Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemoprevention Therapy Plus Surgery in Treating Women With Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Closed Over 18 NCI MDA-ID-94029 NCI-P97-0113, NCT00003099

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.

Entry Criteria

Disease Characteristics:

Mammogram highly suspicious for ductal carcinoma in situ or early invasive
carcinoma
 Branching or linear microcalcifications clustered or distributed segmentally
  in the breast without an associated palpable or mammographic mass
 Palpable thickening or nipple discharge allowed
 At least 5 mm area of calcification or contain enough calcium for core
  biopsies

Small palpable carcinoma (T1 or T2) with no palpable axillary lymph nodes (N0)

No definitive local therapy

Atypical hyperplasia (ductal or lobular) and/or carcinoma on initial
diagnostic biopsy

Hormone receptor status:
 Not specified

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified   

Chemotherapy:
 At least 5 years since prior chemotherapy

Endocrine therapy:
 At least 12 months since prior tamoxifen therapy
 No concurrent estrogen therapy
 At least 3 months since prior anabolic steroids

Radiotherapy:
 No prior radiotherapy to the chest or breast

Surgery:
 See Disease Characteristics

Other:
 No vitamin A supplementation greater than 25,000 IU
 At least 12 months since prior retinoid therapy

Patient Characteristics:

Age:
 Over 18

Sex:
 Female

Menopausal status:
 Not specified

Performance status:
 Zubrod 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Absolute granulocyte count greater than 1500/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 mg/dL

Renal:
 Creatinine no greater than 1.5 mg/dL

Cardiovascular:
 No uncontrolled congestive heart failure

Other:
 Fasting serum triglycerides less than 400 mg/dL
 Fertile patients must use effective contraception during and for one year
  after completing fenretinide therapy
 No concurrent serious illness or infection, e.g., septicemia
 No prior thromboembolic disease
 No prior degenerative retinal disease

Expected Enrollment

 A total of 100 patients will be accrued for this study, 50 patients per arm.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Sonja Singletary, MD, Protocol chair		Ph: 713-792-6937; 800-392-1611

Registry Information
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
Trial Start Date		1996-05-03
Registered in ClinicalTrials.gov		NCT00003099
Date Submitted to PDQ		1997-10-06
Information Last Verified		2006-12-28
NCI Grant/Contract Number		P30-CA16672

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