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Ph II Early BC Pre-Surgical Biologic Study

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ClinicalTrials.gov Identifier: NCT00637026
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : April 23, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Gefitinib
    Iressa

Outcome Measures

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

Eligibility Criteria

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
Criteria

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
More Information

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00637026     History of Changes
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action