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Ph II Early BC Pre-Surgical Biologic Study

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 17, 2008
Last Update Posted: April 23, 2009
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.
Cancer International Research Group (CIRG)
Information provided by:
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 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 65
Study Start Date: July 2003
Study Completion Date: February 2005
Intervention Details:
    Drug: Gefitinib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00637026     History of Changes
Other Study ID Numbers: 1839IL/0219
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: April 23, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Iressa, Gefitinib, Breast Cancer, Surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action