Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients

Stopped early

Conditions studied: Metastatic Breast Cancer

In brief

This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna PET/CT scan. The treating physician will complete a standardized questionnaire to indicate the second-line therapeutic management plan before the scheduled Cerianna PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine physician, the treating physician will fill out a similar questionnaire to specify the final therapeutic decision. The proportion of patients with a change in therapeutic management plan based on Cerianna PET/CT results will be the primary endpoint. During the study follow-up period of 18 months, data on standard-of-care imaging, treatments/procedures received, and clinical outcomes will be collected. Patients will be asked to complete a health-related quality of life questionnaire at their screening, 6-month, and 18-month visit. Secondary endpoints include visual and quantitative heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18 months after Cerianna PET/CT, which will be assessed between patients with and without a change in therapeutic management plan. Maximum duration of follow-up for each patient: 20 months. First patient first visit to last patient last visit: estimated 36 months.

Key facts

Study ID: NCT05068726
Run by: GE Healthcare
People needed: 51
Starts: 2023-01-05
Expected to finish: 2024-06-01
Last updated by the study team: 2024-07-31

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patient must sign informed consent prior to enrollment in this trial
The patient is a female ≥18 years old
Post-menopausal or pre-menopausal patient with known primary breast tumor(s) expressing ER in ≥1% of tumor cells by IHC
HER2-negative (0, 1+, 2+ fluorescence in situ hybridization (FISH) negative) primary lesion
MBC with at least 1 identifiable lesion on standard-of-care imaging assessment, outside of the liver, as confirmed by the investigator site
Patient with progressive disease on 1st line hormonal therapy (Aromatase Inhibitor) with or without a CDK4/6 inhibitor or mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinases (PI3K) inhibitor
Patient must score at least 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
Life expectancy of at least 12 months
The patient is planned to undergo a standard-of-care imaging scan (according to National Comprehensive Cancer Network guidelines, e.g., CT and/or bone scan, or fluorodeoxyglucose [FDG]-PET/CT) covering chest, abdomen, and pelvis after date of consent and before Cerianna PET/CT (Visit 2), or the patient has undergone recent standard-of-care imaging before date of consent and is planned to undergo Cerianna PET/CT (Visit 2) no more than 45 days from the standard-of-care imaging scan

You may not qualify if…

Isolated hepatic metastases (taking into account the physiological hepatic high uptake of Cerianna)
Patient is on tamoxifen/toremifene treatment without 8-week washout, or on fulvestrant treatment without 28-week washout, (may block ER) before Cerianna PET/CT
Other evolutive malignant disease (non-melanoma skin cancer is allowed) or acute or chronic infectious disease (well-controlled infectious disease is allowed);
Patient has a history of administered chemotherapy for metastatic disease; prior chemotherapy in the (neo)adjuvant setting is allowed
Patient with a known allergy to any of the components of Cerianna
Woman of childbearing age who is not using effective contraception
Pregnant woman (per the Product Label and ensured using clinic's standard-of-care), or parturient or nursing mother
Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of <12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason
Inability to comply with any requirements of the protocol

Where it is running

Northern Arizona Healthcare — Flagstaff, Arizona, United States
TOI Clinical Research — Cerritos, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Long Beach Memorial Medical Center — Long Beach, California, United States
University of Southern California — Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
PET/CT Imaging of San Jose — San Jose, California, United States
Providence Saint John's Health Center — Santa Monica, California, United States
Valley Breast Care — Van Nuys, California, United States
Tampa General Hospital Cancer Institute — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
MD Clinics — Shreveport, Louisiana, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
The New York Presbyterian Hospital-Columbia University Medical Center — New York, New York, United States
WakeMed — Cary, North Carolina, United States
Duke University — Durham, North Carolina, United States
Kettering Health Cancer Center — Kettering, Ohio, United States
St. Luke's University Health Network — Allentown, Pennsylvania, United States
University of Pennsylvania / Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Baylor Research Institute d/b/a Baylor Scott & White Research Institute — Dallas, Texas, United States
University of Virginia — Charlottesville, Virginia, United States
Blue Ridge Cancer Care — Roanoke, Virginia, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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