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

NCT02409316 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 821717
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Estrogen Receptor Positive Breast Cancer; Breast Neoplasm; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate [18F]FES PET/CT Uptake

  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

  4 years

Secondary Outcomes (5)

• Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry

  4 years

• Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT

  4 years

• Evaluate Overall Survival in Patients

  4 years

• Compare FES Uptake Measures at Baseline and Progression

  4 years

• Correlate FES uptake measures with number of ER+ Circulating Tumor Cells

  4 years

Study Arms (1)

FES PET/CT

EXPERIMENTAL

All subjects will receive an \[18F\]FES PET/CT scan.

Drug: [18F]FES

Interventions

[18F]FES DRUG

\[18F\]FES PET/CT scan

Also known as: Fluoroestradiol

FES PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

16-fluoroestradiol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Mankoff, MD. PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 6, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)