A Phase II, Randomized, Double-Masked, Multicenter Study of Two Dose Levels of ERA-923 for the Treatment of Metastatic Breast Cancer in Postmenopausal Women Who Have Failed Tamoxifen Therapy
OBJECTIVES: I. Compare the efficacy of 2 dose levels of ERA-923 in postmenopausal patients
with metastatic breast cancer refractory to tamoxifen. II. Determine the safety and plasma
levels of this drug in these patients. III. Determine the impact on quality of life of these
patients by this drug.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to
one of two treatment arms receiving different doses of ERA-923. Patients receive oral
ERA-923 daily for 48 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline; at weeks 4, 8, 16, 24, 32, 40, and 48; and then at
4 weeks after last dose. Patients are followed at 4 weeks and then every 3 months
thereafter.
PROJECTED ACCRUAL: At total of 36-100 patients (18-50 per arm) will be accrued for this
study within 1 year.
Interventional
Primary Purpose: Treatment
Susan Minton, DO
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
CDR0000068242
NCT00006369
June 2000
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |