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

April 22, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

185

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • 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
        • Research Site
  • France
      • Clermont Ferrand, France
        • Research Site
      • Montpellier Cedex 5, France
        • Research Site
      • Tours Cedex, France
        • Research Site
      • Villejuif Cedex, France
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Research Site
      • Funchal, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
  • Spain
      • A Coruna, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain
        • Research Site
    • Jaén
      • Jaen, Jaén, Spain
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Molndal, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • United Kingdom
      • 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
        • Research Site
    • Essex
      • Chelmsford, Essex, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Iressa Medical Sciences Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0223
  • D7913C00223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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