Ph II Early BC Pre-Surgical Biologic Study

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00637026
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study Completion: 2005-02
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-17
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Molecular alterations occuring in breast cancer tissue following Iressa treatment	At time of diagnosis and time of patient surgery

Secondary Outcome Measures

Name	Time	Method
Molecular alterations occurring in normal skin tissue following Iressa treatment	At time of diagnosis and time of patient surgery
To correlate molecular changes with pharmacokinetic parameters	At time of diagnosis and time of patient surgery
To evaluate tolerability of short term Iressa treatment