Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients
I. Investigate the status of ERalpha-p53 interaction in ERalpha-positive, p53-wild type
breast tumors in untreated patients and examine how tamoxifen (tamoxifen citrate) therapy
modifies this interaction.
II. To 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.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive standard of care surgical therapy. Patients may undergo standard
Arm II: Patients receive tamoxifen citrate orally (PO) daily for 4 weeks in the absence of
disease progression or unacceptable toxicity. Patients may then undergo standard surgery.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparisons of ERalpha-p53 interaction (positive or negative) between independent treatment and control groups
The proportions of patients with positive ChIP assay will be compared with Fisher's Exact Test. Descriptive statistics such as frequencies and relative frequencies will be computed for all categorical variables. Numeric variables will be summarized using simple descriptive statistics such as mean, standard deviation, quartiles, etc. Ninety-five percent confidence intervals will be computed when appropriate.
Roswell Park Cancer Institute
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Chicago||Chicago, Illinois 60637|