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.

First Received: February 9, 2004 Last Updated: April 22, 2009 History of Changes

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: Progesterone Anastrozole ZD1839

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
Estimated Study Completion Date:	February 2010
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	1839US/0713
Study First Received:	February 9, 2004
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00077025 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

metastatic breast cancer

Study placed in the following topic categories:

Anastrozole
Estrogens
Skin Diseases
Progesterone
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Breast Neoplasms
Protein Kinase Inhibitors
Hormones
Progestins
Aromatase Inhibitors
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Skin Diseases
Progesterone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Enzyme Inhibitors

Protein Kinase Inhibitors
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Progestins
Aromatase Inhibitors
Gefitinib
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009