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Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients

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

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.

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

- 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

- 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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Stephen Edge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

RPCI I 110907



Start Date:

December 2009

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • ER positive
  • Tamoxifen
  • Breast Neoplasms



Roswell Park Cancer InstituteBuffalo, New York  14263
University of ChicagoChicago, Illinois  60637