F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy

Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-Targeted Therapy

This clinical trial studies use of F-18 16 alpha-fluoroestradiol ([F-18] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

Study Overview

• Status: Terminated
• Conditions: Recurrent Breast Carcinoma; Estrogen Receptor Positive; Stage IV Breast Cancer AJCC v6 and v7
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Drug: F-18 16 Alpha-Fluoroestradiol; Drug: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography

Detailed Description

PRIMARY OBJECTIVES:

I. Measure the effect of endocrine targeted therapy on estrogen receptor (ER) expression and estradiol binding to the receptor using serial FES PET and fludeoxyglucose F-18 (FDG) PET.

SECONDARY OBJECTIVES:

I. Document the safety profile of FES PET in patients with breast cancer.

II. Examine associations between FES PET results and serial measurements of hormone or other levels in peripheral blood, as related to efficacy of endocrine-targeted therapy. Correlate FES PET uptake measures with histopathological assays and tumor microenvironment studies on biopsy specimens, if relevant to specific treatment regimen.

OUTLINE:

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

After completion of study, patients are followed up for up to 20 years.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
• Breast cancer from ER+ primary that is seen on other imaging tests; tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease
• At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging
• Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES
• Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
• Patients must be willing to undergo serial imaging procedures
• Patients must agree to allow access to clinical records regarding response to treatment and long term follow up

Exclusion Criteria:

• An inability to lie still for the tests
• Individuals weighing more than 300 lb; (this is the weight limit of the scanner table)
• Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded
• Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
• Use of tamoxifen, Faslodex, diethylstilbestrol (DES) or any other ER blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan
• Unwillingness or inability to give informed consent
• Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)
• Adult patients who require monitored anesthesia for PET scanning

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: Diagnostic (F-18 FES PET/CT); Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Computed Tomography; Undergo FDG PET/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; tomography; computerized tomography; CT SCAN; Procedure: Positron Emission Tomography; Undergo FDG PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Procedure: Computed Tomography; Undergo F-18 FES PET/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; tomography; computerized tomography; CT SCAN; Drug: F-18 16 Alpha-Fluoroestradiol; Undergo F-18 FES PET/CT; Other Names: 16 alpha-fluroestradiol-17 beta; F-18 FES; FES; Fluorine-18 16 alpha-fluoroestradiol; Fluoroestradiol F-18; Drug: Fludeoxyglucose F-18; Undergo FDG PET/CT; Other Names: 18FDG; FDG; fludeoxyglucose F 18; Fludeoxyglucose F18; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; Fluorodeoxyglucose F18; Procedure: Positron Emission Tomography; Undergo F-18 FES PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV	Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero.	from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)
F-18 16 Alpha-fluoroestradiol (FES) Uptake	Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible.	from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)
Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)	The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval.	from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Disease Progression	Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression,	from start of therapy up to 20 years

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2010
• Primary Completion (Actual): December 27, 2018
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Protective Agents; Radiopharmaceuticals; Cariostatic Agents; Fluorodeoxyglucose F18; Fluorides; Deoxyglucose
• Other Study ID Numbers: 7184 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P01CA042045 (U.S. NIH Grant/Contract); NCI-2013-02342 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U01CA148131 (U.S. NIH Grant/Contract); RG1711032 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No