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Completed

NCT Number: NCT00637026

Ph II Early BC Pre-Surgical Biologic Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Iressa

Primary outcomes

  1. Molecular alterations occuring in breast cancer tissue following Iressa treatment

    Time frame: At time of diagnosis and time of patient surgery

Secondary outcomes

  1. Molecular alterations occurring in normal skin tissue following Iressa treatment

    Time frame: At time of diagnosis and time of patient surgery

  2. To correlate molecular changes with pharmacokinetic parameters

    Time frame: At time of diagnosis and time of patient surgery

  3. To evaluate tolerability of short term Iressa treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Cancer International Research Group (CIRG)

Registry information

Official study 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.

Important dates

Study start
2003
Study completion
2005
First posted
Mar 17, 2008
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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