Clinical trial NCT00255463: Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 185
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
Secondary outcomes:
measure: Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
measure: Comparison of WHO and RECIST criteria,
measure: Exploratory biomarker studies involving genomics, metabolomics and proteomics.
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Research Site
city: Chomutov
country: Czech Republic
facility: Research Site
city: Ostrava - Poruba
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Tours Cedex
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Funchal
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
state: A Coruña
city: Jaen
country: Spain
facility: Research Site
state: Jaén
city: A Coruna
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Molndal
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
state: Essex
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Croydon
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Poole
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Sciences Director, MD
role: STUDY_DIRECTOR
References: