Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00077025

Run by

AstraZeneca

People needed

174

Starts

2004-01-01

Expected to finish

2013-05-01

Last updated by the study team

2014-07-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 Township, 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 and San Felix, Venezuela

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.