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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04316117
Other study ID # EA1183
Secondary ID NCI-2020-00210EA
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 15, 2020
Est. completion date August 31, 2027

Study information

Verified date April 2024
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.


Description:

PRIMARY OBJECTIVE: I. Evaluate the performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria (modified PET Response Criteria in Solid Tumors [PERCIST] complete, partial and stable metabolic disease versus progressive metabolic disease) as a binary predictor of progression-free survival (PFS) in patients with bone-dominant (BD) metastatic breast cancer (MBC) treated with systemic therapy. SECONDARY OBJECTIVES: I. Evaluate the ability of FDG-PET/CT modified PERCIST criteria (complete versus [vs] partial vs stable vs metabolic progression) to independently predict PFS in patients with BD MBC. II. Evaluate the ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable versus progressive metabolic disease) to predict time to skeletal related events (SRE) and overall survival (OS) in patients with BD MBC. III. Evaluate the ability of FDG-PET/CT metrics (percent change in peak standardized uptake value corrected for lean body mass (SULpeak), maximum standardized uptake value corrected for body weight (SUVmax) as continuous variables in index or up to 5 lesions) to predict PFS, time to SRE and OS in patients with BD MBC. IV. Assess the utility of FDG-PET/CT to identify disease progression by identification of new lesions not identified by standard CT and bone scan. EXPLORATORY OBJECTIVES: I. Define criteria for selection of FDG-avid bone lesions for analysis based on thresholds for SULpeak or SUVmax. II. In collaboration with National Cancer Institute (NCI) Quantitative Imaging Network (QIN), explore alternative methods for measuring metabolic response with FDG-PET/CT (e.g., total lesion glycolysis, quantitative total bone imaging, MD Anderson bone criteria, and radiomics) to predict clinical endpoints in patients with BD MBC. III. Evaluate automated image analysis of FDG-PET/CT by AutoPERCIST. OUTLINE: Patients receive FDG intravenously (IV) and undergo PET/CT scan over 15-30 minutes at baseline (within 21 days before start of standard systemic treatment) and at 12 weeks after start of standard systemic treatment in the absence of unacceptable toxicity. After completion of study, patients are followed up periodically for up to 3 years after study registration.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 138
Est. completion date August 31, 2027
Est. primary completion date August 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance (performance status [PS]) =< 2 - Patients with histologically confirmed metastatic breast cancer by local assessment that is hormone receptor positive by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and with known HER2 status - Patients must have radiologically confirmed bone-dominant (BD) or bone-only (BO) disease - BD defined as disease involving bone with or without limited measurable metastases by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, with >= 1 non-irradiated bone metastasis on bone scintigraphy - NOTE: Limited measurable metastases includes lymph nodes and the soft tissue components of lytic or mixed lytic/blastic bone metastases. Any number of lymph nodes < 3 cm and up to 2 lymph nodes > 3 cm will be allowed. Up to 5 measurable soft tissue components of lytic or mixed mytic/blastic bone metastases will be allowed - BO defined as detectable disease confined within the bone (any site, any number of lesions). Diagnosis requires abnormalities identified by imaging (bone scan, CT +/- PET +/- magnetic resonance imaging [MRI]) with no other sites of metastases identified and with >= 1 non-irradiated bone metastasis on bone scintigraphy - Patients must have no contraindication to FDG-PET imaging - Patients must have one of the following systemic therapies: - Plan to receive either 1st or 2nd line endocrine therapy for metastatic breast cancer. Endocrine therapy may include selective estrogen receptor modulators (SERMs), aromatase inhibitors, and/or fulvestrant that may be combined with Food and Drug Administration (FDA)-approved biologic agents (palbociclib, ribociclib, abemaciclib, everolimus, alpelisib) - Chemotherapy per National Comprehensive Cancer Network (NCCN) or institutional standard. Use of colony stimulating growth factor must be suspended for >= 14 days prior to FDG-PET/CT scans at baseline and 12-weeks - Plan to receive HER2-targeted therapy per ASCO, NCCN, and/or institutional guidelines as indicated for patients with HER2 positive disease. When HER2-targeted therapy is used with chemotherapy, use of colony stimulating growth factors is NOT expected or should be suspended for a minimum of 2 weeks, but preferably for at least 3 weeks prior to the required FDG-PET/CT scan time points - The use of bone-stabilizing agents (bisphosphonates or denosumab) is permitted - Patient must meet institutional guidelines for renal function for MRI and CT scanning - Patient's life expectancy must be estimated at >= 24 weeks - The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined PET/CT scanner qualification procedures and received ECOG-ACRIN PET/CT scanner approval - Patients must complete the baseline (T0) FDG-PET within 28 days prior to registration or within 28 days after registration - For patients completing the baseline (T0) FDG-PET AFTER registration all parameters must be met - For patients who completed the baseline (T0) FDG-PET prior to registration the following tests are exempt: - Pregnancy testing documentation prior to FDG-PET (T0 time point) Exclusion Criteria: - Patients with RECIST 1.1 measurable lesions in viscera, active central nervous system (CNS), leptomeningeal carcinomatous or pleural or peritoneal disease will not be eligible. Patients with prior CNS metastases treated with radiation or resection and without evidence of clinical or radiographic progression within 28 days of registration are eligible - Patients who have received greater than 3 lines of cytotoxic chemotherapy for metastatic breast cancer are not eligible - Patients currently participating in or have participated in a study of an investigational agent or using an investigational device within 3 weeks of study registration are not eligible - Patients with known additional malignancy that is progressing or requires active treatment are not eligible. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy - Women must not be pregnant because FDG is a radiopharmaceutical with the potential for teratogenic effects and PET/CT involves additional radiation exposure. In addition, because of radiation exposure to a nursing infant from FDG, women who are breastfeeding are also excluded from this study. All females of childbearing potential must have a blood test or urine study within 7 days prior to FDG-PET/CT to rule out pregnancy. Patients are excluded from this if baseline FDG-PET/CT scan met study parameters and was completed within 28 days of study registration

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Computed Tomography
Undergo PET/CT
Other:
Fludeoxyglucose F-18
Given IV
Procedure:
Positron Emission Tomography
Undergo PET/CT

Locations

Country Name City State
Ireland Cork University Hospital Cork
Puerto Rico Cancer Center-Metro Medical Center Bayamon Bayamon
Puerto Rico Doctors Cancer Center Manati
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Grady Health System Atlanta Georgia
United States GenesisCare USA - Aventura FP Aventura Florida
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Nebraska Medicine-Bellevue Bellevue Nebraska
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern University Chicago Illinois
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States UPMC Western Maryland Cumberland Maryland
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Bayhealth Hospital Kent Campus Dover Delaware
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Carle Physician Group-Effingham Effingham Illinois
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Kettering Medical Center Kettering Ohio
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Riddle Memorial Hospital Media Pennsylvania
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Morristown Medical Center Morristown New Jersey
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Mount Sinai Hospital New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UCSF Medical Center-Mission Bay San Francisco California
United States FHCC South Lake Union Seattle Washington
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Overlook Hospital Summit New Jersey
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Ireland,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Defining of criteria for selection of FDG-avid bone lesions for analysis based on thresholds for SULpeak or SUVmax Will vary the threshold for inclusion in the PERCIST criteria to get optimum performance. To reduce the over-optimism, will apply the statistical technique of 5-fold cross-validation in the threshold discovery and subsequent performance assessment. Up to 3 years after study registration
Other Exploration of alternative methods for measuring metabolic response with FDG-PET/CT to predict clinical endpoints in patients with BD MBC Will collaborate with National Cancer Institute Quantitative Imaging Network to explore alternative methods for measuring metabolic response with FDG-PET/CT scans. Will then implement Kaplan Meier survival curve (and log-rank test) or multivariable Cox proportional hazard model in the analyses of associations with PFS, time to SRE, or OS. Up to 3 years after study registration
Other Automated image analysis of FDG-PET/CT Will evaluate automated image analysis of FDG-PET/CT by AutoPERCIST. Up to 3 years after study registration
Primary Performance of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) response criteria as a binary predictor of progression-free survival (PFS) Will evaluate the performance of FDG-PET/CT response criteria (modified PET Response Criteria in Solid Tumors complete, partial and stable metabolic disease versus progressive metabolic disease) as a binary predictor of PFS in patients with bone-dominant (BD) metastatic breast cancer (MBC) treated with systemic therapy. Up to 3 years after study registration
Secondary Ability of FDG-PET/CT modified PERCIST criteria (complete versus [vs] partial vs stable vs metabolic progression) to independently predict PFS in patients with BD MBC Will keep the multiple categories of FDG-PET/CT modified PERCIST criteria and test the PFS differences across them using the Kaplan-Meier survival curve and the corresponding log-rank test. The multivariable Cox proportional hazard model will be also fitted with the adjustment of the same set of confounders (e.g., age, line of therapy - early line treatment versus late line treatment, type of therapy - endocrine therapy versus chemotherapy). Since the categories of FDG-PET/CT modified PERCIST criteria are ordered, will also apply the method of C-statistics to evaluate the performance after quantifying the criteria (i.e., 1-complete response, 2-partial response, 3-stable, 4-metabolic progression). Up to 3 years after study registration
Secondary Ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable vs progressive metabolic disease) to predict time to skeletal related events (SRE) in patients with BD MBC Will keep the multiple categories of FDG-PET/CT modified PERCIST criteria and test the time to SRE differences across them using the Kaplan-Meier survival curve and the corresponding log-rank test. The multivariable Cox proportional hazard model will be also fitted with the adjustment of the same set of confounders (e.g., age, line of therapy - early line treatment versus late line treatment, type of therapy - endocrine therapy versus chemotherapy). Since the categories of FDG-PET/CT modified PERCIST criteria are ordered, will also apply the method of C-statistics to evaluate the performance after quantifying the criteria (i.e., 1-complete response, 2-partial response, 3-stable, 4-metabolic progression). Up to 3 years after study registration
Secondary Ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable vs progressive metabolic disease) to predict overall survival (OS) in patients with BD MBC Will keep the multiple categories of FDG-PET/CT modified PERCIST criteria and test the OS differences across them using the Kaplan-Meier survival curve and the corresponding log-rank test. The multivariable Cox proportional hazard model will be also fitted with the adjustment of the same set of confounders (e.g., age, line of therapy - early line treatment versus late line treatment, type of therapy - endocrine therapy versus chemotherapy). Since the categories of FDG-PET/CT modified PERCIST criteria are ordered, will also apply the method of C-statistics to evaluate the performance after quantifying the criteria (i.e., 1-complete response, 2-partial response, 3-stable, 4-metabolic progression). Up to 3 years after study registration
Secondary Ability of FDG-PET/CT metrics to predict PFS in patients with BD MBC For each participant, will collect up to 5 lesions from FDG-PET/CT scans and calculate the percent change in peak standardized uptake value corrected for lean body mass (SULpeak), maximum standardized uptake value corrected for body weight (SUVmax) from T0 to T1 scans. Multivariable Cox proportional hazard models will be used to model the ability of these changes to predict PFS. The analysis will first be conducted on the index lesion (i.e., associating the change of SUVpeak or SUVmax for the index lesion with outcomes), and then be applied to the average change of up to 5 lesions (i.e., associating the average change of SUVpeak or SUVmax from all detected lesions with outcomes). The C-statistics will be used to measure the performance. Up to 3 years after study registration
Secondary Ability of FDG-PET/CT metrics to predict time to SRE in patients with BD MBC For each participant, will collect up to 5 lesions from FDG-PET/CT scans and calculate the percent change in SULpeak, SUVmax from T0 to T1 scans. Multivariable Cox proportional hazard models will be used to model the ability of these changes to predict time to SRE. The analysis will first be conducted on the index lesion (i.e., associating the change of SUVpeak or SUVmax for the index lesion with outcomes), and then be applied to the average change of up to 5 lesions (i.e., associating the average change of SUVpeak or SUVmax from all detected lesions with outcomes). The C-statistics will be used to measure the performance. Up to 3 years after study registration
Secondary Ability of FDG-PET/CT metrics to predict OS in patients with BD MBC For each participant, will collect up to 5 lesions from FDG-PET/CT scans and calculate the percent change in SULpeak, SUVmax from T0 to T1 scans. Multivariable Cox proportional hazard models will be used to model the ability of these changes to predict OS. The analysis will first be conducted on the index lesion (i.e., associating the change of SUVpeak or SUVmax for the index lesion with outcomes), and then be applied to the average change of up to 5 lesions (i.e., associating the average change of SUVpeak or SUVmax from all detected lesions with outcomes). The C-statistics will be used to measure the performance. Up to 3 years after study registration
Secondary Utility of FDG-PET/CT to identify disease progression by identification of new lesions not identified by standard CT and bone scan For the cases where progression is documented in the study, will record and tabulate the number of new lesions uniquely identified by the 12-week FDG-PET/CT research scan. Up to 3 years after study registration
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