Ph II Early BC Pre-Surgical Biologic Study

Study identifier:1839IL/0219

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

Breast Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Gefitinib

Sex

Female

Actual Enrollment

65

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Jul 2003
Primary Completion Date: -
Study Completion Date: 01 Feb 2005

Study design

Allocation: N/A
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Breast Cancer International Research Group

Inclusion and exclusion criteria