PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Diagnostic procedures, such as PET scans, may help in learning how well hormone
      therapy and trastuzumab work to kill breast cancer cells and allow doctors to plan better
      treatment.

      PURPOSE: This clinical trial is studying how well PET scans work in assessing response to
      treatment in patients receiving hormone therapy or trastuzumab for breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Correlate the percent change in fludeoxyglucose F 18 (FDG)-positron emission tomography
           (PET) standardized uptake value (SUV) and percent change in cell proliferation (as
           assessed by tumor biopsy) during hormonal therapy with tumor response in patients with
           hormone receptor-positive (estrogen receptor or progesterone receptor) breast cancer.

        -  Correlate the percent change in FDG-PET SUV and percent change in cell proliferation (as
           assessed by tumor biopsy) during treatment with trastuzumab (Herceptin®) with tumor
           response in patients with HER-2/neu-positive breast cancer.

        -  Compare the association between two-week changes in cell proliferation rate (as measured
           by FDG-PET and biopsy) in patients treated with an aromatase inhibitor or trastuzumab.

      OUTLINE: Patients are assigned to 1 of 2 groups according to therapy.

        -  Group 1 (patients receiving hormonal therapy): Patients undergo fludeoxyglucose F
           18-positron emission tomography (FDG-PET) scan and may also undergo 16α-fluoroestradiol
           F 18 (FES)-PET scan at baseline (prior to beginning therapy) and FDG-PET scan 2 weeks
           after beginning therapy.

      Blood samples are collected at baseline and at 3 and 6 months after beginning aromatase
      inhibitor therapy. The blood samples are examined for hormone levels, including estradiol,
      estrone, testosterone, follicle-stimulating hormone, and sex hormone-binding globulin.

        -  Group 2 (patients receiving HER-2/neu targeted therapy): Patients undergo biopsy and
           FDG-PET scan at baseline (prior to beginning therapy) and FDG-PET scan 1-2 weeks after
           beginning therapy.

      Some patients undergo a core-needle biopsy 2 weeks after beginning therapy. Biopsies are
      assessed for the following markers: proliferative rate (Ki67), estrogen receptor,
      progesterone receptor, HER-2/neu, epidermal growth factor receptor, androgen receptor, and
      topoisomerase II.

      After completion of study therapy, patients are followed periodically for 6 months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): laboratory biomarker analysis; needle biopsy; positron emission tomography; radionuclide imaging; fludeoxyglucose F 18
Intervention type(s): Other; Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Fluorodeoxyglucose F18
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with primary, recurrent or metastatic breast cancer that is either hormonal
        receptor positive or HER-2/neu positive.
      
Keywords: male breast cancer; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer