Breast Cancer
EA1183 / FEATURE
Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study
STATUS: Closed to Accrual
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.
- Patient must be >= 18 years of age on the day of signing informed consent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance (performance status [PS]) =< 2
- Patient must have radiographically confirmed metastatic breast cancer with histologic confirmation of either metastatic or primary tumor biopsy 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. * NOTE: Confirmation can be documented via a report from a metastatic biopsy; a separate biopsy does not need to be completed. If there is no report from a metastatic biopsy, the pathology report from primary breast cancer diagnosis documenting breast cancer along with estrogen receptor (ER), progesterone receptor (PR) and HER2 status can be utilized
- Patient must have radiologically confirmed bone-dominant (BD) or bone-only (BO) disease confirmed by scans obtained within 60 days prior to registration * BD is 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 imaging ** NOTE: Limited measurable metastases include 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 lytic/blastic bone metastases will be allowed. Sites of radiation to bone lesions prior to enrollment must be recorded * BO is defined as detectable disease confined within the bone (any site, any number of lesions). Diagnosis requires abnormalities identified by imaging (bone scan or CT or PET/CT or magnetic resonance imaging [MRI]) with no other sites of metastases identified and with >= 1 non-irradiated bone metastasis on imaging
- 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
- Patient must have no contraindication to FDG-PET imaging which includes glucose values > 200 mg/dL and severe claustrophobia
- Patient must be newly starting one of the following systemic therapies: * Plan to receive either 1st, 2nd or 3rd 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(examples include CDK 4/6 inhibitors mTOR inhibitors and PARP inhibitors for gBRCA mutation) * Plan to receive chemotherapy or antibody drug conjugates per National Comprehensive Cancer Network (NCCN) or institutional standard * Plan to receive HER2-targeted therapy per ASCO, NCCN, and/or institutional guidelines as indicated for patients with HER2 positive disease * NOTE: The use of bone-stabilizing agents (bisphosphonates or denosumab) is permitted * NOTE: Dose modification of an existing treatment does not qualify as a new therapy
- Patient must not have received colony stimulating growth factor within 14 days prior to completing the T0 FDG-PET/CT scan
- Patient must meet institutional guidelines for renal function for MRI and CT scanning
- Patient must have life expectancy estimated at >= 24 weeks
- Patients who have received greater than 3 lines of cytotoxic chemotherapy for metastatic breast cancer are not eligible
- Patients using an investigational agent or using an investigational device within 3 weeks of T0 FDG PET/CT 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
- Patient must be 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
- Patient must complete the baseline (T0) FDG-PET within 28 days after registration. A FDG-PET/CT completed prior to registration may be used if all imaging parameters have been met and patient is able to start treatment within 21 days after completion of FDG/PET CT * 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 all parameters must be met with the following exemption: ** Pregnancy testing documentation prior to FDG-PET (T0 time point) for patients of childbearing potential will not be required
- Patient 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, patients who are breastfeeding are also excluded from this study. All patients of childbearing potential must have a blood test or urine study must be done within 7 days prior to FDG-PET/CT to rule out pregnancy
Ireland
Cork
Cork University Hospital
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United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu
AZ
Phoenix
Cancer Center at Saint Joseph's
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Email: Research-cancerinstitute@dignityhealth.org
CA
Los Angeles
Los Angeles General Medical Center
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USC / Norris Comprehensive Cancer Center
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Sacramento
University of California Davis Comprehensive Cancer Center
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San Francisco
UCSF Medical Center-Mission Bay
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Email: cancertrials@ucsf.edu
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
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DE
Dover
Bayhealth Hospital Kent Campus
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Email: mary_ella_quillen@bayhealth.org
FL
Aventura
GenesisCare USA - Aventura FP
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Email: Rudi.Ross@usa.genesiscare.com
GA
Atlanta
Emory Saint Joseph's Hospital
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Emory University Hospital Midtown
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Emory University Hospital/Winship Cancer Institute
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Grady Health System
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HI
Aiea
Hawaii Cancer Care - Westridge
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Email: info@hawaiicancercare.com
Pali Momi Medical Center
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Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
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Email: i.webster@hawaiicancercare.com
Hawaii Cancer Care Inc-Liliha
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Kapiolani Medical Center for Women and Children
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Queen's Cancer Cenrer - POB I
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Queen's Cancer Center - Kuakini
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Queen's Medical Center
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Straub Clinic and Hospital
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University of Hawaii Cancer Center
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Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
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Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Cancer Care Center-Nampa
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Email: mccinfo@mtcancer.org
IL
Chicago
Northwestern University
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Email: cancer@northwestern.edu
Danville
Carle at The Riverfront
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Email: Research@Carle.com
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
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Email: Donald.Smith3@nm.org
Decatur
Cancer Care Specialists of Illinois - Decatur
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Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
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Email: morganthaler.jodi@mhsil.com
Effingham
Carle Physician Group-Effingham
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Email: Research@carle.com
Geneva
Northwestern Medicine Cancer Center Delnor
Contact: Site Public Contact
Email: Donald.Smith3@nm.org
Mattoon
Carle Physician Group-Mattoon/Charleston
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Email: Research@carle.com
Urbana
Carle Cancer Center
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Email: Research@carle.com
The Carle Foundation Hospital
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Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
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Email: Donald.Smith3@nm.org
KY
Louisville
Jewish Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
MA
Boston
Dana-Farber Cancer Institute
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MD
Cumberland
UPMC Western Maryland
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MI
Detroit
Wayne State University/Karmanos Cancer Institute
Contact: Site Public Contact
Email: ctoadmin@karmanos.org
Warren
Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org
MN
Burnsville
Minnesota Oncology - Burnsville
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Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
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Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
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Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
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Email: mmcorc@healthpartners.com
Saint Paul
United Hospital
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Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
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Email: mmcorc@healthpartners.com
MO
Creve Coeur
Siteman Cancer Center at West County Hospital
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Email: info@siteman.wustl.edu
Saint Louis
Siteman Cancer Center at Christian Hospital
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Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
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Email: info@siteman.wustl.edu
Washington University School of Medicine
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Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
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Email: info@siteman.wustl.edu
Springfield
CoxHealth South Hospital
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NE
Bellevue
Nebraska Medicine-Bellevue
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Email: unmcrsa@unmc.edu
Omaha
Nebraska Medicine-Village Pointe
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University of Nebraska Medical Center
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Email: unmcrsa@unmc.edu
NJ
Camden
Cooper Hospital University Medical Center
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Morristown
Morristown Medical Center
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Summit
Overlook Hospital
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Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
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NM
Albuquerque
University of New Mexico Cancer Center
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Email: HSC-ClinicalTrialInfo@salud.unm.edu
NY
New York
Mount Sinai Hospital
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Email: CCTO@mssm.edu
NYP/Weill Cornell Medical Center
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OH
Beavercreek
Indu and Raj Soin Medical Center
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Email: clinical.trials@daytonncorp.org
Columbus
Ohio State University Comprehensive Cancer Center
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Email: Jamesline@osumc.edu
Kettering
Kettering Medical Center
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Email: clinical.trials@daytonncorp.org
OK
Oklahoma City
University of Oklahoma Health Sciences Center
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Email: ou-clinical-trials@ouhsc.edu
OR
Portland
Oregon Health and Science University
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Email: trials@ohsu.edu
PA
Bryn Mawr
Bryn Mawr Hospital
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Email: turzoe@mlhs.org
Danville
Geisinger Medical Center
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Email: HemonCCTrials@geisinger.edu
East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
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Email: ecog.rss@jimmy.harvard.edu
Media
Riddle Memorial Hospital
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Email: turzoe@mlhs.org
Paoli
Paoli Memorial Hospital
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Email: turzoe@mlhs.org
Philadelphia
Fox Chase Cancer Center
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Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
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Email: HemonCCTrials@geisinger.edu
Wynnewood
Lankenau Medical Center
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Email: turzoe@mlhs.org
PR
Bayamon
Cancer Center-Metro Medical Center Bayamon
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Manati
Doctors Cancer Center
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San Juan
Centro Comprensivo de Cancer de UPR
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Email: ecog.rss@jimmy.harvard.edu
San Juan City Hospital
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San Juan Community Oncology Group
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RI
Providence
Rhode Island Hospital
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SC
Charleston
Medical University of South Carolina
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Email: hcc-clinical-trials@musc.edu
Gaffney
Gibbs Cancer Center-Gaffney
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Email: kmertz-rivera@gibbscc.org
Greer
Gibbs Cancer Center-Pelham
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Email: kmertz-rivera@gibbscc.org
Spartanburg
Spartanburg Medical Center
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Email: kmertz-rivera@gibbscc.org
Union
MGC Hematology Oncology-Union
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Email: kmertz-rivera@gibbscc.org
TX
Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Email: burton@bcm.edu
San Antonio
University of Texas Health Science Center at San Antonio
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Email: phoresearchoffice@uthscsa.edu
UT
Salt Lake City
Huntsman Cancer Institute/University of Utah
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Email: cancerinfo@hci.utah.edu
WA
Seattle
FHCC South Lake Union
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Fred Hutchinson Cancer Center
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University of Washington Medical Center - Montlake
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WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
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Email: oncology.clinical.trials@marshfieldresearch.org
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
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Marshfield
Marshfield Medical Center-Marshfield
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Email: oncology.clinical.trials@marshfieldresearch.org
Minocqua
Marshfield Clinic-Minocqua Center
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Email: oncology.clinical.trials@marshfieldresearch.org
Rice Lake
Marshfield Medical Center-Rice Lake
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Email: oncology.clinical.trials@marshfieldresearch.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
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Email: oncology.clinical.trials@marshfieldresearch.org
Waukesha
UW Cancer Center at ProHealth Care
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Email: Chanda.miller@phci.org
Weston
Marshfield Medical Center - Weston
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Email: oncology.clinical.trials@marshfieldresearch.org
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. V. Assess the ability of qualitative and quantitative changes in serial circulating tumor deoxyribonucleic acid (ctDNA) measures to predict PFS, time to skeletal related events (tSRE), and overall survival in patients. 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. IV. Determine if early metabolic changes in bone metastases assessed by FDG-PET/CT at 4 weeks after start of systemic therapy predict PFS and tSRE in patients with bone-only (BO) or BD MBC. V. Evaluate the relationship between changes in ctDNA and metabolic response as assessed by FDG-PET/CT and to test the combined. 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. Patients also undergo blood sample collection throughout the study. After completion of study, patients are followed up periodically for up to 3 years after study registration.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.