Trial record 1 of 1 for:    NCT01027416
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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. Identifier: NCT01027416
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

December 4, 2009
December 8, 2009
October 10, 2017
December 13, 2017
December 13, 2017
December 14, 2009
December 2015   (Final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT01027416 on Archive Site
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.
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 ]
Not Provided
Not Provided
Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Tamoxifen
Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
  • No Intervention: No Intervention
  • Active Comparator: Tamoxifen
    Tamoxifen 20 mg orally 1x/day for 4 weeks
    Intervention: Drug: Tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2015
December 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
RPCI I 110907
R21CA137635-01A1 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Gokul Das, PhD Roswell Park Cancer Institute
Roswell Park Cancer Institute
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP