Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
- Registration Number
- NCT00238316
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high breast density.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.
- Detailed Description
OBJECTIVES:
Primary
* Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole for 1 year.
Secondary
* Determine whether a decrease in breast density grade is sustained at 1 year in patients treated with this drug.
* Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline in these patients.
* Determine the percentage of patients with breast tissue hyperplasia and atypical hyperplasia, as assessed by histopathological examination of breast tissue biopsies, before and after treatment with this drug.
* Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after cessation of this drug in these patients.
* Compare changes in predetermined specific parameters of safety at the end of 1 year of treatment with this drug with baseline evaluations of these patients.
* Determine whether modifications of these predetermined specific parameters of safety are sustained 1 year after cessation of treatment with this drug in these patients.
* Determine the general safety of 1 year of treatment with this drug in these patients.
* Compare the effects of this drug on menopause-specific quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to breast density grade (4/6 vs 5/6 vs 6/6). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral letrozole once daily for 1 year in the absence of unacceptable toxicity.
* Arm II: Patients receive oral placebo once daily for 1 year in the absence of unacceptable toxicity.
Menopause-specific quality of life is assessed at baseline and then at 12 and 24 months.
After completion of study treatment, patients are followed at 6 months and 1 year.
PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole letrozole - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage change of the BMD parameters from baseline BMD values 7 years Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values 7 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Hamilton Osteoporosis Diagnostic Services
🇨🇦Hamilton, Ontario, Canada
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Hotel Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Ottawa Hospital Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
St. Catharines General Hospital at Niagara Health System
🇨🇦St. Catharines, Ontario, Canada