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

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00049062
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2002-11-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States