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 has been completed.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00077025

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Gefitinib Drug: Anastrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole ZD1839 Progesterone

U.S. FDA Resources

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to progression

Secondary Outcome Measures:

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

Estimated Enrollment:	174
Study Start Date:	August 2003
Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077025

Show 38 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Iressa Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839US/0713
Study First Received:	February 9, 2004
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00077025
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

metastatic breast cancer

Study placed in the following topic categories:

Anastrozole
Progesterone
Skin Diseases

Breast Neoplasms
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Protein Kinase Inhibitors

Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Progestins
Therapeutic Uses
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009