Hormone Therapy in Treating Postmenopausal Women With Receptor-Positive Breast Cancer
|ClinicalTrials.gov Identifier: NCT00002646|
Recruitment Status : Completed
First Posted : June 10, 2004
Last Update Posted : January 5, 2012
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining chemotherapy with hormone therapy may kill more tumor cells. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the recurrence of breast cancer. It is not yet known whether tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen plus fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage III breast cancer that is estrogen receptor positive and/or progesterone receptor positive.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: fenretinide Drug: tamoxifen citrate||Phase 3|
OBJECTIVES: I. Compare disease free survival and overall survival of postmenopausal women with stage II or IIIA breast cancer treated with tamoxifen (TMX) and fenretinide (HPR) vs TMX and placebo. II. Gain wider experience in the use and toxicity of combined TMX/HPR in these patients. III. Obtain tumor tissue samples, as feasible, from these patients for future biologic studies.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified by participating institution, age (under 70 vs 70 and over), node dissection (yes vs no), number of involved nodes (0 vs 1-3 vs 4 or more), and number of removed nodes (1-5 vs 6 or more). All patients receive oral tamoxifen daily for at least 5 years, beginning immediately after randomization. Patients also receive either oral fenretinide or oral placebo daily for 5 years, beginning within 2 weeks after completion of any radiotherapy, or within 2 weeks of randomization, if no radiation. Patients are followed during and after treatment every 4 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study over approximately 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Official Title:||PHASE III DOUBLE-BLIND, PLACEBO-CONTROLLED, PROSPECTIVE RANDOMIZED COMPARISON OF ADJUVANT THERAPY WITH TAMOXIFEN VS. TAMOXIFEN AND FENRETINIDE IN POSTMENOPAUSAL WOMEN WITH INVOLVED AXILLARY LYMPH NODES AND POSITIVE RECEPTORS|
|Study Start Date :||October 1995|
|Actual Primary Completion Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002646
Show 85 Study Locations
|Study Chair:||Melody A. Cobleigh, MD||Rush University Medical Center|
|Study Chair:||George Thomas Budd, MD||The Cleveland Clinic|
|Study Chair:||Mark L. Graham, MD||UNC Lineberger Comprehensive Cancer Center|
|Study Chair:||James N. Ingle, MD||Mayo Clinic|