Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
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
2 other identifiers
interventional
185
7 countries
34
Brief Summary
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2004
Shorter than P25 for phase_2 breast-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedApril 23, 2009
April 1, 2009
November 17, 2005
April 22, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Secondary Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Brno, Czechia
Research Site
Chomutov, Czechia
Research Site
Ostrava, Czechia
Research Site
Ostrava - Poruba, Czechia
Research Site
Prague, Czechia
Research Site
Clermont-Ferrand, France
Research Site
Montpellier, France
Research Site
Tours, France
Research Site
Villejuif, France
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Kecskemét, Hungary
Research Site
Coimbra, Portugal
Research Site
Funchal, Portugal
Research Site
Lisbon, Portugal
Research Site
Santiago de Compostela, A Coruña, Spain
Research Site
Jaén, Jaén, Spain
Research Site
Seville, Sevilla, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Zaragoza, Zaragoza, Spain
Research Site
A Coruña, Spain
Research Site
Gothenburg, Sweden
Research Site
Mölndal, Sweden
Research Site
Stockholm, Sweden
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Iressa Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 21, 2005
Study Start
January 1, 2004
Study Completion
November 1, 2005
Last Updated
April 23, 2009
Record last verified: 2009-04