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NCT04316117Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
138 (actual)
First submitted
18 Mar 2020
Start date
15 Sept 2020
Primary completion date
31 Aug 2027
Lead sponsor
ECOG-ACRIN Cancer Research Group
NCT number
NCT04316117

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 138
  • From 15 Sept 2020 to the primary completion date, 31 Aug 2027
  • 104 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (104)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cork University Hospital
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CorkIrelandUnknown status
Cancer Center-Metro Medical Center Bayamon
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BayamónPuerto RicoUnknown status
Doctors Cancer Center
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ManatiPuerto RicoUnknown status
Centro Comprensivo de Cancer de UPR
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San JuanPuerto RicoUnknown status
San Juan City Hospital
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San JuanPuerto RicoUnknown status
San Juan Community Oncology Group
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San JuanPuerto RicoUnknown status
Hawaii Cancer Care - Westridge
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‘AieaUnited StatesUnknown status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Emory Saint Joseph's Hospital
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AtlantaUnited StatesUnknown status
Emory University Hospital Midtown
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AtlantaUnited StatesUnknown status
Grady Health System
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AtlantaUnited StatesUnknown status
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
GenesisCare USA - Aventura FP
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AventuraUnited StatesUnknown status
Indu and Raj Soin Medical Center
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BeavercreekUnited StatesUnknown status
Nebraska Medicine-Bellevue
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BellevueUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Bryn Mawr Hospital
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Bryn MawrUnited StatesUnknown status
Minnesota Oncology - Burnsville
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BurnsvilleUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Caldwell
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CaldwellUnited StatesUnknown status
Cooper Hospital University Medical Center
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CamdenUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Siteman Cancer Center at Saint Peters Hospital
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City of Saint PetersUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesUnknown status
UPMC Western Maryland
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CumberlandUnited StatesUnknown status
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Bayhealth Hospital Kent Campus
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DoverUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
Gibbs Cancer Center-Gaffney
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GaffneyUnited StatesUnknown status
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesUnknown status
Gibbs Cancer Center-Pelham
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GreerUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Queen's Cancer Cenrer - POB I
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HonoluluUnited StatesUnknown status
Queen's Cancer Center - Kuakini
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
University of Hawaii Cancer Center
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc-Liliha
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HonoluluUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Wilcox Memorial Hospital and Kauai Medical Clinic
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LihueUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Los Angeles General Medical Center
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Los AngelesUnited StatesUnknown status
Jewish Hospital
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LouisvilleUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesUnknown status
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
Riddle Memorial Hospital
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MediaUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Marshfield Clinic-Minocqua Center
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MinocquaUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
NYP/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Nebraska Medicine-Village Pointe
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OmahaUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Paoli Memorial Hospital
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PaoliUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
Cancer Center at Saint Joseph's
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PhoenixUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
FHCC South Lake Union
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SeattleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
CoxHealth South Hospital
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SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Siteman Cancer Center-South County
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St LouisUnited StatesUnknown status
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Overlook Hospital
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SummitUnited StatesUnknown status
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesUnknown status
Gene Upshaw Memorial Tahoe Forest Cancer Center
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TruckeeUnited StatesUnknown status
MGC Hematology Oncology-Union
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UnionUnited StatesUnknown status
The Carle Foundation Hospital
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UrbanaUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
MD Anderson Cancer Center at Cooper-Voorhees
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Voorhees TownshipUnited StatesUnknown status
Saint John Macomb-Oakland Hospital
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WarrenUnited StatesUnknown status
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesUnknown status
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesUnknown status
Minnesota Oncology Hematology PA-Woodbury
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WoodburyUnited StatesUnknown status
Lankenau Medical Center
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WynnewoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.