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

Metastatic Breast Cancer Clinical Trial

Official title:

Clinical Utility of Fluoroestradiol F18 PET/CT in Metastatic Breast Cancer Patients With ER-Positive and HER2-Negative Primary Lesions After Progression on First Line Hormonal Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05068726
• Other study ID #: GE-280-401
• Status: Terminated
• Start date: January 5, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2024
• Source: Zionexa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Administration of one dose of 18F FES for PET/CT imaging

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Zionexa	GE Healthcare, Medpace, Inc., Simbec-Orion Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	[Time Frame: Baseline and within 3 weeks after Cerianna PET/CT
Secondary	Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients.	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)	Time Frame: Baseline, Cerianna PET/CT
Secondary	SUV	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	Time Frame: Baseline, Cerianna PET/CT
Secondary	Heterogeneity	Association between Cerianna heterogeneity scores (inter-lesion SUV variability and Cerianna-uptake score) and patients with/without change in therapeutic management plan	Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT
Secondary	Confidence	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	Time Frame: baseline and within 3 weeks after Cerianna PET/CT
Secondary	Change in management	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	Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
Secondary	PFS	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	Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT