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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: February 9, 2004
Last updated: January 30, 2013
Last verified: January 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- Objective response rate
- Overall clinical benefit rate
- Overall survival
- Pharmacokinetic variables
- Exploratory outcome variables
- Biomarker variables
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077025
||Iressa Medical Science Director, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 9, 2004
||January 30, 2013
||United States: Food and Drug Administration
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors