A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
- 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
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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Carol J. Fabian, MD
University of Kansas
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Loyola University Medical Center||Maywood, Illinois 60153|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Comprehensive Cancer Centers of the Desert||Palm Springs, California 92262|
|U.S. Oncology Research Inc.||Houston, Texas 77060|