N/A
Completed N=28
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
Estrogen Receptor Positive · HER2/Neu Negative · Male Breast Carcinoma · Stage IA Breast Cancer
Source: ClinicalTrials.gov NCT01928186 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Percent Change in Net Influx Constant (Ki) by FLT PET — -32.0 % change — p=0.51
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Net Influx Constant (Ki) by FLT PET |
-32.0 | 0.51 |
| PRIMARY Percent Change in SUV by FLT PET |
-26.6 | — |
| PRIMARY Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample |
3 | — |
| PRIMARY Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens |
-80.0 | — |
| SECONDARY Percentage Change in K1 (Blood Flow Parameter) by FLT PET |
-6.2 | — |
| SECONDARY Baseline Ki (Flux Constant) Values by FLT PET |
0.015 | — |
| SECONDARY Baseline FLT Transport (K1) Values by FLT PET |
0.0501 | — |
| SECONDARY Baseline Standardized Uptake Values (SUV) by FLT PET |
2.5 | — |
| SECONDARY Post-therapy Ki (Flux Constant) Values by FLT PET |
0.0142 | — |
| SECONDARY Post-treatment FLT Transport (K1) Values by FLT PET |
0.0675 | — |
| SECONDARY Post-treatment Standardized Uptake Values (SUV) by FLT PET |
1.76 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01928186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.