Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide and tamoxifen before surgery may be an effective way to prevent the recurrence of or further development of breast cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide and tamoxifen given before surgery in treating women with breast cancer.
Drug: Tamoxifen Citrate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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|
- Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 1996|
|Study Completion Date:||January 2003|
|Primary Completion Date:||June 2000 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1 Tamoxifen + Fenretinide
Tamoxifen + Fenretinide daily for 14-28 days
Daily for 14-28 days.
Other Names:Drug: Tamoxifen Citrate
Daily for 14-28 days.
Other Name: Nolvadex
Placebo Comparator: Arm 2 Placebo
Placebo daily for 14-28 days
Daily for 14-28 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003099
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Sonja E. Singletary, MD||M.D. Anderson Cancer Center|