Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
Information source: Roswell Park Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Tamoxifen (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Roswell Park Cancer Institute Official(s) and/or principal investigator(s): Shicha Kumar, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute
Overall contact: AskRPCI, Phone: 1-877-275-7724, Email: AskRPCI@roswellpark.org
Summary
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.
Clinical Details
Official title: Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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 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)
Locations and Contacts
AskRPCI, Phone: 1-877-275-7724, Email: AskRPCI@roswellpark.org
University of Chicago, Chicago, Illinois 60601, United States; Recruiting Lucia Gutierrez, Phone: 773-834-7964, Email: lgutierrez2@surgery.bsd.uchicago.edu
Roswell Park Cancer Institute, Buffalo, New York 14263, United States; Recruiting
Additional Information
Starting date: December 2009
Last updated: May 18, 2015
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