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

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