Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Other: Placebo; Drug: Fenretinide; Drug: Tamoxifen Citrate

• Registration Number: NCT00003099
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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 Timeline

• Study Start: 1996-05
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-06
• Study Completion: 2003-01
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1 Tamoxifen + Fenretinide	Tamoxifen Citrate	Tamoxifen + Fenretinide daily for 14-28 days
Arm 2 Placebo	Placebo	Placebo daily for 14-28 days
Arm 1 Tamoxifen + Fenretinide	Fenretinide	Tamoxifen + Fenretinide daily for 14-28 days

Primary Outcome Measures

Name	Time	Method
Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer	28 days

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States