Status:
COMPLETED
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 breas...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00077025
Start Date
January 1 2004
End Date
May 1 2013
Last Update
July 16 2014
Active Locations (27)
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1
Research Site
La Jolla, California, United States
2
Research Site
San Diego, California, United States
3
Research Site
Orlando, Florida, United States
4
Research Site
Lafayette, Louisiana, United States