Letrozole in Preventing Breast Cancer in Postmenopausal Women
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels|
- Safety, acceptability, and adherence
- Effects on menopausal symptoms
- Effects on mammographic percent breast density
|Study Start Date:||September 2000|
- 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 these regimens.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090857
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|Dan L. Duncan Cancer Center at Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Judy Garber, MD||Dana-Farber Cancer Institute|
|Principal Investigator:||Patricia A. Ganz, MD||Jonsson Comprehensive Cancer Center|