Breast Cancer
Conditions
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
Brief 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.
Interventions
OTHERlaboratory biomarker analysis
PROCEDUREneedle biopsy
PROCEDUREpositron emission tomography
PROCEDUREradionuclide imaging
RADIATIONfludeoxyglucose F 18
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks | 2 weeks |
| Percent change in cell proliferation correlated with absolute measures of FDG-PET | 2 weeks |
| Correlation of early FDG-PET with response prediction | 6 months |
Countries
United States
Outcome results
None listed