Spots Global Cancer Trial Database for Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
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Trial Identification
Brief Title: Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
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
Study ID: NCT00077025
Conditions
Study Description
Brief Summary: 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.
Detailed Description: This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, La Jolla, California, United States
Research Site, San Diego, California, United States
Research Site, Orlando, Florida, United States
Research Site, Lafayette, Louisiana, United States
Research Site, Rockville, Maryland, United States
Research Site, Columbia, Missouri, United States
Research Site, Omaha, Nebraska, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Voorhees, New Jersey, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Lake Success, New York, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Allentown, Pennsylvania, United States
Research Site, Sioux Falls, South Dakota, United States
Research Site, Houston, Texas, United States
Research Site, Temple, Texas, United States
Research Site, Cali, , Colombia
Research Site, Aguascalientes, , Mexico
Research Site, Guadalajara, , Mexico
Research Site, Morelia, , Mexico
Research Site, Barcelona, , Venezuela
Research Site, Barquisimeto, , Venezuela
Research Site, Caracas, , Venezuela
Research Site, Maracaibo, , Venezuela
Research Site, Puerto Ordaz, , Venezuela
Research Site, San Cristobal, , Venezuela
Research Site, Valencia, , Venezuela
Contact Details
Name: Iressa Medical Science Director, MD
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
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