FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Computed Tomography+Fludeoxyglucose F-18+Positron Emission Tomography
Status: Active_not_recruiting
Location: See all (104) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arizona
Cancer Center at Saint Joseph's
Phoenix
California
Los Angeles General Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
University of California Davis Comprehensive Cancer Center
Sacramento
UCSF Medical Center-Mission Bay
San Francisco
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
Delaware
Bayhealth Hospital Kent Campus
Dover
Florida
GenesisCare USA - Aventura FP
Aventura
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Grady Health System
Atlanta
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Saint Alphonsus Cancer Care Center-Nampa
Nampa
Illinois
Northwestern University
Chicago
Carle at The Riverfront
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Carle Physician Group-Effingham
Effingham
Northwestern Medicine Cancer Center Delnor
Geneva
Carle Physician Group-Mattoon/Charleston
Mattoon
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Kentucky
Jewish Hospital
Louisville
Massachusetts
Dana-Farber Cancer Institute
Boston
Maryland
UPMC Western Maryland
Cumberland
Michigan
Wayne State University/Karmanos Cancer Institute
Detroit
Saint John Macomb-Oakland Hospital
Warren
Minnesota
Minnesota Oncology - Burnsville
Burnsville
Mercy Hospital
Coon Rapids
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Abbott-Northwestern Hospital
Minneapolis
United Hospital
Saint Paul
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Missouri
Siteman Cancer Center at Saint Peters Hospital
City Of Saint Peters
Siteman Cancer Center at West County Hospital
Creve Coeur
CoxHealth South Hospital
Springfield
Siteman Cancer Center at Christian Hospital
St Louis
Siteman Cancer Center-South County
St Louis
Washington University School of Medicine
St Louis
Nebraska
Nebraska Medicine-Bellevue
Bellevue
Nebraska Medicine-Village Pointe
Omaha
University of Nebraska Medical Center
Omaha
New Jersey
Cooper Hospital University Medical Center
Camden
Morristown Medical Center
Morristown
Overlook Hospital
Summit
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township
New Mexico
University of New Mexico Cancer Center
Albuquerque
New York
Mount Sinai Hospital
New York
NYP/Weill Cornell Medical Center
New York
Montefiore Medical Center-Einstein Campus
The Bronx
Ohio
Indu and Raj Soin Medical Center
Beavercreek
Ohio State University Comprehensive Cancer Center
Columbus
Kettering Medical Center
Kettering
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Bryn Mawr Hospital
Bryn Mawr
Geisinger Medical Center
Danville
Riddle Memorial Hospital
Media
Paoli Memorial Hospital
Paoli
Fox Chase Cancer Center
Philadelphia
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
Lankenau Medical Center
Wynnewood
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
Gibbs Cancer Center-Gaffney
Gaffney
Gibbs Cancer Center-Pelham
Greer
Spartanburg Medical Center
Spartanburg
MGC Hematology Oncology-Union
Union
Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
University of Texas Health Science Center at San Antonio
San Antonio
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
Washington
FHCC South Lake Union
Seattle
Fred Hutchinson Cancer Research Center
Seattle
University of Washington Medical Center - Montlake
Seattle
Wisconsin
Marshfield Medical Center-EC Cancer Center
Eau Claire
University of Wisconsin Carbone Cancer Center
Madison
Marshfield Medical Center-Marshfield
Marshfield
Marshfield Clinic-Minocqua Center
Minocqua
Marshfield Medical Center-Rice Lake
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
UW Cancer Center at ProHealth Care
Waukesha
Marshfield Medical Center - Weston
Weston
Other Locations
Ireland
Cork University Hospital
Cork
Puerto Rico
Cancer Center-Metro Medical Center Bayamon
Bayamón
Doctors Cancer Center
Manatí
Centro Comprensivo de Cancer de UPR
San Juan
San Juan City Hospital
San Juan
San Juan Community Oncology Group
San Juan
Time Frame
Start Date: 2020-09-15
Completion Date: 2027-08-31
Participants
Target number of participants: 138
Treatments
Experimental: Diagnostic (FDG-PET/CT)
Patients receive FDG 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.
Related Therapeutic Areas
Sponsors
Leads: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov