Clinical trial NCT05068726: Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
PET/CT
Cerianna
FES
Fluoroestradiol F-18
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Simbec-Orion Group
name: Medpace, Inc.
name: Zionexa
First posted: 2021-10-06
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic Breast Cancer Patients with ER-Positive and HER2-Negative Primary Lesions after Progression on First Line Hormonal Therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT
Secondary outcomes:
measure: Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients.
timeFrame: Time Frame: Baseline, Cerianna PET/CT
measure: SUV
timeFrame: Time Frame: Baseline, Cerianna PET/CT
measure: Heterogeneity
timeFrame: Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT
measure: Confidence
timeFrame: Time Frame: baseline and within 3 weeks after Cerianna PET/CT
measure: Change in management
timeFrame: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
measure: PFS
timeFrame: Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona Healthcare
state: Arizona
city: Cerritos
country: United States
facility: TOI Clinical Research
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: San Jose
country: United States
facility: PET/CT Imaging of San Jose
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Health Center
state: California
city: Van Nuys
country: United States
facility: Valley Breast Care
state: California
city: Tampa
country: United States
facility: Tampa General Hospital Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Shreveport
country: United States
facility: MD Clinics
state: Louisiana
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: The New York Presbyterian Hospital-Columbia University Medical Center
state: New York
city: Cary
country: United States
facility: WakeMed
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Kettering
country: United States
facility: Kettering Health Cancer Center
state: Ohio
city: Allentown
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania / Perelman Center for Advanced Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute d/b/a Baylor Scott & White Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: GE Healthcare
name: Stephanie van de Ven
role: STUDY_DIRECTOR
References: