Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy
Condition: Estrogen Receptor Positive; Primary or Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7
MeSH terms: Breast Neoplasms
Intervention: F-18 16 Alpha-Fluoroestradiol; Positron Emission Tomography; Computed Tomography; Fludeoxyglucose F-18; Positron Emission Tomography; Computed Tomography; Laboratory Biomarker Analysis
Intervention description: Undergo F-18 FES PET/CT; Undergo F-18 FES PET/CT; Undergo F-18 FES PET/CT; Undergo FDG PET/CT; Undergo FDG PET/CT; Undergo FDG PET/CT; Correlative studies
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies use of F-18 16 alpha-fluoroestradiol ([F-18] FES) positron
      emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor
      expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast
      cancer or breast cancer that has come back or spread to other places in the body. Comparing
      results of diagnostic procedures done before, during, and after hormone therapy may help
      measure a patient's response to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, non-pregnant patients with biopsy-proven or clinically obvious primary,
             recurrent or metastatic breast cancer

          -  Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER
             expression must have been confirmed by immunohistocytochemistry of primary tumor or
             recurrent disease.

          -  At least one site of disease 1.5 cm or greater is needed to meet the spatial
             resolution limits of PET imaging.

          -  Patients must have been off tamoxifen or other estrogen receptor blocking agents for
             at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES.

          -  Patients must be selected for an endocrine targeted therapy regimen for treatment of
             their breast cancer by the referring oncologist. Selected treatments may be part of
             experimental treatment protocols for which the patient would be separately consented.

          -  Patients must be willing to undergo serial imaging procedures.

          -  Patients must agree to allow access to clinical records regarding response to
             treatment and long term follow up.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  An inability to lie still for the tests

          -  Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)

          -  Pregnant or lactating. Women of childbearing potential with either a positive or no
             pregnancy test at baseline are excluded.

          -  Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or
             clinically significant cardiac disease - congestive heart failure, symptomatic
             coronary artery disease, cardiac arrhythmia not well controlled with medication).

          -  Use of tamoxifen, faslodex, DES or any other ER blocking agent < 6 weeks or
             chemotherapy < 3 weeks prior to imaging scan.

          -  Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)

          -  Adult patients who require monitored anesthesia for PET scanning.