Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients|
- 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Confirm the wild type status of p53 and analyze the functional status of p53 pathway by monitoring expression of selected p53-target genes in tumors in patients who have or have not been treated with tamoxifen [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|No Intervention: No Intervention|
Active Comparator: Tamoxifen
Tamoxifen 20 mg orally 1x/day for 4 weeks
Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
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 participate.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027416
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60601|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Shicha Kumar, MD||Roswell Park Cancer Institute|