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
317 participants
INTERVENTIONAL
2003-10-31
2015-06-30
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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1
ZD1839 + Nolvadex
Gefitinib
Tamoxifen
2
Nolvadex + placebo
Tamoxifen
Interventions
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Gefitinib
Tamoxifen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A tissue block from either the metastatic or primary tumor site is required.
* WHO performance status (PS) 0-2
* Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as:
* natural menopause with last menses \> 1 year ago,
* radiation induced oophorectomy with last menses \> 1 year ago,
* chemotherapy induced menopause with 1 year interval since last menses, or
* serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution.
* bilateral oophorectomy
Exclusion Criteria
* Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
* Treatment with LH-RH analog.
* Laboratory values as follow Bilirubin \>1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) \>2.5 times the ULN if no demonstrable liver metastases, or \>5 times the ULN in the presence of liver metastases
* Bone marrow function: WBC \<1500 mm3
18 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Iressa Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Berkeley, California, United States
Research Site
Palm Springs, California, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Bahía Blanca, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Córdoba, , Argentina
Research Site
El Palomar, , Argentina
Research Site
Resistencia, , Argentina
Research Site
Rosario, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Santa Fe, , Argentina
Research Site
Vicente López, , Argentina
Research Site
Bentleigh East, , Australia
Research Site
Newcastle, , Australia
Research Site
Randwick, , Australia
Research Site
Westmead, , Australia
Research Site
Wodonga, , Australia
Research Site
Brussels, , Belgium
Research Site
Leuven, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Belo Horizonte, , Brazil
Research Site
Curitiba, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Saint John, New Brunswick, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Herlev, , Denmark
Research Site
Lyon, , France
Research Site
Mougins, , France
Research Site
Poitiers, , France
Research Site
Rouen, , France
Research Site
Frankfurt, , Germany
Research Site
Jena, , Germany
Research Site
Kiel, , Germany
Research Site
München, , Germany
Research Site
Trier, , Germany
Research Site
Durban, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Klerksdorp, , South Africa
Research Site
Observatory, , South Africa
Research Site
Barcelona, , Spain
Research Site
Córdoba, , Spain
Research Site
Madrid, , Spain
Research Site
Majadahonda, , Spain
Research Site
Zaragoza, , Spain
Research Site
Colchester, , United Kingdom
Research Site
Dundee, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Nottingham, , United Kingdom
Countries
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Related Links
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Other Identifiers
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D7917C00225
Identifier Type: -
Identifier Source: secondary_id
1839IL/0225
Identifier Type: -
Identifier Source: org_study_id
NCT00069290
Identifier Type: -
Identifier Source: nct_alias
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