Viewing Study NCT00049062



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Study NCT ID: NCT00049062
Status: COMPLETED
Last Update Posted: 2013-02-21
First Post: 2002-11-12

Brief Title: Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: 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
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CTRC-IDD-0228 None None None
CTRC-IDD-0219 None None None
CTRC-IDD-1839US None None None