NCT00637026

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

March 10, 2008

Last Update Submit

April 22, 2009

Conditions

Breast Cancer

Keywords

Iressa, Gefitinib, Breast Cancer, Surgery

Outcome Measures

Primary Outcomes (1)

  • Molecular alterations occuring in breast cancer tissue following Iressa treatment

    At time of diagnosis and time of patient surgery

Secondary Outcomes (3)

  • Molecular alterations occurring in normal skin tissue following Iressa treatment

    At time of diagnosis and time of patient surgery

  • To correlate molecular changes with pharmacokinetic parameters

    At time of diagnosis and time of patient surgery

  • To evaluate tolerability of short term Iressa treatment

Interventions

GefitinibDRUG

Iressa

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis

You may not qualify if:

  • Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 17, 2008

Study Start

July 1, 2003

Study Completion

February 1, 2005

Last Updated

April 23, 2009

Record last verified: 2009-04