A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels
- Compare the safety, acceptability, and adherence to letrozole vs placebo in
postmenopausal women at increased risk for the development or recurrence of breast
cancer based on elevated plasma estradiol levels.
- Compare the effects of these regimens on menopausal symptoms (including hot flushes,
weight changes, sexual functioning, and genitourinary effects), blood lipid levels,
markers of bone turnover, and multidimensional quality of life in patients treated with
- Determine the effect of letrozole-induced reduction of plasma estradiol levels on
mammographic percent breast density in these patients.
OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study.
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for 1 year. Patients may then receive
additional oral letrozole once daily for up to 4 years.
- Arm II: Patients receive oral placebo once daily for 1 year. Patients may then receive
oral letrozole once daily for up to 5 years.
In both arms, treatment continues in the absence of unacceptable toxicity or diagnosis of
invasive breast cancer, ductal carcinoma in situ, or any non-breast primary cancer.
Quality of life is assessed at baseline and then at 3, 6, and 12 months.
PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued
for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Safety, acceptability, and adherence
Judy Garber, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dan L. Duncan Cancer Center at Baylor College of Medicine||Houston, Texas 77030|