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

This study has been completed.
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: December 4, 2009
Last updated: January 8, 2016
Last verified: January 2016
This study will help to understand the interaction between the hormonal therapy Tamoxifen, estrogen receptors and certain genes in the cancer cell. This information may eventually help select the appropriate therapy for future patients with similar cancer.

Condition Intervention
Breast Cancer
Drug: Tamoxifen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: December 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 ERά receptor positive
  • The tumor should be approximately 1 cm, but at least 5mm to account for variability in imaging and imaging occult disease(physical exam, mammography, ultrasound).
  • Patients in whom surgical excision of the tumor is part of standard of care management
  • ECOG of 0 or 1
  • Negative serum or urine β-hCG pregnancy test at screening for patients of child-bearing potential(this is routinely done if premenopausal and having surgery)
  • Consent to participate in DBBR

Exclusion Criteria:

  • Male patients are not eligible for this study
  • Female patients with inoperable tumor and patients undergoing neo-adjuvant chemotherapy
  • Patients with diagnosis by FNA cytology
  • Pregnant or lactating women
  • Prior therapy for breast cancer, including irradiation, chemo-, immuno- and/or hormonal therapy
  • Patients receiving any hormonal therapy, e.g., birth-control pills, ovarian hormonal replacement therapy, infertility medications, etc. are not eligible
  • Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patients 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 history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism
  • Women who are post-menopausal defined as no menses for at least 12 months
  • Women on selective serotonin reuptake inhibitors (SSRI) SSRI inhibits metabolism of tamoxifen
  • Women with non-invasive disease or microinvasion are not eligible
  • Women undergoing neoadjuvant chemotherapy are not eligible
  • Women currently on tamoxifen 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
Roswell Park Cancer Institute
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: Shicha Kumar, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01027416     History of Changes
Obsolete Identifiers: NCT01658566
Other Study ID Numbers: RPCI I 110907  R21CA137635-01A1 
Study First Received: December 4, 2009
Last Updated: January 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
ER positive

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses processed this record on May 03, 2016