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

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02409316
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
108
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
[18F]Fluoroestradiol (FES) PET/CT Imaging to Evaluate in Vivo ER in Endocrine Refractory Metastatic Breast Cancer
Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate [18F]FES PET/CT Uptake [4 years]

      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

    1. Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry [4 years]

      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

    2. Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT [4 years]

      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

    3. Evaluate Overall Survival in Patients [4 years]

      Evaluate overall survival in patients receiving regimens containing endocrine targeted therapy

    4. Compare FES Uptake Measures at Baseline and Progression [4 years]

      Compare FES uptake measures at baseline and progression in patients receiving additional endocrine targeted therapy

    5. Correlate FES uptake measures with number of ER+ Circulating Tumor Cells [4 years]

      Correlate FES uptake measures with number of ER+ Circulating Tumor Cells (CTCs) and ratio of ER+ to ER- CTCs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT02409316
    Other Study ID Numbers:
    • 821717
    • NCT02559544
    First Posted:
    Apr 6, 2015
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 7, 2022