Women with an increased inherited risk of breast cancer, but no current breast
cancer. Defined by either:

- Known deleterious mutation in BRCA1, BRCA2, or other high-risk mutation

- 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.

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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

James Ford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

BRSNSTU0010

NCT ID:

NCT00285857

Start Date:

November 2005

Completion Date:

November 2016

Related Keywords:

  • Breast Cancer
  • breast cancer
  • lovastatin
  • duct cytology
  • Breast Neoplasms

Name

Location

Stanford University Cancer CenterStanford, California  94305