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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- 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
Study Sites (34)
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