A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
OBJECTIVES:
- 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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Carol J. Fabian, MD
Study Chair
University of Kansas
United States: Federal Government
CDR0000067956
NCT00005886
July 2000
Name | Location |
---|---|
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 |