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.

AstraZeneca0 sites65 target enrollmentJuly 2003

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: AstraZeneca
Enrollment: 65
Primary Endpoint: Molecular alterations occuring in breast cancer tissue following Iressa treatment
Status: Completed
Last Updated: 17 years ago

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.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

February 2005

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Sponsor

•Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis

•Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa

Molecular alterations occuring in breast cancer tissue following Iressa treatment

Time Frame: At time of diagnosis and time of patient surgery

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