Clinical Trial: Chemoprevention Therapy Plus Surgery in Treating Patients With Breast Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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 patients with breast cancer.

Condition Treatment or Intervention Phase
stage I breast cancer
ductal breast carcinoma
invasive ductal breast carcinoma
prevention of breast cancer
stage II breast cancer
 Drug: fenretinide
 Drug: tamoxifen
Phase II

MedlinePlus related topics:  Breast Cancer;   Cancer;   Cancer Alternative Therapy
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Phase II Study of Fenretinide and Tamoxifen Prior to Definitive Surgery for Breast Neoplasia

Further Study Details: 

Study start: May 1996

OBJECTIVES: I. Determine the feasibility of identifying surrogate endpoint biomarkers in 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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

Location Information


Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Sonja Eva Singletary,  Study Chair,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065829; MDA-ID-94029; NCI-P97-0113
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003099
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005