Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

This study has been completed.

First Received: October 14, 2005 Last Updated: December 16, 2007 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00239343

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: gefitinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomised Placebo-Controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	160
Study Start Date:	October 2004
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0.

Eligible for surgery, WHO performance score 0-1.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239343

Locations

Denmark
Research Site
Århus C, Denmark
Research Stie
Herlev, Denmark
Research Site
København N, Denmark
Research Site
København Ø, Denmark
Research Site
Vejle, Denmark
Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Sweden
Research Site
Lund, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Oncology Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	1839IL/0712
Study First Received:	October 14, 2005
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00239343 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Estrogens
Skin Diseases
Breast Neoplasms
Cyclophosphamide

Protein Kinase Inhibitors
Epirubicin
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Gefitinib
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009