Breast Cancer

EA1183 / FEATURE



Using FDG-PET / CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study

STATUS: Active


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 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 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 have 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 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

  • 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

United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: tmyrick@uab.edu

CA
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact

USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Sacramento
University of California Davis Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: ACTIVE
Contact: Site Public Contact

DE
Dover
Bayhealth Hospital Kent Campus
Status: ACTIVE
Contact: Site Public Contact
Email: mary_ella_quillen@bayhealth.org

FL
Aventura
GenesisCare USA - Aventura FP
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

GA
Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact

Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Emory University Hospital Midtown
Status: ACTIVE
Contact: Site Public Contact

Grady Health System
Status: ACTIVE
Contact: Site Public Contact

HI
Aiea
Hawaii Cancer Care - Savio
Status: ACTIVE
Contact: Site Public Contact
Email: info@hawaiicancercare.com

Pali Momi Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Status: ACTIVE
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com

Hawaii Cancer Care Inc-Liliha
Status: ACTIVE
Contact: Site Public Contact

Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact

Queen's Cancer Cenrer - POB I
Status: ACTIVE
Contact: Site Public Contact

Queen's Cancer Center - Kuakini
Status: ACTIVE
Contact: Site Public Contact

Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact

Straub Clinic and Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

University of Hawaii Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: ACTIVE
Contact: Site Public Contact

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

IL
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@northwestern.edu

Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

KY
Louisville
Jewish Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

MA
Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

MD
Cumberland
Western Maryland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact

MI
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Warren
Saint John Macomb-Oakland Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: karen.forman@ascension.org

MO
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Louis
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact

NJ
Camden
Cooper Hospital University Medical Center
Status: ACTIVE
Contact: Site Public Contact

NM
Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: LByatt@nmcca.org

NY
New York
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact

OH
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Jamesline@osumc.edu

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Portland
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Email: trials@ohsu.edu

PA
Bryn Mawr
Bryn Mawr Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

Media
Riddle Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

Paoli
Paoli Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Wynnewood
Lankenau Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: turzoe@mlhs.org

RI
Providence
Rhode Island Hospital
Status: ACTIVE
Contact: Site Public Contact

SC
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Gaffney
Gibbs Cancer Center-Gaffney
Status: ACTIVE
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Spartanburg
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

Union
MGC Hematology Oncology-Union
Status: ACTIVE
Contact: Site Public Contact
Email: kmertz-rivera@gibbscc.org

TX
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: burton@bcm.edu

San Antonio
University of Texas Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

UT
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

WI
Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Marshfield
Marshfield Medical Center-Marshfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Waukesha
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
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.

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. Assess the ability of qualitative and quantitative changes in serial circulating tumor deoxyribonucleic acid (ctDNA) measures to predict PFS, tSRE, and overall survival in patients.
V. 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.
VI. Evaluate the relationship between changes in ctDNA and metabolic response as assessed by FDG-PET/CT and to test the combined ability of FDG-PET/CT and ctDNA at 4 and 12 weeks after the start of new systemic therapy to predict PFS and tSRE.

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.

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.


EA1183 / FEATURE Home Page
ECOG-ACRIN Cancer Research Group