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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239343
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : January 27, 2011
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: gefitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2004
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Primary Outcome Measures :
  1. the complete pathological response rate in the two study groups at trial closure

Secondary Outcome Measures :
  1. complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239343

Research Stie
Herlev, Denmark
Research Site
København N, Denmark
Research Site
København Ø, Denmark
Research Site
Vejle, Denmark
Research Site
Århus C, Denmark
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Research Site
Lund, Sweden
Sponsors and Collaborators
Study Director: AstraZeneca Oncology Medical Director, MD AstraZeneca Identifier: NCT00239343     History of Changes
Other Study ID Numbers: 1839IL/0712
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action