Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

NCT00285857 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB-13732BRSNSTU001095505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

duct cytology

Outcome Measures

Primary Outcomes (1)

• Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day

  Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day. Cytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows: 06-10 Non-proliferative breast disease (NPBD) 11-14 Proliferative breast disease without atypia (PBD-A) 15-18 Proliferative breast disease with atypia (PBD+A) 19-24 Carcinoma in situ and invasive cancer (CIS/IC) If no cells could be obtained after multiple RPFNA attempts, the classification was acellular. Change from NPBD to PBD-A was considered Unfavorable. Change from NPBD to Acellular was considered Equivocal. Change from PBD-A to NPBD was considered Favorable.

  6 months

Secondary Outcomes (3)

• Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day

  6 months

• Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day

  6 months

• Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day

  6 months

Study Arms (1)

Lovastatin 80 mg/day

EXPERIMENTAL

Lovastatin 80 mg/day as 40 mg orally twice daily, for 6 months.

Drug: Lovastatin

Interventions

Lovastatin DRUG

Lovastatin 80 mg/day as 40 mg orally twice daily. Lovastatin is approved by FDA as a cholesterol-lowering agent.

Also known as: Mevacor, Advicor (as a combination with niacin), Altocor, Altoprev, Statosan (Atos Pharma)

Lovastatin 80 mg/day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 myopathy or myositis, including symptoms of generalized muscle aches or weakness, muscle tenderness, or elevation in creatine phosphokinase.
• Lactating (breastfeeding)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Cancer Center

Stanford, California, 94305, United States

Location

Related Publications (1)

• Vinayak S, Schwartz EJ, Jensen K, Lipson J, Alli E, McPherson L, Fernandez AM, Sharma VB, Staton A, Mills MA, Schackmann EA, Telli ML, Kardashian A, Ford JM, Kurian AW. A clinical trial of lovastatin for modification of biomarkers associated with breast cancer risk. Breast Cancer Res Treat. 2013 Nov;142(2):389-98. doi: 10.1007/s10549-013-2739-z. Epub 2013 Oct 29.

  PMID: 24166281 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lovastatin; lovastatin-niacin combination; Niacin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: James M. Ford
• Organization: Stanford University

jmf@stanford.edu

(650) 498-6689

Study Officials

• James Ford, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: November 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)