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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Anastrazole
• Drug: Gefitinib

Primary Measures

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

Secondary 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.

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Iressa Medical Sciences Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00255463

Study ID Number: 1839IL/0223

ClinicalTrials.gov Identifier: NCT00255463

Health Authority: Sweden: Medical Products Agency