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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT01027416
• Date of registration: 04/12/2009
• Primary sponsor: Roswell Park Cancer Institute
• Public title: Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
• Scientific title: Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients
• Date of first enrolment: December 2009
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01027416
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: AskRPCI

• Name: Stephen Edge, MD
• Affiliation: Roswell Park Cancer Institute

Key inclusion & exclusion criteria

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 ER? 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 ß-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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Tamoxifen

Primary Outcome(s)

Investigate the status of ER?-p53 interaction in ER?-positive, p53-wild type breast tumors in untreated patients and examine how tamoxifen therapy modifies this reaction [Time Frame: 2 years]

Secondary Outcome(s)

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]

Secondary ID(s)

R21CA137635-01A1

RPCI I 110907

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

National Institutes of Health (NIH)