Ph II Early BC Pre-Surgical Biologic Study

AstraZeneca65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

GefitinibDRUG

Iressa

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Molecular alterations occuring in breast cancer tissue following Iressa treatment

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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