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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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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

Inclusion 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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Fenretinide + Tamoxifen effectiveness given before surgery in treating breast cancer

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Sonja E. Singletary, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 1996

Completion Date:

January 2003

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Tamoxifen
  • Fenretinide
  • Chemoprevention Therapy
  • N-(4-hydroxyphenyl) Retinamide
  • 4-HPR
  • Breast Neoplasia
  • Diagnostic Core Biopsy
  • Surgery
  • Breast Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009