Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients
Women with abnormal mammogram or suspicious masses will undergo diagnostic core biopsies
which will be analyzed for ER/PR and HER2Neu expression. For patients that are ER positive,
P53 staining will be done.
Women presenting tumors with an Allred score of 3 or greater status will be approached to
Women will be randomized to either standard of care surgical therapy or a 4 week
intervention of Tamoxifen 20mg daily for 4 weeks prior to surgery. During the intervention,
blood draws will be done to measure levels of tamoxifen metabolites in the blood and test
for polymorphisms that may decrease levels of active metabolites.
Women will undergo two blood draws for PK/PD and one for pharmacogenomics.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Investigate the status of ERά-p53 interaction in ERά-positive, p53-wild type breast tumors in untreated patients and examine how tamoxifen therapy modifies this reaction
Stephen Edge, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
RPCI I 110907
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Chicago||Chicago, Illinois 60637|