Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
Phase 2
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT00255463
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 185
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To determine and compare changes in proliferation marker at 16 weeks in the treatment groups
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Research Site
🇬🇧Poole, United Kingdom