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...
Date First Received: February 9, 2004
Last Updated: April 22, 2009
Verified by: AstraZeneca, April 2009
Clinical Trial Phase: Phase 2 | Start Date: August 2003
Overall Status: Active, not recruiting
Estimated Enrollment: 174
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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
Study Primary Completion Date: January 2007
Intervention(s) in this Clinical Trial
- Drug: Gefitinib
- Drug: Anastrozole
Outcome Measures for this Clinical Trial
Primary Measures
- Time to progression
Secondary Measures
- Objective response rate
- Overall clinical benefit rate
- Overall survival
- Safety
- Pharmacokinetic variables
- Exploratory outcome variables
- Biomarker variables
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Iressa Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
