SCCA Breast Cancer Clinical Trials
This clinical trial studies F-18 16 alpha-fluoroestradiol (F-18 FES) positron emission tomography (PET) in measuring hormone expression in patients with recurrent or metastatic breast cancer undergoing endocrine-targeted therapy. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.
- Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
- Breast cancer from ER+ primary that is seen on other imaging tests; tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease
- At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging
- Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES
- Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
- Patients must be willing to undergo serial imaging procedures
- Patients must agree to allow access to clinical records regarding response to treatment and long term follow up
- An inability to lie still for the tests
- Individuals weighing more than 300 lb; (this is the weight limit of the scanner table)
- Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded
- 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)
- Use of tamoxifen, Faslodex, diethylstilbestrol (DES) or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan
- Unwillingness or inability to give informed consent
- Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)
- Adult patients who require monitored anesthesia for PET scanning
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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