Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer

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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed breast cancer with 1 of the following:
  -  Hormone receptor-positive disease and planning to receive treatment with neoadjuvant aromatase inhibitor and ovarian suppression therapy (if premenopausal)
  -  Recurrent and/or metastatic hormone receptor-positive disease and planning to receive treatment with an aromatase inhibitor and ovarian suppression therapy (if premenopausal)
  -  Metastatic HER-2/neu-positive disease and planning to receive treatment with neoadjuvant trastuzumab (Herceptin®)
  -  Recurrent HER-2/neu-positive disease and planning to receive treatment with trastuzumab (Herceptin®)
  -  Tumor must be accessible for biopsy and assessable for response
  -  Tissue block must be available for review of experimental markers or patient must be willing to undergo biopsy
  -  Evaluable disease by FDG-PET scan
  -  Available for positron emission tomography (PET) imaging with a clinical indication for PET scan
  -  May aslo be enrolled on an experimental nuclear imaging study of 16α-fluoroestradiol F 18-PET scan (if hormone positive)
  -  Concurrently receiving treatment (hormonal or other) for breast cancer
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  -  Female or male
  -  Postmenopausal or premenopausal
  -  Life expectancy ≥ 2 months
  -  No uncontrolled diabetes mellitus or other comorbidity that would preclude imaging
  -  Not pregnant
  -  Negative pregnancy test
  -  Able to tolerate scanning (e.g., no claustrophobia or severe pain)
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent participation on another clinical study or other imaging studies allowed

Relevance to patient case: not relevant