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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255463
First received: November 17, 2005
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.


Condition Intervention Phase
Breast Cancer
Drug: Anastrazole
Drug: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 185
Study Start Date: January 2004
Study Completion Date: November 2005
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255463

Locations
Czech Republic
Research Site
Brno, Czech Republic
Research Site
Chomutov, Czech Republic
Research Site
Ostrava, Czech Republic
Research Site
Ostrava - Poruba, Czech Republic
Research Site
Praha 2, Czech Republic
France
Research Site
Clermont Ferrand, France
Research Site
Montpellier Cedex 5, France
Research Site
Tours Cedex, France
Research Site
Villejuif Cedex, France
Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Kecskemet, Hungary
Portugal
Research Site
Coimbra, Portugal
Research Site
Funchal, Portugal
Research Site
Lisboa, Portugal
Spain
Research Site
Santiago de Compostela, A Coruña, Spain
Research Site
Jaen, Jaén, Spain
Research Site
A Coruna, Spain
Research Site
Sevilla, Spain
Research Site
Valencia, Spain
Research Site
Zaragoza, Spain
Sweden
Research Site
Göteborg, Sweden
Research Site
Molndal, Sweden
Research Site
Stockholm, Sweden
United Kingdom
Research Site
Chelmsford, Essex, United Kingdom
Research Site
Bournemouth, United Kingdom
Research Site
Croydon, United Kingdom
Research Site
Dundee, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle Upon Tyne, United Kingdom
Research Site
Poole, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00255463     History of Changes
Other Study ID Numbers: 1839IL/0223, D7913C00223
Study First Received: November 17, 2005
Last Updated: April 22, 2009
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Gefitinib
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014