Ph II Early BC Pre-Surgical Biologic Study

This study has been completed.
Sponsor:
Collaborator:
Cancer International Research Group
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637026
First received: March 10, 2008
Last updated: April 22, 2009
Last verified: April 2009
  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 2

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


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

Estimated Enrollment: 65
Study Start Date: July 2003
Study Completion Date: February 2005
Intervention Details:
    Drug: Gefitinib
    Iressa
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alison Armour Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00637026     History of Changes
Other Study ID Numbers: 1839IL/0219
Study First Received: March 10, 2008
Last Updated: April 22, 2009
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014