Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT05068726
- Lead Sponsor
- GE Healthcare
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate change in therapeutic management plan assessed by comparing pre/post-Cerianna PET/CT treatment selection (based on comparison of the initial management plan and post-Cerianna PET/CT management plan evaluated within 3 weeks). [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT The percentage of subjects with changes in the therapeutic management plan after Cerianna PET/CT with 95% confidence interval will be estimated by comparison of the initial management plan vs. the post-Cerianna PET/CT management plan evaluated within 3 weeks after Cerianna PET/CT.
- Secondary Outcome Measures
Name Time Method SUV Time Frame: Baseline, Cerianna PET/CT Standard uptake values (SUVs, incl. SUVmax, SUVmean, SUVpeak) of each measurable lesion on Cerianna PET/CT and the inter-lesion variability of Cerianna uptake in individual patients
Change in management Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT Proportion of patients with a change in actual therapeutic management assessed by comparing the therapeutic management plans to the actual therapeutic management at 6 months and 18 months after Cerianna PET/CT
Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients. Time Frame: Baseline, Cerianna PET/CT Cerianna-uptake score per patient, defined as total number of Cerianna-positive lesions divided by all lesions visible on standard-of-care imaging (e.g., CT and/or bone scan, or FDG-PET/CT) and Cerianna PET/CT (lower scores represent greater ER heterogeneity/ER loss; 0 = a negative scan)
Heterogeneity Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT Association between Cerianna heterogeneity scores (inter-lesion SUV variability and Cerianna-uptake score) and patients with/without change in therapeutic management plan
Confidence Time Frame: baseline and within 3 weeks after Cerianna PET/CT Treating physician's confidence level in the therapeutic management plan (measured on a 10-point scale) and the percent change in confidence level before and after Cerianna PET/CT
PFS Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT PFS rate at 6 and 18 months based on heterogeneity in tumor Cerianna uptake. Comparison will be made between patients with and without a change in therapeutic management plan
Trial Locations
- Locations (24)
Northern Arizona Healthcare
🇺🇸Flagstaff, Arizona, United States
TOI Clinical Research
🇺🇸Cerritos, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
WakeMed
🇺🇸Cary, North Carolina, United States
University of Pennsylvania / Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Tampa General Hospital Cancer Institute
🇺🇸Tampa, Florida, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Providence Saint John's Health Center
🇺🇸Santa Monica, California, United States
MD Clinics
🇺🇸Shreveport, Louisiana, United States
The New York Presbyterian Hospital-Columbia University Medical Center
🇺🇸New York, New York, United States
PET/CT Imaging of San Jose
🇺🇸San Jose, California, United States
Duke University
🇺🇸Durham, North Carolina, United States
St. Luke's University Health Network
🇺🇸Allentown, Pennsylvania, United States
Kettering Health Cancer Center
🇺🇸Kettering, Ohio, United States
Baylor Research Institute d/b/a Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Valley Breast Care
🇺🇸Van Nuys, California, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States