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Ph II Early BC Pre-Surgical Biologic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637026
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : April 23, 2009
Cancer International Research Group (CIRG)
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Gefitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2003
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gefitinib

Intervention Details:
  • Drug: Gefitinib

Primary Outcome Measures :
  1. Molecular alterations occuring in breast cancer tissue following Iressa treatment [ Time Frame: At time of diagnosis and time of patient surgery ]

Secondary Outcome Measures :
  1. Molecular alterations occurring in normal skin tissue following Iressa treatment [ Time Frame: At time of diagnosis and time of patient surgery ]
  2. To correlate molecular changes with pharmacokinetic parameters [ Time Frame: At time of diagnosis and time of patient surgery ]
  3. To evaluate tolerability of short term Iressa treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Responsible Party: Alison Armour Medical Science Director, AstraZeneca Identifier: NCT00637026    
Other Study ID Numbers: 1839IL/0219
First Posted: March 17, 2008    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009
Keywords provided by AstraZeneca:
Iressa, Gefitinib, Breast Cancer, Surgery
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action