Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
Breast Cancer
Unknown Primary
GE-280-401 (primary)
NCI-2022-08763
Summary
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.
Eligibility
- 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
Treatment Sites in Georgia
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