Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density|
- Percentage change of the BMD parameters from baseline BMD values [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values [ Time Frame: 7 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2000|
|Study Completion Date:||February 2009|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: Letrozole||
2.5 mg PO daily for 1 year
|Placebo Comparator: Placebo||
2.5 mg PO daily for one 1 year
- 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.
- 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.
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115-6084|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Hamilton Osteoporosis Diagnostic Services|
|Hamilton, Ontario, Canada, L8N 1Y2|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|St. Catharines General Hospital at Niagara Health System|
|St. Catharines, Ontario, Canada, L2R 5K3|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Hotel Dieu de Montreal|
|Montreal, Quebec, Canada, H2W 1T8|
|Study Chair:||Paul E. Goss, MD, PhD||Massachusetts General Hospital|