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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255463
• Other study ID #: 1839IL/0223
• Secondary ID: D7913C00223
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2005
• Last updated: April 22, 2009
• Start date: January 2004
• Est. completion date: November 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Anastrazole

• Gefitinib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Czech Republic,  France,  Hungary,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Secondary	Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
Secondary	Comparison of WHO and RECIST criteria,
Secondary	Exploratory biomarker studies involving genomics, metabolomics and proteomics.