FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

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

FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

What this study is about

FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

What this study is about