Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005886|
Recruitment Status : Completed
First Posted : August 29, 2003
Last Update Posted : January 13, 2017
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: arzoxifene hydrochloride Drug: tamoxifen citrate||Phase 1|
- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily.
Upon completion of phase I, all treatment centers begin phase II of the study.
- Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo daily.
Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy) in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 and 2 weeks after surgery.
PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||August 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005886
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Comprehensive Cancer Centers of the Desert|
|Palm Springs, California, United States, 92262|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7357|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|United States, Texas|
|U.S. Oncology Research Inc.|
|Dallas, Texas, United States, 75246|
|Study Chair:||Carol J. Fabian, MD||University of Kansas|