F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
Condition: Estrogen Receptor-positive Breast Cancer; Progesterone Receptor-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: F-18 16 alpha-fluoroestradiol; fludeoxyglucose F 18; positron emission tomography; positron emission tomography; computed tomography; laboratory biomarker analysis
Intervention description: Undergo [^18F] FES PET; Undergo standard clinical FDG PET/CT; Undergo [^18F] FES PET; Undergo standard clinical FDG PET/CT; Undergo standard clinical 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: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in
      predicting response to first-line hormone therapy in women with hormone receptor-positive
      metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how
      well patients will respond to hormone therapy and may help plan the best treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will have pathologically confirmed invasive breast cancer with clinical,
             radiographic and/or pathologic evidence of stage IV disease; patients must have tissue
             blocks available from biopsy of at least one site of metastatic disease and/or from
             diagnosis of their primary breast cancer

          -  Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST]
             criteria) or non-measurable but must be present in at least one non-liver site and
             imageable on FDG PET scan; in patients with non-measurable disease by RECIST criteria,
             one of the following may be used to assess and follow disease: MUC-1 antigen level
             (either cancer antigen [CA] 27.29 or carcinoembryonic antigen [CEA]) > 2 x upper limit
             of normal (ULN), Circulating tumor cell assay > 5, or FDG-PET SUV > 2.5 in purely
             lytic lesions; elevated tumor markers alone are insufficient

          -  No prior endocrine therapy for breast cancer or

               -  Off adjuvant endocrine therapy for > 6 months or

               -  Greater than 2 years of a single adjuvant endocrine therapy at the time of first
                  recurrence and plan to change to alternate endocrine therapy; use of tamoxifen
                  must be discontinued 6-8 weeks prior to entrance into the study

          -  Prior chemotherapy regimens in the adjuvant or neoadjuvant setting are allowed

          -  Women treated with adjuvant LHRH (luteinizing hormone-releasing hormone) analog are
             eligible

          -  Be assessed for menopausal status; 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

          -  Premenopausal patients must have a baseline FSH, and estradiol levels to determine
             menopausal status; measures will be repeated at 3-6 months to confirm menopausal
             status

          -  Patients must be positive for estrogen receptor (ER) and may or may not be positive
             for progesterone receptor (PgR) by IHC in the primary tumor and/or metastatic site;
             the pathology report for assay of ER will be reviewed by one of the investigators
             prior to enrollment, the study pathologist will review the pathology report if
             necessary for determination of study eligibility

          -  Tumor HER2/neu expression must be determined prior to study enrollment; assessment may
             be by fluorescence in situ hybridization (FISH) assay or by immunohistochemistry
             (ICC); if determination is intermediate by ICC, FISH must be performed

          -  Life expectancy > 16 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Absolute neutrophil count (ANC) >= 1,000

          -  Platelet count >= 50,000

          -  Hemoglobin within normal limits (WNL) for the institution

          -  Serum creatinine =< 1.5 x institutional ULN (IULN) and estimated creatinine clearance
             > 50 mL/min using the Cockroft-Gault formula

          -  Bilirubin =< 1.5 x ULN

          -  Serum glutamic oxaloacetic transaminase (SGOT)/ serum glutamic pyruvate transaminase
             (SGPT) =< 1.5 x ULN

          -  Alkaline phosphatase =< 2.5 x ULN

          -  Patients must be planning a course of endocrine therapy with one of the following:
             tamoxifen +/- ovarian suppression, aromatase inhibitor +/- fulvestrant (with ovarian
             suppression in pre-menopausal patients) or fulvestrant alone

          -  After entry into the study, patients are expected to be followed for at least 6 months
             after the injection of [^18F] FES

          -  Have a negative pregnancy test within 7 days prior to registration if of childbearing
             potential

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer
             from which the patient has been disease-free for 5 years

          -  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

          -  Women of child-bearing potential must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of study participation; should a woman become pregnant or suspect she is pregnant
             while participating in this study, she should inform her treating physician
             immediately

        Exclusion Criteria:

          -  Patients with a history of prior endocrine therapy for metastatic disease are NOT
             eligible; adjuvant endocrine therapy for < 2 years total or discontinued less than 6
             months before first disease recurrence also excludes the patient

          -  Patients with disease in the liver only are NOT eligible for the study

          -  Patients who are HER2/neu positive disease and planning to undergo HER2-directed
             therapy (trastuzumab or lapatinib) are NOT eligible for the study

          -  Pregnant or lactating; women of childbearing potential with either a positive or no
             pregnancy test at baseline are excluded

          -  Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung
             metastases

          -  History of uncontrolled seizures, central nervous system disorders, or psychiatric
             disability judged by the investigator to be clinically significant, precluding
             informed consent

          -  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)

          -  Unwillingness to give informed consent

          -  Medically unstable as judged by the patient's physician

          -  Psychological, familial, sociological, or geographical conditions which do not permit
             compliance with the study protocol

          -  Patients with known allergic or hypersensitivity reactions to previously administered
             radiopharmaceuticals; patients with significant drug or other allergies or autoimmune
             diseases may be enrolled at the investigator's discretion

          -  Patient weight greater than 400 lbs (exceeds weight limit for tomograph table)

          -  Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)

          -  Adult patients who require monitored anesthesia for PET scanning