Ph II Early BC Pre-Surgical Biologic Study

This study has been completed.

First Received: March 10, 2008 Last Updated: April 22, 2009 History of Changes

Sponsors and Collaborators:	AstraZeneca Cancer International Research Group
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00637026

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Gefitinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Pharmacodynamics Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: ZD1839

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Molecular alterations occuring in breast cancer tissue following Iressa treatment [ Time Frame: At time of diagnosis and time of patient surgery ]

Secondary Outcome Measures:

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

Intervention Details:

Iressa

Eligibility

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	AstraZeneca ( Alison Armour Medical Science Director )
Study ID Numbers:	1839IL/0219
Study First Received:	March 10, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00637026 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: Medicines and Healthcare Products Regulatory Agenc; Hungary: National Institute of Pharmacy; Ireland: Ministry of Health; Poland: Ministry of Health

Keywords provided by AstraZeneca:

Iressa, Gefitinib, Breast Cancer, Surgery

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Protein Kinase Inhibitors
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Gefitinib
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on August 12, 2009