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Clinical Trials/NCT00255463
NCT00255463CompletedPhase 2

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

AstraZeneca34 sites in 7 countries185 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
185
Locations
34
Primary Endpoint
To determine and compare changes in proliferation marker at 16 weeks in the treatment groups

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Comparison of WHO and RECIST criteria,
  • Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate.
  • Exploratory biomarker studies involving genomics, metabolomics and proteomics.

Investigators

Sponsor Class
Industry

Study Sites (34)

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