NCT00239343

Brief Summary

The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Oct 2004

Geographic Reach
3 countries

8 active sites

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

October 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

2.6 years

First QC Date

October 14, 2005

Last Update Submit

January 25, 2011

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • the complete pathological response rate in the two study groups at trial closure

Secondary Outcomes (1)

  • complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population

Interventions

gefitinibDRUG

Eligibility Criteria

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

You may qualify if:

  • histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.

You may not qualify if:

  • any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Århus C, Denmark

Location

Research Stie

Herlev, Denmark

Location

Research Site

København N, Denmark

Location

Research Site

København Ø, Denmark

Location

Research Site

Vejle, Denmark

Location

Research Site

Oslo, Norway

Location

Research Site

Trondheim, Norway

Location

Research Site

Lund, Sweden

Location

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 Officials

  • AstraZeneca Oncology Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 17, 2005

Study Start

October 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

NO(2)SE(1)DK(5)