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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Principal Investigator

Iressa Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

1839US/0713

NCT ID:

NCT00077025

Start Date:

January 2004

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • metastatic breast cancer
  • Breast Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteAberdeen, South Dakota  
Research SiteAbilene, Texas