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Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer

RecruitingPhase 3

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines

  * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible
* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer

  * NOTE: Participants with inflammatory breast cancer are eligible
  * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node
* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines
* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer
* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions

  * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued
* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status

  * Submitting tissue for on-study MammaPrint testing:

    * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment

      * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR
  * Submitting prior known MammaPrint Index Score:

    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy

      * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network
      * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study
      * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment
* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy
* STEP 1: REGISTRATION (SCREENING): Participants must be \>= 18 years old at the time of registration
* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \> 30 kg
* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2
* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration
* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result

  * For participants submitting tissue for on-study MammaPrint testing:

    * Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR
  * Submitting commercial MammaPrint Index Score:

    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy

      * NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization
* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed
* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2
* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Platelets \>= 100 x 10\^3/uL (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to Step 2: Randomization)
* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \>= 50 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization
* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated
* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated
* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study
* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

About the study

This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.

What is being tested

Sponsor: National Cancer Institute (NCI) · Participants: 3,680 · Started: Nov 27, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06058377

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Cancer Center, Birmingham
AlaskaKatmai Oncology Group, Anchorage
ArizonaBanner University Medical Center - Tucson, Tucson
University of Arizona Cancer Center-North Campus, Tucson
University of Arizona Cancer Center-Orange Grove Campus, Tucson
ArkansasMercy Hospital Fort Smith, Fort Smith
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro
University of Arkansas for Medical Sciences, Little Rock
CaliforniaSutter Auburn Faith Hospital, Auburn
AIS Cancer Center at San Joaquin Community Hospital, Bakersfield
Alta Bates Summit Medical Center-Herrick Campus, Berkeley
Tower Cancer Research Foundation, Beverly Hills
City of Hope Comprehensive Cancer Center, Duarte
Palo Alto Medical Foundation-Fremont, Fremont
City of Hope at Irvine Lennar, Irvine
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
City of Hope Antelope Valley, Lancaster
Loma Linda University Medical Center, Loma Linda
City of Hope at Long Beach Elm, Long Beach
Cedars-Sinai Medical Center, Los Angeles
The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles
Memorial Medical Center, Modesto
City of Hope Newport Beach, Newport Beach
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange
Desert Regional Medical Center, Palm Springs
Palo Alto Medical Foundation Health Care, Palo Alto
Huntington Memorial Hospital, Pasadena
Sutter Roseville Medical Center, Roseville
SWOG, Sacramento
Sutter Medical Center Sacramento, Sacramento
California Pacific Medical Center-Pacific Campus, San Francisco
Mills Health Center, San Mateo
Palo Alto Medical Foundation-Santa Cruz, Santa Cruz
Saint John's Cancer Institute, Santa Monica
Providence Medical Foundation - Santa Rosa, Santa Rosa
Providence Santa Rosa Memorial Hospital, Santa Rosa
Sutter Pacific Medical Foundation, Santa Rosa
City of Hope South Pasadena, South Pasadena
Palo Alto Medical Foundation-Sunnyvale, Sunnyvale
Cedars-Sinai Cancer - Tarzana, Tarzana
City of Hope South Bay, Torrance
Torrance Memorial Physician Network - Cancer Care, Torrance
City of Hope Upland, Upland
Sutter Solano Medical Center/Cancer Center, Vallejo
UCI Health - Yorba Linda, Yorba Linda
ColoradoUCHealth University of Colorado Hospital, Aurora
UCHealth - Cherry Creek, Denver
Shaw Cancer Center, Edwards
Cancer Care and Hematology-Fort Collins, Fort Collins
Poudre Valley Hospital, Fort Collins
UCHealth Greeley Hospital, Greeley
UCHealth Highlands Ranch Hospital, Highlands Ranch
UCHealth Lone Tree Health Center, Lone Tree
Medical Center of the Rockies, Loveland
ConnecticutSmilow Cancer Hospital-Derby Care Center, Derby
Smilow Cancer Hospital Care Center-Fairfield, Fairfield
Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury
Smilow Cancer Hospital Care Center at Greenwich, Greenwich
Smilow Cancer Hospital Care Center - Guilford, Guilford
Smilow Cancer Hospital Care Center at Saint Francis, Hartford
Yale University, New Haven
Yale-New Haven Hospital North Haven Medical Center, North Haven
Smilow Cancer Hospital Care Center at Long Ridge, Stamford
Smilow Cancer Hospital-Torrington Care Center, Torrington
Smilow Cancer Hospital Care Center-Trumbull, Trumbull
Smilow Cancer Hospital-Waterbury Care Center, Waterbury
Smilow Cancer Hospital Care Center - Waterford, Waterford
DelawareBeebe South Coastal Health Campus, Millville
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
District of ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaMount Sinai Comprehensive Cancer Center at Aventura, Aventura
Schulze Family Foundation Cancer Clinic - Bonita Health Center, Bonita Springs
Morton Plant Hospital, Clearwater
Regional Cancer Center-Lee Memorial Health System, Fort Myers
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood
Mount Sinai Medical Center, Miami Beach
Memorial Hospital West, Pembroke Pines
Mease Countryside Hospital, Safety Harbor
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa
Winter Haven Hospital, Winter Haven
GeorgiaEmory Saint Joseph's Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
Grady Health System, Atlanta
Emory Decatur Hospital, Decatur
Emory Johns Creek Hospital, Johns Creek
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah
Memorial Health University Medical Center, Savannah
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Luke's Cancer Institute - Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Luke's Cancer Institute - Fruitland, Fruitland
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Saint Luke's Cancer Institute - Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisAdvocate Outpatient Center - Aurora, Aurora
Advocate Good Shepherd Hospital, Barrington
Illinois CancerCare-Bloomington, Bloomington
Illinois CancerCare-Canton, Canton
SIH Cancer Institute, Carterville
Illinois CancerCare-Carthage, Carthage
Advocate Illinois Masonic Medical Center, Chicago
Mount Sinai Hospital Medical Center, Chicago
Northwestern University, Chicago
University of Illinois, Chicago
AMG Crystal Lake - Oncology, Crystal Lake
Carle at The Riverfront, Danville
Northwestern Medicine Cancer Center Kishwaukee, DeKalb
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Advocate Good Samaritan Hospital, Downers Grove
Carle Physician Group-Effingham, Effingham
Crossroads Cancer Center, Effingham
Advocate Sherman Hospital, Elgin
Illinois CancerCare-Eureka, Eureka
Illinois CancerCare-Galesburg, Galesburg
Northwestern Medicine Cancer Center Delnor, Geneva
Northwestern Medicine Glenview Outpatient Center, Glenview
Northwestern Medicine Grayslake Outpatient Center, Grayslake
Advocate South Suburban Hospital, Hazel Crest
Illinois CancerCare-Kewanee Clinic, Kewanee
Northwestern Medicine Lake Forest Hospital, Lake Forest
AMG Libertyville - Oncology, Libertyville
Condell Memorial Hospital, Libertyville
Illinois CancerCare-Macomb, Macomb
Carle Physician Group-Mattoon/Charleston, Mattoon
Loyola University Medical Center, Maywood
Trinity Medical Center, Moline
SSM Health Good Samaritan, Mount Vernon
Carle BroMenn Medical Center, Normal
Carle Cancer Institute Normal, Normal
Cancer Care Center of O'Fallon, O'Fallon
Northwestern Medicine Oak Brook, Oak Brook
Advocate Christ Medical Center, Oak Lawn
Northwestern Medicine Orland Park, Orland Park
Illinois CancerCare-Ottawa Clinic, Ottawa
Advocate Lutheran General Hospital, Park Ridge
Illinois CancerCare-Pekin, Pekin
Illinois CancerCare-Peoria, Peoria
Illinois CancerCare-Peru, Peru
Illinois CancerCare-Princeton, Princeton
OSF Saint Anthony Medical Center, Rockford
UW Health Carbone Cancer Center Rockford, Rockford
Memorial Hospital East, Shiloh
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Carle Cancer Center, Urbana
Northwestern Medicine Cancer Center Warrenville, Warrenville
Illinois CancerCare - Washington, Washington
IndianaNorthwest Cancer Center - Crown Point, Crown Point
Northwest Oncology LLC, Dyer
Northwest Cancer Center - Hobart, Hobart
Saint Mary Medical Center, Hobart
Saint Catherine Hospital, Indianapolis
The Community Hospital, Munster
Women's Diagnostic Center - Munster, Munster
Northwest Cancer Center - Valparaiso, Valparaiso
IowaUI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny
Saint Anthony Regional Hospital, Carroll
Mercy Hospital, Cedar Rapids
Oncology Associates at Mercy Medical Center, Cedar Rapids
UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive
Broadlawns Medical Center, Des Moines
Iowa Methodist Medical Center, Des Moines
Mercy Medical Center - Des Moines, Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines
UI Healthcare Mission Cancer and Blood - Fort Dodge, Fort Dodge
UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee
KansasHaysMed, Hays
University of Kansas Cancer Center, Kansas City
Lawrence Memorial Hospital, Lawrence
The University of Kansas Cancer Center - Olathe, Olathe
University of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Indian Creek Campus, Overland Park
Salina Regional Health Center, Salina
University of Kansas Health System Saint Francis Campus, Topeka
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyBaptist Health Corbin, Corbin
CommonSpirit Saint Joseph Medical Center - East Lexington, Lexington
University of Kentucky/Markey Cancer Center, Lexington
LouisianaAbbeville General Hospital, Abbeville
Ochsner LSU Health Monroe Medical Center, Monroe
Touro Infirmary, New Orleans
University Medical Center New Orleans, New Orleans
LSU Health Sciences Center at Shreveport, Shreveport
Ochsner LSU Health - Cancer Treatment Center, Shreveport
MarylandUM Upper Chesapeake Hematology and Oncology - Aberdeen, Aberdeen
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
Mercy Medical Center, Baltimore
Sinai Hospital of Baltimore, Baltimore
University of Maryland/Greenebaum Cancer Center, Baltimore
UM Upper Chesapeake Medical Center, Bel Air
UPMC Western Maryland, Cumberland
FMH James M Stockman Cancer Institute, Frederick
UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie
William E Kahlert Regional Cancer Center/Sinai Hospital, Westminster
MassachusettsBeverly Hospital, Beverly
Tufts Medical Center, Boston
Lahey Clinic, Burlington
Addison Gilbert Hospital, Gloucester
Lahey Clinic Peabody, Peabody
MichiganTrinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
University of Michigan Rogel Cancer Center, Ann Arbor
Bronson Battle Creek, Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Trinity Health Medical Center - Brighton, Brighton
University of Michigan - Brighton Center for Specialty Care, Brighton
Henry Ford Cancer Institute-Downriver, Brownstown
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health Medical Center - Canton, Canton
Chelsea Hospital, Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Hematology Oncology Consultants-Clarkston, Clarkston
Henry Ford Macomb Hospital-Clinton Township, Clinton Township
Corewell Health Dearborn Hospital, Dearborn
Henry Ford Medical Center-Fairlane, Dearborn
Henry Ford Health Saint John Hospital, Detroit
Henry Ford Hospital, Detroit
Wayne State University/Karmanos Cancer Institute, Detroit
Henry Ford River District Hospital, East China Township
OSF Saint Francis Hospital and Medical Group, Escanaba
Corewell Health Farmington Hills Hospital, Farmington Hills
Weisberg Cancer Treatment Center, Farmington Hills
Cancer Hematology Centers - Flint, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Trinity Health Grand Rapids Hospital, Grand Rapids
Henry Ford Saint John Hospital - Van Elslander, Grosse Pointe Woods
Allegiance Health, Jackson
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
Karmanos Cancer Institute at McLaren Greater Lansing, Lansing
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Henry Ford Saint John Hospital - Macomb Medical, Macomb
Trinity Health Muskegon Hospital, Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores
Henry Ford Health Providence Novi Hospital, Novi
Henry Ford Medical Center-Columbus, Novi
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
Corewell Health Reed City Hospital, Reed City
Corewell Health William Beaumont University Hospital, Royal Oak
MyMichigan Medical Center Saginaw, Saginaw
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
Henry Ford Health Providence Southfield Hospital, Southfield
MyMichigan Medical Center Tawas, Tawas City
Munson Medical Center, Traverse City
Corewell Health Beaumont Troy Hospital, Troy
Henry Ford Health Warren Hospital, Warren
Henry Ford Warren Hospital - GLCMS, Warren
Henry Ford West Bloomfield Hospital, West Bloomfield
Henry Ford Wyandotte Hospital, Wyandotte
University of Michigan Health - West, Wyoming
Huron Gastroenterology PC, Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaEssentia Health Saint Joseph's Medical Center, Brainerd
Minnesota Oncology - Burnsville, Burnsville
Minnesota Oncology Hematology PA-Chaska, Chaska
Mercy Hospital, Coon Rapids
Essentia Health - Deer River Clinic, Deer River
Essentia Health Cancer Center, Duluth
Saint Luke's Hospital of Duluth, Duluth
Fairview Southdale Hospital, Edina
Minnesota Oncology - Edina, Edina
Essentia Health Hibbing Clinic, Hibbing
Saint John's Hospital - Healtheast, Maplewood
Abbott-Northwestern Hospital, Minneapolis
Hennepin County Medical Center, Minneapolis
North Memorial Medical Health Center, Robbinsdale
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Essentia Health Sandstone, Sandstone
Saint Francis Regional Medical Center, Shakopee
Lakeview Hospital, Stillwater
Essentia Health Virginia Clinic, Virginia
Ridgeview Medical Center, Waconia
Minnesota Oncology Hematology PA-Woodbury, Woodbury
MississippiBaptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus
Baptist Cancer Center-Grenada, Grenada
Baptist Memorial Hospital and Cancer Center-Union County, New Albany
Baptist Memorial Hospital and Cancer Center-Oxford, Oxford
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven
MissouriMercy Oncology and Hematology - Clayton-Clarkson, Ballwin
Saint Francis Medical Center, Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Parkland Health Center - Farmington, Farmington
University Health Truman Medical Center, Kansas City
University of Kansas Cancer Center - Briarcliff, Kansas City
University of Kansas Cancer Center - North, Kansas City
University of Kansas Cancer Center - Lee's Summit, Lee's Summit
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
CoxHealth South Hospital, Springfield
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
Missouri Baptist Medical Center, St Louis
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Community Medical Center, Missoula
NevadaRenown Regional Medical Center, Reno
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyTrinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus, Elizabeth
Hackettstown Medical Center, Hackettstown
The Cancer Institute of New Jersey Hamilton, Hamilton
Jersey City Medical Center, Jersey City
Monmouth Medical Center Southern Campus, Lakewood
Monmouth Medical Center, Long Branch
Morristown Medical Center, Morristown
Rutgers Cancer Institute of New Jersey, New Brunswick
Newark Beth Israel Medical Center, Newark
Rutgers New Jersey Medical School, Newark
Newton Medical Center, Newton
Chilton Medical Center, Pompton
Robert Wood Johnson University Hospital Somerset, Somerville
Overlook Hospital, Summit
Community Medical Center, Toms River
New YorkNYU Langone Hospital - Brooklyn, Brooklyn
The Cancer Institute at Saint Francis Hospital, East Hills
NYU Langone Hospital - Long Island, Mineola
Northern Westchester Hospital, Mount Kisco
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York
Lenox Hill Hospital, New York
Manhattan Eye Ear and Throat Hospital, New York
Mount Sinai Chelsea, New York
Mount Sinai Hospital, New York
Mount Sinai West, New York
Upstate Cancer Center at Oswego, Oswego
Phelps Memorial Hospital Center, Sleepy Hollow
The Philips Family Cancer Center, Southampton
Staten Island University Hospital, Staten Island
Stony Brook University Medical Center, Stony Brook
SUNY Upstate Medical Center-Community Campus, Syracuse
State University of New York Upstate Medical University, Syracuse
Upstate Cancer Center at Verona, Verona
Good Samaritan University Hospital, West Islip
Dickstein Cancer Treatment Center, White Plains
North CarolinaUNC Health Cancer Care Cary, Cary
UNC Lineberger Comprehensive Cancer Center, Chapel Hill
Southeastern Medical Oncology Center-Clinton, Clinton
UNC Health Cancer Care Garner, Garner
Southeastern Medical Oncology Center-Goldsboro, Goldsboro
University of North Carolina-Hillsborough Campus, Hillsborough
Southeastern Medical Oncology Center-Jacksonville, Jacksonville
UNC Health Cancer Care Raleigh, Raleigh
UNC Health Cancer Care Wakefield, Raleigh
North DakotaEssentia Health Cancer Center-South University Clinic, Fargo
OhioMiami Valley Hospital South, Centerville
MetroHealth Medical Center, Cleveland
Columbus Oncology and Hematology Associates Inc, Columbus
Doctors Hospital, Columbus
Grant Medical Center, Columbus
Ohio State University Comprehensive Cancer Center, Columbus
Riverside Methodist Hospital, Columbus
Miami Valley Hospital, Dayton
Miami Valley Hospital North, Dayton
Premier Blood and Cancer Center, Dayton
Delaware Health Center-Grady Cancer Center, Delaware
Grady Memorial Hospital, Delaware
Columbus Oncology and Hematology Associates, Dublin
Dublin Methodist Hospital, Dublin
Atrium Medical Center-Middletown Regional Hospital, Franklin
Miami Valley Cancer Care and Infusion, Greenville
OhioHealth Mansfield Hospital, Mansfield
OhioHealth Marion General Hospital, Marion
OhioHealth Pickerington Methodist Hospital, Pickerington
ProMedica Flower Hospital, Sylvania
OhioHealth Westerville Medical Campus/Westerville Cancer Center, Westerville
OklahomaMercy Hospital Oklahoma City, Oklahoma City
University of Oklahoma Health Sciences Center, Oklahoma City
OregonSaint Charles Health System, Bend
Legacy Mount Hood Medical Center, Gresham
Saint Alphonsus Cancer Care Center-Ontario, Ontario
Legacy Good Samaritan Hospital and Medical Center, Portland
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
Legacy Meridian Park Hospital, Tualatin
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Saint Luke's Cancer Center - Allentown, Allentown
UPMC-Heritage Valley Health System Beaver, Beaver
Lehigh Valley Hospital - Muhlenberg, Bethlehem
Saint Luke's University Hospital-Bethlehem Campus, Bethlehem
Bryn Mawr Hospital, Bryn Mawr
UPMC Hillman Cancer Center at Butler Health System, Butler
UPMC Hillman Cancer Center - Passavant - Cranberry, Cranberry Township
Geisinger Medical Center, Danville
Geisinger Cancer Center Dickson City, Dickson City
Pocono Medical Center, East Stroudsburg
Saint Luke's Hospital-Anderson Campus, Easton
Saint Vincent Hospital, Erie
UPMC Hillman Cancer Center Erie, Erie
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg
Lehigh Valley Hospital-Hazleton, Hazleton
IRMC Cancer Center, Indiana
Jefferson Hospital, Jefferson Hills
UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown
Geisinger Medical Oncology-Lewisburg, Lewisburg
Yolanda G Barco Oncology Institute, Meadville
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg
Riddle Memorial Hospital, Media
Forbes Hospital, Monroeville
UPMC Hillman Cancer Center - Monroeville, Monroeville
UPMC Hillman Cancer Center in Coraopolis, Moon Township
Arnold Palmer Cancer Center Medical Oncology Norwin, N. Huntingdon
UPMC Cancer Center-Natrona Heights, Natrona Heights
Paoli Memorial Hospital, Paoli
Allegheny General Hospital, Pittsburgh
UPMC Hillman Cancer Center, Pittsburgh
UPMC-Magee Womens Hospital, Pittsburgh
UPMC-Passavant Hospital, Pittsburgh
UPMC-Saint Clair Hospital Cancer Center, Pittsburgh
UPMC-Saint Margaret, Pittsburgh
Saint Luke's Hospital - Upper Bucks Campus, Quakertown
Community Medical Center, Scranton
UPMC Cancer Center at UPMC Northwest, Seneca
Saint Luke's Hospital - Monroe Campus, Stroudsburg
UPMC Cancer Center-Washington, Washington
UPMC West Mifflin-Cancer Center Jefferson, West Mifflin
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
Divine Providence Hospital, Williamsport
Lankenau Medical Center, Wynnewood
UPMC Memorial, York
Rhode IslandWomen and Infants Hospital, Providence
Smilow Cancer Hospital Care Center - Westerly, Westerly
South CarolinaSaint Joseph's/Candler - Bluffton Campus, Bluffton
Prisma Health Cancer Institute - Spartanburg, Boiling Springs
Bon Secours Saint Francis Hospital, Charleston
Charleston Oncology - Roper, Charleston
Charleston Oncology - Saint Francis, Charleston
Medical University of South Carolina, Charleston
Roper Hospital, Charleston
Prisma Health Cancer Institute - Easley, Easley
Tidelands Georgetown Memorial Hospital, Georgetown
Prisma Health Cancer Institute - Butternut, Greenville
Prisma Health Cancer Institute - Eastside, Greenville
Prisma Health Cancer Institute - Faris, Greenville
Prisma Health Greenville Memorial Hospital, Greenville
Prisma Health Cancer Institute - Greer, Greer
South Carolina Cancer Specialists PC, Hilton Head Island
Prisma Health Cancer Institute - Seneca, Seneca
TennesseeBaptist Memorial Hospital and Cancer Center-Collierville, Collierville
Covenant Health Cancer Centers, Knoxville
Covenant Health Cancer Centers - West, Knoxville
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis
Covenant Health Oncology Group - Oak Ridge, Oak Ridge
TexasUT MD Anderson - The Woodlands, Conroe
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston
Ben Taub General Hospital, Houston
UT MD Anderson - West Houston, Houston
UT MD Anderson Cancer Center, Houston
UT MD Anderson - League City, League City
University of Texas Health Science Center at San Antonio, San Antonio
UT MD Anderson - Sugar Land, Sugar Land
VirginiaHematology Oncology Associates of Fredericksburg Inc, Fredericksburg
Bon Secours Memorial Regional Medical Center, Mechanicsville
Bon Secours Saint Francis Medical Center, Midlothian
Bon Secours Saint Mary's Hospital, Richmond
VCU Massey Cancer Center at Stony Point, Richmond
VCU Massey Comprehensive Cancer Center, Richmond
Virginia Cancer Institute, Richmond
VCU Community Memorial Health Center, South Hill
WashingtonSwedish Cancer Institute-Edmonds, Edmonds
Swedish Cancer Institute-Issaquah, Issaquah
Kadlec Clinic Hematology and Oncology, Kennewick
Providence Regional Cancer System-Lacey, Lacey
Swedish Medical Center-First Hill, Seattle
Northwest Medical Specialties PLLC, Tacoma
Legacy Cancer Institute Medical Oncology and Day Treatment, Vancouver
Legacy Salmon Creek Hospital, Vancouver
West VirginiaVandalia Health/CAMC Institute for Academic Medicine, Charleston
West Virginia University Healthcare, Morgantown
WisconsinAspirus Cancer Care-Antigo-Volm Cancer Center, Antigo
ThedaCare Regional Cancer Center, Appleton
Duluth Clinic Ashland, Ashland
Aurora Cancer Care-Southern Lakes VLCC, Burlington
Aurora Saint Luke's South Shore, Cudahy
Marshfield Medical Center-EC Cancer Center, Eau Claire
Aurora Health Care Germantown Health Center, Germantown
Aurora Cancer Care-Grafton, Grafton
Aurora BayCare Medical Center, Green Bay
Bellin Memorial Hospital, Green Bay
Saint Vincent Hospital Cancer Center Green Bay, Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay
Mercyhealth Hospital and Cancer Center - Janesville, Janesville
University of Wisconsin Carbone Cancer Center - Johnson Creek, Johnson Creek
Aurora Cancer Care-Kenosha South, Kenosha
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Aurora Bay Area Medical Group-Marinette, Marinette
Marshfield Medical Center-Marshfield, Marshfield
Aspirus Medford Hospital, Medford
Froedtert Menomonee Falls Hospital, Menomonee Falls
Aurora Cancer Care-Milwaukee, Milwaukee
Aurora Saint Luke's Medical Center, Milwaukee
Aurora Sinai Medical Center, Milwaukee
Medical College of Wisconsin, Milwaukee
Marshfield Medical Center - Minocqua, Minocqua
ThedaCare Regional Medical Center - Neenah, Neenah
Drexel Town Square Health Center, Oak Creek
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh
Aurora Cancer Care-Racine, Racine
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center, Rhinelander
Marshfield Medical Center-Rice Lake, Rice Lake
Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan
Essentia Health-Spooner Clinic, Spooner
Aspirus Cancer Care - Stevens Point, Stevens Point
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay
Aurora Medical Center in Summit, Summit
Essentia Health Saint Mary's Hospital - Superior, Superior
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers
Aspirus Cancer Care-Wausau, Wausau
Aurora Cancer Care-Milwaukee West, Wauwatosa
Aurora West Allis Medical Center, West Allis
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend
Marshfield Medical Center - Weston, Weston
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.