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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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00077025
First received: February 9, 2004
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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: January 2004
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00077025     History of Changes
Other Study ID Numbers: 1839US/0713
Study First Received: February 9, 2004
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Progesterone
Anastrozole
Gefitinib
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Progestins
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013