Official Title: “Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer”

This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Gefitinib
• Drug: Anastrozole

Primary Measures

• Time to progression

Secondary Measures

• Objective response rate
• Overall clinical benefit rate
• Overall survival
• Safety
• Pharmacokinetic variables
• Exploratory outcome variables
• Biomarker variables

Inclusion Criteria:

• Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer.
• Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial.
• A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required.

Exclusion Criteria:

• Patients cannot be on hormone replacement therapy while on study.
• Prior chemotherapy received for metastatic disease is not allowed.
• Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed.
• Patients who have evidence of an active interstitial lung disease are not eligible.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Iressa Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00077025

Study ID Number: 1839US/0713

ClinicalTrials.gov Identifier: NCT00077025

Health Authority: United States: Food and Drug Administration