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Sponsors and Collaborators: |
AstraZeneca Cancer International Research Group |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00637026 |
A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacodynamics Study |
Official Title: | 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. |
Estimated Enrollment: | 65 |
Study Start Date: | July 2003 |
Study Completion Date: | February 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Alison Armour Medical Science Director ) |
Study ID Numbers: | 1839IL/0219 |
Study First Received: | March 10, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00637026 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: Medicines and Healthcare Products Regulatory Agenc; Hungary: National Institute of Pharmacy; Ireland: Ministry of Health; Poland: Ministry of Health |
Iressa, Gefitinib, Breast Cancer, Surgery |
Skin Diseases Breast Neoplasms Protein Kinase Inhibitors Gefitinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Protein Kinase Inhibitors Gefitinib Pharmacologic Actions Breast Diseases |