A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A PreSurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue and Normal Skin After Short Term Exposure to ZD1839 (IRESSA) and to Correlate These Alterations With Pharmacokinetic Parameters.
Inclusion Criteria:
- Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial
diagnosis
Exclusion Criteria:
- Pregnant or lactating patients, Prior or current radiotherapy for breast cancer,
Known allergy reaction to Iressa
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Molecular alterations occuring in breast cancer tissue following Iressa treatment
Outcome Time Frame:
At time of diagnosis and time of patient surgery
Authority:
United States: Food and Drug Administration
Study ID:
1839IL/0219
NCT ID:
NCT00637026
Start Date:
July 2003
Completion Date:
February 2005
Related Keywords:
- Breast Cancer
- Iressa, Gefitinib, Breast Cancer, Surgery
- Breast Neoplasms
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