NCT00049062

Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: * 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 regimen. * 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 regimen. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior objective response to endocrine therapy (yes vs no). 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 study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	anastrozole
DRUG	gefitinib

Timeline

• Start date: 2002-09-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-02-21

Locations

1 site across 1 country: United States