Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
NCT ID: NCT01027416
Last Updated: 2017-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2009-12-14
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No Intervention
No interventions assigned to this group
Tamoxifen
Tamoxifen 20 mg orally 1x/day for 4 weeks
Tamoxifen
Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
Interventions
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Tamoxifen
Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
Eligibility Criteria
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Inclusion Criteria
2. The patient must be 18 years or older.
3. Core biopsy should definitively demonstrate invasive carcinoma.
4. Invasive carcinoma should be ER-apha receptor positive
5. 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.
6. Patients in whom surgical excision of the tumor is part of standard of care management
7. ECOG score of 0 or 1
8. 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)
9. Consent to participate in DBBR (RPCI only)
Exclusion Criteria
2. Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.
3. Patients with diagnosis by FNA cytology only
4. Pregnant or lactating women
5. Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy
6. Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible
7. Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision
8. Psychiatric or addictive disorders that would preclude obtaining informed consent
9. Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism
10. Women with non-invasive disease or microinvasion are not eligible.
11. Women undergoing neoadjuvant chemotherapy are not eligible
12. women currently on tamoxifen and raloxifene for prevention are not eligible
13. Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.
14. Patients with a known mutation in p53 (Li Fraumeni Syndrome)
18 Years
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Gokul Das, PhD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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University of Chicago
Chicago, Illinois, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RPCI I 110907
Identifier Type: -
Identifier Source: org_study_id
NCT01658566
Identifier Type: -
Identifier Source: nct_alias