Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00003099
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: May 1996
• Completion date: January 2003