Trial Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 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...
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”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: January 2013
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 Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Iressa Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00077025
