Ph II Early BC Pre-Surgical Biologic Study

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637026

Enrollment

Registered

2008-03-17

Start date

2003-07-31

Completion date

2005-02-28

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Iressa, Gefitinib, Breast Cancer, Surgery

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.

Interventions

DRUGGefitinib

Iressa

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026