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

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ClinicalTrials.gov Identifier: NCT02409316
Recruitment Status : Recruiting
First Posted : April 6, 2015
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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
Estrogen Receptor Positive Breast Cancer Breast Neoplasm Metastatic Breast Cancer Drug: [18F]FES 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Evaluate overall survival in patients receiving regimens containing endocrine targeted therapy [ Time Frame: 4 years ]
  4. Compare FES uptake measures at baseline and progression in patients receiving additional endocrine targeted therapy [ Time Frame: 4 years ]
  5. Correlate FES uptake measures with number of ER+ Circulating Tumor Cells (CTCs) and ratio of ER+ to ER- CTCs [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409316


Contacts
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Contact: Theresa Berger 215-746-2813 Theresa.berger@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 erin.schubert@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Theresa Berger    215-746-2813    Theresa.berger@uphs.upenn.edu   
Contact: Erin Schubert    215-573-6569    erin.schubert@uphs.upenn.edu   
Principal Investigator: David Mankoff, MD, PHD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: David Mankoff, MD. PhD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02409316    
Obsolete Identifiers: NCT02559544
Other Study ID Numbers: 821717
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases