Philadelphia, Pennsylvania 19104


Purpose:

Evaluate [18F]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy.


Criteria:

Inclusion Criteria: 1. At least 18 years of age 2. Recurrent or metastatic cancer that is of known or suspected breast origin - may be biopsy proven or identified on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT) 3. History of ER+ pathology (ER+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required) 4. At least one site of disease outside of the liver that is seen on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT); patients with measurable or nonmeasurable disease are allowed. 5. History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening 6. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: 1. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 4. History of HER2/neu positive cancer (IHC 3+ and/or FISH positive) as assessed by medical record review at screening


NCT ID:

NCT02559544


Primary Contact:

Principal Investigator
David Mankoff, MD
Abramson Cancer Center of the University of Pennsylvania

David Mankoff, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States

David Mankoff, MD
Phone: 855-216-0098
Email: PennCancerTrials@emergingmed.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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