Phase II Clinical Trial of N-(4-hydroxyphenyl) Retinamide (4-HPR) and Tamoxifen in Breast Neoplasia, Administration During the Period Between the Diagnostic Core Biopsy and Definitive Surgery
OBJECTIVES: I. Determine the feasibility of identifying surrogate endpoint biomarkers in
women with breast ductal carcinoma in situ and associated neoplastic and preneoplastic
lesions. II. Determine whether treatment with fenretinide and tamoxifen administered daily
will cause significant modulation of proposed surrogate endpoint biomarkers in this patient
population.
OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according
to histological diagnosis (hyperplasia vs carcinoma). All patients undergo a core biopsy and
fine needle aspiration of the index lesion and are then assigned randomly to a treatment
arm. Arm I receives tamoxifen and fenretinide daily. Arm II receives a placebo daily. Both
arms continue for 14-28 days, until definitive surgery or a second biopsy is performed.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study, 50 patients per
arm.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer
28 days
No
Sonja E. Singletary, MD
Study Chair
M.D. Anderson Cancer Center
United States: Institutional Review Board
ID94-029
NCT00003099
May 1996
January 2003
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |