A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
- 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
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
- Arm II: Patients receive oral placebo once daily for 1 year in the absence of
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Percentage change of the BMD parameters from baseline BMD values
Paul E. Goss, MD, PhD
Massachusetts General Hospital
United States: Federal Government
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|