[18F]FES PET/CT in Endocrine Refractory Breast Cancer
Primary Purpose
Estrogen Receptor Positive Breast Cancer, Breast Neoplasm, Metastatic Breast Cancer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[18F]FES
Sponsored by
About this trial
This is an interventional diagnostic trial for Estrogen Receptor Positive Breast Cancer
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FES PET/CT
Arm Description
All subjects will receive an [18F]FES PET/CT scan.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Evaluate Overall Survival in Patients
Evaluate overall survival in patients receiving regimens containing endocrine targeted therapy
Compare FES Uptake Measures at Baseline and Progression
Compare FES uptake measures at baseline and progression in patients receiving additional endocrine targeted therapy
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
Full Information
NCT ID
NCT02409316
First Posted
March 31, 2015
Last Updated
July 6, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02409316
Brief Title
[18F]FES PET/CT in Endocrine Refractory Breast Cancer
Official Title
[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo ER in Endocrine Refractory Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Estrogen Receptor Positive Breast Cancer, Breast Neoplasm, Metastatic Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FES PET/CT
Arm Type
Experimental
Arm Description
All subjects will receive an [18F]FES PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
[18F]FES
Other Intervention Name(s)
Fluoroestradiol
Intervention Description
[18F]FES PET/CT scan
Primary Outcome Measure Information:
Title
Evaluate [18F]FES PET/CT Uptake
Description
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
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry
Description
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
Time Frame
4 years
Title
Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT
Description
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
Time Frame
4 years
Title
Evaluate Overall Survival in Patients
Description
Evaluate overall survival in patients receiving regimens containing endocrine targeted therapy
Time Frame
4 years
Title
Compare FES Uptake Measures at Baseline and Progression
Description
Compare FES uptake measures at baseline and progression in patients receiving additional endocrine targeted therapy
Time Frame
4 years
Title
Correlate FES uptake measures with number of ER+ Circulating Tumor Cells
Description
Correlate FES uptake measures with number of ER+ Circulating Tumor Cells (CTCs) and ratio of ER+ to ER- CTCs
Time Frame
4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mankoff, MD. PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
[18F]FES PET/CT in Endocrine Refractory Breast Cancer
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