Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
NCT ID: NCT00077025
Last Updated: 2014-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
174 participants
INTERVENTIONAL
2004-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anastrozole-placebo
Anastrozole (ZD1033, Arimidex)-Placebo
Anastrozole
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
Anastrozole-ZD1839
Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)
Gefitinib
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
Interventions
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Gefitinib
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
Anastrozole
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Iressa Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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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
Research Site
San Cristóbal, , Venezuela
Research Site
Valencia, , Venezuela
Countries
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Related Links
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Other Identifiers
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1839US/0713
Identifier Type: -
Identifier Source: org_study_id
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