pet scans in assessing response to treatment in patients receiving hormone therapy or trastuzumab for breast cancer

Conditions: 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.

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 criteria:
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

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