Ph II Early BC Pre-Surgical Biologic Study

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637026
• Other study ID #: 1839IL/0219
• Status: Completed
• Phase: Phase 2
• First received: March 10, 2008
• Last updated: April 22, 2009
• Start date: July 2003
• Est. completion date: February 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic GoodsCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: Medicines and Healthcare Products Regulatory AgencHungary: National Institute of PharmacyIreland: Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gefitinib
Iressa

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Cancer International Research Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular alterations occuring in breast cancer tissue following Iressa treatment		At time of diagnosis and time of patient surgery
Secondary	Molecular alterations occurring in normal skin tissue following Iressa treatment		At time of diagnosis and time of patient surgery
Secondary	To correlate molecular changes with pharmacokinetic parameters		At time of diagnosis and time of patient surgery
Secondary	To evaluate tolerability of short term Iressa treatment