A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy
- Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective
response (partial or complete) or stable disease at 6 months, in post-menopausal women
with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
- Determine the progression-free and overall survival of patients treated with this
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate molecular markers with clinical benefit in patients treated with this
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to prior objective response to endocrine therapy (yes vs
Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral
anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this
Masking: Open Label, Primary Purpose: Treatment
Eric K. Rowinsky, MD
Cancer Therapy and Research Center, Texas
United States: Food and Drug Administration
|Cancer Therapy and Research Center||San Antonio, Texas 78229|