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

[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo ER in Endocrine Refractory Metastatic 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasm; Metastatic Breast Cancer; Estrogen Receptor Positive Breast Cancer
• Intervention / Treatment: Drug: [18F]FES

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES PET/CT; All subjects will receive an [18F]FES PET/CT scan.	Drug: [18F]FES; [18F]FES PET/CT scan; Other Names: Fluoroestradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry	Correlate [18F]FES uptake measures with standard immunohistochemistry (IHC) (e.g. ER, PR, HER2-neu) and experimental pathology markers available from primary and/or metastatic tissue	4 years
Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT	Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT in identifying heterogeneity of estrogen receptor expression and functionality in metastatic breast cancer	4 years
Evaluate Overall Survival in Patients	Evaluate overall survival in patients receiving regimens containing endocrine targeted therapy	4 years
Compare FES Uptake Measures at Baseline and Progression	Compare FES uptake measures at baseline and progression in patients receiving additional endocrine targeted therapy	4 years
Correlate FES uptake measures with number of ER+ Circulating Tumor Cells	Correlate FES uptake measures with number of ER+ Circulating Tumor Cells (CTCs) and ratio of ER+ to ER- CTCs	4 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: David Mankoff, MD. PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimated): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 821717