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

NCT05068726 | Terminated FDA Drug

• 1 other identifier: GE-280-401
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 24

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; PET/CT; Cerianna; FES; Fluoroestradiol F-18

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• SUV

  Time Frame: Baseline, Cerianna PET/CT

• Heterogeneity

  Time Frame: baseline Cerianna PET/CT and within 3 weeks after Cerianna PET/CT

• Confidence

  Time Frame: baseline and within 3 weeks after Cerianna PET/CT

• Change in management

  Timeframe: baseline, 6 months and 18 months after Cerianna PET/CT

Interventions

18F Fluoroestradiol Radiopharmaceutical with PET/CT DRUG

Administration of one dose of 18F FES for PET/CT imaging

Also known as: Cerianna

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• GE Healthcare: lead
• Simbec-Orion Group: collaborator
• Medpace, Inc.: collaborator
• Zionexa: collaborator

Study Sites (24)

Northern Arizona Healthcare

Flagstaff, Arizona, 86001, United States

Location

TOI Clinical Research

Cerritos, California, 90703, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

PET/CT Imaging of San Jose

San Jose, California, 95128, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Valley Breast Care

Van Nuys, California, 91405, United States

Location

Tampa General Hospital Cancer Institute

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MD Clinics

Shreveport, Louisiana, 71104, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, 10032, United States

Location

WakeMed

Cary, North Carolina, 27610, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Kettering Health Cancer Center

Kettering, Ohio, 45429, United States

Location

St. Luke's University Health Network

Allentown, Pennsylvania, 18102, United States

Location

University of Pennsylvania / Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor Research Institute d/b/a Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephanie van de Ven

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: January 5, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (24)