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Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01027416
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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Brief Summary:
This study will help to understand the interaction between estrogen receptor-alpha (ER alpha) and tumor suppressor protein p53 as well as impact on patient tumor gene expression in response to the hormonal therapy Tamoxifen. This information may eventually help select the appropriate therapy for future patients with similar cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Tamoxifen Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
No Intervention: No Intervention
Active Comparator: Tamoxifen
Tamoxifen 20 mg orally 1x/day for 4 weeks
 Drug: Tamoxifen
Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines
  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:

  1. Male patients are not eligible for this study
  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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Roswell Park Cancer Institute
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gokul Das, PhD Roswell Park Cancer Institute
  Study Documents (Full-Text)

Documents provided by Roswell Park Cancer Institute:
Study Protocol and Statistical Analysis Plan  [PDF] December 23, 2016

More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01027416    
Obsolete Identifiers: NCT01658566
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
Keywords provided by Roswell Park Cancer Institute:
ER positive
Tamoxifen
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents