Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

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: NCT00255463
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : April 23, 2009
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Brief Summary:
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours
Study Start Date : January 2004
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

Secondary Outcome Measures :
  1. Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
  2. Comparison of WHO and RECIST criteria,
  3. Exploratory biomarker studies involving genomics, metabolomics and proteomics.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Measurable (stage I-IIIB) non meta static non inflammatory breast cancer
  • Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as:
  • Natural menopause with last menses > 1 year ago,
  • Radiation induced oophorectomy with last menses > 1 year ago,
  • Serum FSH and LH levels clearly in the postmenopausal range for the institution.
  • Bilateral oophorectomy

Exclusion Criteria:

  • Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities,
  • Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer

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): NCT00255463

Czech Republic
Research Site
Brno, Czech Republic
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Chomutov, Czech Republic
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Ostrava - Poruba, Czech Republic
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Ostrava, Czech Republic
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Praha 2, Czech Republic
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Clermont Ferrand, France
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Montpellier Cedex 5, France
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Tours Cedex, France
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Villejuif Cedex, France
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Budapest, Hungary
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Debrecen, Hungary
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Kecskemet, Hungary
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Coimbra, Portugal
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Funchal, Portugal
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Lisboa, Portugal
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Santiago de Compostela, A Coruña, Spain
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Jaen, Jaén, Spain
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A Coruna, Spain
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Sevilla, Spain
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Valencia, Spain
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Zaragoza, Spain
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Göteborg, Sweden
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Molndal, Sweden
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Stockholm, Sweden
United Kingdom
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Chelmsford, Essex, United Kingdom
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Bournemouth, United Kingdom
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Croydon, United Kingdom
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Dundee, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle Upon Tyne, United Kingdom
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Poole, United Kingdom
Sponsors and Collaborators
Study Director: AstraZeneca Iressa Medical Sciences Director, MD AstraZeneca Identifier: NCT00255463     History of Changes
Other Study ID Numbers: 1839IL/0223
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

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
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs