This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES: I. Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy. SECONDARY OBJECTIVES: I. Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen. II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy. OUTLINE: Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
28
Undergo FLT PET
Undergo FLT PET
Correlative studies
Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Percent Change in Net Influx Constant (Ki) by FLT PET
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed. Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Time frame: Baseline to up to 6 weeks
Percent Change in SUV by FLT PET
Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.
Time frame: Baseline to up to 6 weeks
Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample
Surgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.
Time frame: 1 to 6 weeks post-therapy start
Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens
Tumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation. The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient. Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.
Time frame: Baseline to up to 6 weeks
Percentage Change in K1 (Blood Flow Parameter) by FLT PET
Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.
Time frame: Baseline to up to 6 weeks
Baseline Ki (Flux Constant) Values by FLT PET
Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan
Time frame: Baseline
Baseline FLT Transport (K1) Values by FLT PET
K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Time frame: Baseline
Baseline Standardized Uptake Values (SUV) by FLT PET
FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET
Time frame: Baseline
Post-therapy Ki (Flux Constant) Values by FLT PET
Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET
Time frame: 1 to 6 weeks post-therapy start
Post-treatment FLT Transport (K1) Values by FLT PET
K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET
Time frame: 1 to 6 weeks post-therapy start
Post-treatment Standardized Uptake Values (SUV) by FLT PET
FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET
Time frame: 1 to 6 weeks post-therapy start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.