Pre-surgical aromatase inhibitor combined with non-steroidal anti inflammatory drug treatment in breast cancer
Phase 2
Recruiting
- Conditions
- post menopausal breast cancerCancer - Breast
- Registration Number
- ACTRN12614000507684
- Lead Sponsor
- niversity of otago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
ER positive, stage 1-2 breast cancer, post-menopausal, no prior therapy
Exclusion Criteria
not post-menopausal, prior breast cancer, other illnesses,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in biological markers, including inflammation and proliferation, over 14 days of treatment. Pre- and post treatment tumour samples will be compared, and studied by immunohistochemistry for immune cell subsets, inflammatory cells, and tumour cell Ki67. Gene expression profiling using the same tumour samples will also be studied at a later stage.[14 days, or day of surgery if this is sooner.]
- Secondary Outcome Measures
Name Time Method safety of aspirin over 14 days, including peri-operatively, by twice weekly nurse assessment before and after surgery, using standard toxicity grading, recorded on CRF for specific side effects of interest.[During 14 days of treatment, on day of surgery and at 4-6 weeks]