FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients With Newly Diagnosed Metastatic Breast Cancer
4 other identifiers
interventional
99
1 country
25
Brief Summary
This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2016
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedStudy Start
First participant enrolled
May 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 21, 2026
April 1, 2026
10.2 years
March 25, 2015
April 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease
FES-PET results will be assessed as positive or negative by quantitative or qualitative criteria. FES SUVmax \< 1.5 will be defined as quantitatively negative test result while one or more sites of active disease will be qualitatively negative test result. The reference standard is patient's tumor response categorized by either CB or PD at 6 months. As part of the preliminary analysis, rates of FES uptake negative results overall and next by tumor response status will be calculated. FES-PET test positive results will be compared in the two tumor response groups using a chi-square test.
At 6 months
Secondary Outcomes (8)
Test-retest reproducibility of quantitative assessment of tumor FES uptake by SUVs
Up to 6 months
FES SUVmax
Up to 6 months
Predictive accuracy of FES PET/CT for PFS, defined as the time from entry onto study until tumor progression or death from any cause
Up to 1 year
Significance of FES PET measures in predicting PD or CB, in concert with semi-quantitative interpretation of ER, PgR, and Ki-67
Baseline
FES uptake, as measured by SUVmax and semi-quantitative ER from IHC
Up to 6 months
- +3 more secondary outcomes
Study Arms (1)
Diagnostic (FES PET/CT)
EXPERIMENTALBetween 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.
Interventions
Given IV
Undergo PET/CT
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- Capable and willing to provide informed consent
- Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 7 days prior to FES PET/CT scan and \[18F\]-fluorodeoxyglucose (FDG)-PET/CT scan to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy or
- Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
- Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor \[AI\], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed
- Medically stable as judged by patient's physician
- Life expectancy must be estimated by patient's physician at \> 6 months
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years)
- Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES
- Patient must NOT be in liver failure as judged by the patient's physician
- Histologically confirmed metastatic breast cancer
- Primary tumor and/or metastatic site must be ER+ and may be progesterone-receptor positive (PgR+) or progesterone-receptor negative (PgR-) by IHC; patients with a history of an estrogen-receptor negative (ER-) primary tumor and a documented ER+ metastatic site are eligible
- The pathology report and either (1) tissue (blocks or an unstained slides) or (2) a photomicrograph of the ER IHC slides from at least one site of metastatic disease and/or from primary breast cancer must be available for central review and analysis
- NOTE: if photomicrographs are submitted, the submission of hematoxylin and eosin (H\&E), PR and Ki67 IHC's, if performed, are also to be submitted
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Springmill Medical Center
Indianapolis, Indiana, 46290, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
East Norriton, Pennsylvania, 19401, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Farrokh Dehdashti
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
March 26, 2015
Study Start
May 4, 2016
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04