This study is being offered to patients who are post-menopausal, have breast cancer with a positive estrogen and/or progesterone hormone receptor test and are currently awaiting surgery for breast cancer. The purpose of this study is to determine whether abiraterone acetate has different hormonal and genomic effects than non-steroidal aromatase inhibitors in the treatment of post-menopausal hormonal receptor positive primary operable breast cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
London Regional Cancer Program
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Segal Cancer Centre
Montreal, Quebec, Canada
Differences in genomic expression and biological activity
To determine the differences in genomic expression changes with 2 weeks of abiraterone acetate plus prednisone relative to changes with 2 weeks of an aromatase inhibitor as a means to assess for potential differences in biological activity between abiraterone acetate and aromatase inhibitors in breast cancer
Time frame: 2 weeks (baseline and day 14)
Change in proliferation
To compare the magnitude in change in proliferation (Ki67 as measured by IHC) with abiraterone acetate plus prednisone relative to changes in proliferation with an aromatase inhibitor following 2 weeks of pre-operative therapy
Time frame: 2 weeks (baseline and day 14)
Resulting adverse events of two weeks of abiraterone acetate
To evaluate the safety of two weeks of abiraterone acetate plus prednisone in this pre-operative population of patients. Safety analyses will analyze treatment-emergent adverse events coded using MedDRA resulting in death, serious adverse events, discontinuation, modification and dose interruption or day. Other safety endpoints include vital signs and clinical laboratory parameters.
Time frame: 2 weeks (baseline and day 14)
Changes in plasma hormone levels
To evaluate the changes in plasma hormone levels (androgens and estrogens) from baseline to after 2 weeks of abiraterone acetate plus prednisone
Time frame: 2 weeks (baseline and day 14)
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