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	Treatment or Intervention	Phase
Breast Cancer	Drug: Gefitinib  Drug: Anastrozole	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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.

AstraZeneca Information Center (8am-7pm EST)      800-236-9933 

Alaska
      Research Site, Anchorage,  Alaska,  United States; No longer recruiting
California
      Research Site, La Jolla,  California,  United States; Recruiting
      Research Site, Walnut Creek,  California,  United States; Recruiting
      Research Site, La Verne,  California,  United States; Recruiting
      Research Site, Santa Barbara,  California,  United States; Recruiting
Florida
      Research Site, Orlando,  Florida,  United States; Recruiting
Georgia
      Research Site, Albany,  Georgia,  United States; Recruiting
Louisiana
      Research Site, Lafayette,  Louisiana,  United States; Recruiting
Maryland
      Research Site, Rockville,  Maryland,  United States; Recruiting
Massachusetts
      Research Site, Pittsfield,  Massachusetts,  United States; Recruiting
Missouri
      Research Site, Columbia,  Missouri,  United States; Recruiting
Nebraska
      Research Site, Omaha,  Nebraska,  United States; Recruiting
Nevada
      Research Site, Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Research Site, Voorhees,  New Jersey,  United States; Recruiting
New Mexico
      Research Site, Albuquerque,  New Mexico,  United States; Recruiting
New York
      Research Site, Great Neck,  New York,  United States; Recruiting
Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting
Pennsylvania
      Research Site, Allentown,  Pennsylvania,  United States; No longer recruiting
South Carolina
      Research Site, Greenville,  South Carolina,  United States; Recruiting
South Dakota
      Research Site, Sioux Falls,  South Dakota,  United States; Recruiting
Texas
      Research Site, San Antonio,  Texas,  United States; Recruiting
      Research Site, Temple,  Texas,  United States; Recruiting
      Research Site, Houston,  Texas,  United States; Recruiting
      Research Site, Dallas,  Texas,  United States; Recruiting

Study ID Numbers:  ZD1839US/0713
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  February 9, 2004
ClinicalTrials.gov Identifier:  NCT00077025
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08