An Exploratory Study to Identify Potential Surrogate Endpoint Biomarkers That Are Modulated by Tamoxifen vs. Placebo in Women With an Increased Risk for Breast Cancer
- Compare molecular markers of proliferation and apoptosis in breast epithelial tissue of
women at increased risk for breast cancer treated with tamoxifen vs placebo.
- Compare the modulation of markers of genomic instability in breast epithelial tissue of
patients treated with these drugs.
- Compare serum levels of IGF-1, IGF-2, and IGFBP-3 of these patients at baseline and
after treatment with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to estimated 5-year breast cancer risk (1.67-5% vs ≥ 5%), presence
of atypical ductal hyperplasia (yes vs no), and menopausal status (premenopausal vs
postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen once daily.
- Arm I: Patients receive oral placebo once daily. Treatment in both arms continues for 3
months in the absence of invasive breast cancer or unacceptable toxicity.
Patients undergo core needle biopsy and fine needle aspiration biopsy at baseline and then
at the completion of study treatment (for premenopausal patients); exactly 84 days after the
first biopsy (for postmenopausal patients); or on the first or second day of the menstrual
cycle on or after 84 days (during the third menstrual cycle) after the first dose of study
medication (for patients with irregular menses).
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 130 patients (65 per arm) will be accrued for this study
within 30 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Plasma levels of hormones and binding proteins as measured by ELISA, IHC, and TUNEL at baseline and 3 months
David M. Euhus, MD
Simmons Cancer Center
United States: Federal Government
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|