Stage IIIA Breast Cancer Clinical Trial
Official title:
Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET
Verified date | April 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 20, 2015 |
Est. primary completion date | July 20, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III - Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study - Have tissue block available from core biopsy for correlative biomarkers and genomic assay - Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as - A prior documented bilateral oophorectomy, or - A history of at least 12 months without spontaneous menstrual bleeding, or - Age 60 or older with a prior hysterectomy without oophorectomy, or - Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab - Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients - Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed - Be a candidate for [18F]FLT PET imaging - Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures - Be willing and able to comply with scheduled visits and other trial procedures Exclusion Criteria: - Current use of aromatase inhibitor as prevention or treatment for breast cancer - Life expectancy of less than two months - HER2/neu positive by IHC and/or another FDA approved HER2 testing method - Inability to tolerate scanning (e.g. - claustrophobia, severe pain) - Weight exceeding capacity of imaging table |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Post-treatment Gene Expression Levels | Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures. | 1 to 6 weeks post-therapy start | |
Other | Pre-treatment Gene Expression Levels | Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures. | Baseline | |
Primary | 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. |
Baseline to up to 6 weeks | |
Primary | 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. | Baseline to up to 6 weeks | |
Primary | 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. | 1 to 6 weeks post-therapy start | |
Primary | 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. |
Baseline to up to 6 weeks | |
Secondary | 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. | Baseline to up to 6 weeks | |
Secondary | 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 | Baseline | |
Secondary | 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 | Baseline | |
Secondary | Baseline Standardized Uptake Values (SUV) by FLT PET | FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET | Baseline | |
Secondary | Post-therapy Ki (Flux Constant) Values by FLT PET | Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET | 1 to 6 weeks post-therapy start | |
Secondary | 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 | 1 to 6 weeks post-therapy start | |
Secondary | Post-treatment Standardized Uptake Values (SUV) by FLT PET | FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET | 1 to 6 weeks post-therapy start |
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