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NCT02364557CompletedPhase 2/3

Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
129 (actual)
First submitted
5 Feb 2015
Start date
24 Dec 2014
Primary completion date
20 Dec 2021
Lead sponsor
NRG Oncology
NCT number
NCT02364557

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 129
  • From 24 Dec 2014 to the primary completion date, 20 Dec 2021
  • 162 sites in 4 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

  • Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)
  • Metastases located within 3 cm of the previously irradiated structures:
    • Spinal cord previously irradiated to \> 40 Gy (delivered in =\< 3 Gy/fraction)
    • Brachial plexus previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction)
    • Small intestine, large intestine, or stomach previously irradiated to \> 45 Gy (delivered in =\< 3 Gy/fraction)
    • Brainstem previously irradiated to \> 50 Gy (delivered in =\< 3 Gy/fraction)
    • Whole lung previously irradiated with prior percent volume receiving greater than or equal to 20 Gy (V20Gy)\> 30% (delivered in =\< 3 Gy/fraction)
    • Primary tumor irradiated with SBRT
    • Metastasis irradiated with SBRT
  • Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible

Other illness

  • Patients with any of the following conditions are NOT eligible for this study.
  • Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration;
  • Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported
  • Exudative, bloody, or cytological proven malignant effusions
  • Severe, active co-morbidity defined as follows:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

Lab values

  • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a cluster of differentiation 4 (CD4) count \>= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

Other

  • Metastases with indistinct borders making targeting not feasible
    • Note: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
  • Brain metastases

Who the study is looking for

  • A patient cannot be considered eligible for this study unless all of the following conditions are met.
  • Pathologically confirmed metastatic breast cancer
  • Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis;
    • Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification
  • Number of allowable metastases:
    • =\< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:
    • Peripheral lung
    • Osseous (bone)
    • Spine
    • Central lung
    • Abdominal-pelvic metastases (lymph node/adrenal gland)
    • Liver
    • Mediastinal/cervical lymph node
  • All known disease amenable to metastasis-directed therapy with either SBRT or resection
    • Note: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
    • Note: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
    • Note: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
  • Maximum diameter of individual metastasis in any dimension =\< 5 cm
  • There are no restrictions on distance between the metastases
  • Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy \[surgery or SBRT\] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)
  • The primary tumor site must be controlled prior to registration
    • For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration
    • The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration
    • The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference
  • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 60 days prior to registration
    • Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration
  • Zubrod performance status =\< 2 within 60 days prior to registration
  • Blood cell count (CBC)/differential obtained within 60 days prior to registration on study
  • Absolute neutrophil count (ANC) \>= 500 cells/mm\^3
  • Platelets \>= 50,000 cells/mm\^3
  • Hemoglobin \>= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
  • For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

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

Full criteria on ClinicalTrials.gov

Sites (162)

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

SiteCityCountrySite status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
London Regional Cancer Program
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LondonCanadaUnknown status
The Research Institute of the McGill University Health Centre (MUHC)
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MontrealCanadaUnknown status
CHUM - Centre Hospitalier de l'Universite de Montreal
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MontrealCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Ottawa Hospital and Cancer Center-General Campus
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OttawaCanadaUnknown status
Yonsei University Health System, Severance Hospital
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SeoulSouth KoreaUnknown status
King Faisal Specialist Hospital and Research Centre
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RiyadhSaudi ArabiaUnknown status
Cleveland Clinic Akron General
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AkronUnited StatesUnknown status
New Mexico Oncology Hematology Consultants
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AlbuquerqueUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Lovelace Medical Center-Saint Joseph Square
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AlbuquerqueUnited StatesUnknown status
Lovelace Radiation Oncology
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AlbuquerqueUnited StatesUnknown status
Ascension Saint Vincent Anderson
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AndersonUnited StatesUnknown status
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesUnknown status
Emory University Hospital Midtown
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AtlantaUnited StatesUnknown status
Piedmont Hospital
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AtlantaUnited StatesUnknown status
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
Emory Saint Joseph's Hospital
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AtlantaUnited StatesUnknown status
UCHealth University of Colorado Hospital
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AuroraUnited StatesUnknown status
Texas Oncology-Austin Midtown
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AustinUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesUnknown status
Greater Baltimore Medical Center
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BaltimoreUnited StatesUnknown status
MaineHealth Coastal Cancer Treatment Center
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BathUnited StatesUnknown status
UM Upper Chesapeake Medical Center
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Bel AirUnited StatesUnknown status
Alta Bates Summit Medical Center-Herrick Campus
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BerkeleyUnited StatesUnknown status
MaineHealth Maine Medical Center - Biddeford
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BiddefordUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesUnknown status
Sanford Bismarck Medical Center
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BismarckUnited StatesUnknown status
Henry Ford Cancer Institute-Downriver
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BrownstownUnited StatesUnknown status
Lahey Hospital and Medical Center
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BurlingtonUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
UNC Health Cancer Care Cary
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CaryUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Rush MD Anderson Cancer Center
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ChicagoUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Michigan Healthcare Professionals Clarkston
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ClarkstonUnited StatesUnknown status
Case Western Reserve University
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ClevelandUnited StatesUnknown status
Henry Ford Macomb Hospital-Clinton Township
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Clinton TownshipUnited StatesUnknown status
Penrose-Saint Francis Healthcare
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Colorado SpringsUnited StatesUnknown status
UCHealth Memorial Hospital Central
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Colorado SpringsUnited StatesUnknown status
Central Maryland Radiation Oncology in Howard County
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ColumbiaUnited StatesUnknown status
John B Amos Cancer Center
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ColumbusUnited 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
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Wentworth-Douglass Hospital
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DoverUnited StatesUnknown status
Saint Luke's Hospital of Duluth
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DuluthUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Inova Fairfax Hospital
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Falls ChurchUnited StatesUnknown status
Michigan Healthcare Professionals Farmington
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Farmington HillsUnited StatesUnknown status
Poudre Valley Hospital
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Fort CollinsUnited StatesUnknown status
Parkview Hospital Randallia
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Fort WayneUnited StatesUnknown status
Parkview Regional Medical Center
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Fort WayneUnited StatesUnknown status
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesUnknown status
UNC Health Cancer Care Garner
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GarnerUnited StatesUnknown status
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesUnknown status
CTCA at Western Regional Medical Center
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GoodyearUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Saint Vincent Hospital Cancer Center at Saint Mary's
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Green BayUnited StatesUnknown status
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesUnknown status
Self Regional Healthcare
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GreenwoodUnited StatesUnknown status
Gibbs Cancer Center-Pelham
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GreerUnited StatesUnknown status
Legacy Mount Hood Medical Center
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GreshamUnited StatesUnknown status
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
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HarrisburgUnited StatesUnknown status
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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HollywoodUnited StatesUnknown status
The Cancer Center of Hawaii-Liliha
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Edwards Comprehensive Cancer Center
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HuntingtonUnited StatesUnknown status
Mayo Clinic in Florida
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JacksonvilleUnited StatesUnknown status
West Michigan Cancer Center
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KalamazooUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Gundersen Lutheran Medical Center
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La CrosseUnited StatesUnknown status
UC San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesUnknown status
Los Angeles General Medical Center
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Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Banner North Colorado Medical Center - Loveland Campus
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LovelandUnited StatesUnknown status
Lowell General Hospital
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LowellUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Miami Cancer Institute
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MiamiUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Virtua Memorial
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Mount HollyUnited StatesUnknown status
IU Health Ball Memorial Hospital
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MuncieUnited StatesUnknown status
Helen F Graham Cancer Center
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NewarkUnited StatesUnknown status
CTCA at Southeastern Regional Medical Center
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NewnanUnited StatesUnknown status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesUnknown status
Ogden Regional Medical Center
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OgdenUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
Owensboro Health Mitchell Memorial Cancer Center
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OwensboroUnited StatesUnknown status
Memorial Hospital West
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Pembroke PinesUnited StatesUnknown status
Arizona Center for Cancer Care-Peoria
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PeoriaUnited StatesUnknown status
Methodist Medical Center of Illinois
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PeoriaUnited StatesUnknown status
University of Pennsylvania/Abramson Cancer Center
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PhiladelphiaUnited StatesUnknown status
UPMC-Shadyside Hospital
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PittsburghUnited StatesUnknown status
Allegheny General Hospital
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PittsburghUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesUnknown status
MaineHealth Maine Medical Center - Portland
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PortlandUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Legacy Good Samaritan Hospital and Medical Center
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PortlandUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
UNC Health Cancer Care Wakefield
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RaleighUnited StatesUnknown status
Rex Hematology Oncology Associates-Blue Ridge
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RaleighUnited StatesUnknown status
UNC Health Cancer Care Raleigh
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RaleighUnited StatesUnknown status
Renown Regional Medical Center
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RenoUnited StatesUnknown status
Bon Secours Saint Mary's Hospital
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RichmondUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
The Permanente Medical Group-Roseville Radiation Oncology
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RosevilleUnited StatesUnknown status
Corewell Health William Beaumont University Hospital
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Royal OakUnited StatesUnknown status
Sutter Medical Center Sacramento
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SacramentoUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
Naval Medical Center -San Diego
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San DiegoUnited StatesUnknown status
MaineHealth Cancer Care and IV Therapy - Sanford
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SanfordUnited StatesUnknown status
MaineHealth Cancer Care Center of York County
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SanfordUnited StatesUnknown status
Christus Saint Vincent Regional Cancer Center
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Santa FeUnited StatesUnknown status
Guthrie Medical Group PC-Robert Packer Hospital
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SayreUnited StatesUnknown status
MaineHealth Maine Medical Center- Scarborough
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ScarboroughUnited StatesUnknown status
Memorial Hospital of South Bend
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South BendUnited StatesUnknown status
Kaiser Permanente Cancer Treatment Center
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South San FranciscoUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Mercy Hospital South
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St LouisUnited StatesUnknown status
Missouri Baptist Medical Center
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St LouisUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Saint Joseph's Medical Center
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StocktonUnited StatesUnknown status
Novant Cancer Institute Radiation Oncology - Supply
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SupplyUnited StatesUnknown status
Southwest Illinois Health Services LLP
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SwanseaUnited StatesUnknown status
ProMedica Flower Hospital
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SylvaniaUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
Lewis Hall Singletary Oncology Center
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ThomasvilleUnited StatesUnknown status
Community Medical Center
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Toms RiverUnited StatesUnknown status
Michigan Healthcare Professionals Troy
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TroyUnited StatesUnknown status
Gene Upshaw Memorial Tahoe Forest Cancer Center
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TruckeeUnited StatesUnknown status
Banner University Medical Center - Tucson
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TucsonUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
Legacy Salmon Creek Hospital
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VancouverUnited StatesUnknown status
Virtua Voorhees
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Voorhees TownshipUnited StatesUnknown status
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesUnknown status
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesUnknown status
Henry Ford West Bloomfield Hospital
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West BloomfieldUnited StatesUnknown status
Reading Hospital
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West ReadingUnited StatesUnknown status
Dickstein Cancer Treatment Center
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White PlainsUnited StatesUnknown status
Ascension Via Christi Hospitals Wichita
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WichitaUnited StatesUnknown status
Novant Health New Hanover Regional Medical Center
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WilmingtonUnited StatesUnknown status
Novant Health Cancer Institute Radiation Oncology - Wilmington
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WilmingtonUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status
Midwestern Regional Medical Center
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ZionUnited StatesUnknown status

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