Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Anastrazole
- Drug: Gefitinib
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
AstraZeneca Iressa Medical Sciences Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00255463
