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
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines
- The patient must be 18 years or older.
- Core biopsy should definitively demonstrate invasive carcinoma.
- Invasive carcinoma should be ER-apha receptor positive
- The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.
- Patients in whom surgical excision of the tumor is part of standard of care management
- ECOG score of 0 or 1
- Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)
- Consent to participate in DBBR (RPCI only)
- Male patients are not eligible for this study
- Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.
- Patients with diagnosis by FNA cytology only
- Pregnant or lactating women
- Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy
- Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision
- Psychiatric or addictive disorders that would preclude obtaining informed consent
- Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism
- Women with non-invasive disease or microinvasion are not eligible.
- Women undergoing neoadjuvant chemotherapy are not eligible
- women currently on tamoxifen and raloxifene for prevention are not eligible
- Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.
- Patients with a known mutation in p53 (Li Fraumeni Syndrome)
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|
Documents provided by Roswell Park Cancer Institute:
|Responsible Party:||Roswell Park Cancer Institute|
|Other Study ID Numbers:||
RPCI I 110907
R21CA137635-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||December 8, 2009 Key Record Dates|
|Results First Posted:||December 13, 2017|
|Last Update Posted:||December 13, 2017|
|Last Verified:||November 2017|
Neoplasms by Site
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents