Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01027416|
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Tamoxifen||Not Applicable|
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. Tissue microarray (TMA) will be generated from resected tumors for immunohistochemistry (IHC) and proximity ligation assay (PLA) for measuring ER alpha-p53 interaction.
Tumor tissue will be used for analyzing tamoxifen metabolites and estradiol levels. RNA and proteins from the tumors will be used for analyzing gene expression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients|
|Actual Study Start Date :||December 14, 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|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
- Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm [ Time Frame: 2 years ]Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm
- Total Number of Over-expressed Genes, Across All Participants With Tumor Protein p53-wild Type Breast Tumors That Had RNA Samples Available. [ Time Frame: 2 years ]Total number of over-expressed genes, across all participants with tumor protein p53-wild type breast tumors that had ribonucleic acid (RNA) samples available.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:||Gokul Das, PhD||Roswell Park Cancer Institute|