Oncology Clinical Trial Finder
Breast Cancer

Active, not recruiting • Phase II • Stage IV • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

[18F]FES PET/CT in Endocrine Refractory Breast Cancer

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer [18F]fluoroestradiol (FES).

This study will 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. Imaging will occur prior to starting new therapy. Some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures. This is an observational study in that [18F]FES PET/CT will not be used to direct therapy decisions.

Breast Cancer

Study Design
Study type:


Estimated enrollment:

6 participant

Actual study start date:

May 20, 2015

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:


Arms and Intervention
  • [18F]FES

Inclusion criteria
  • at least 18 years of age

  • 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)

  • 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)

  • 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.

  • 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

  • participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion criteria
  • 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.

  • inability to tolerate imaging procedures in the opinion of an investigator or treating physician

  • 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.

  • history of her2/neu positive cancer (ihc 3+ and/or fish positive) as assessed by medical record review at screening

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Active, not recruiting

Estimated Enrollment:


Last Updated:


Principal Investigator

David Mankoff, MD. PhD

Trial Sponsor

University of Pennsylvania

Study Location (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States


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