Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Sponsored by National Cancer Institute (NCI)
About this 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.
PRIMARY OBJECTIVE: I. To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. SECONDARY OBJECTIVES: I. To compare pathologic complete response rates (ypT0/is, ypN0) in participants randomized to standard of care chemotherapy alone versus (vs.) standard of care neoadjuvant chemotherapy concurrent with durvalumab. II. To compare residual cancer burden distribution between participants randomized to standard of care neoadjuvant chemotherapy vs. standard of care neoadjuvant chemotherapy concurrent with durvalumab. III. To compare distant relapse-free survival between participants randomized to standard of care neoadjuvant chemotherapy vs. sta…
Where this study is enrolling (537)
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama
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Katmai Oncology Group
Anchorage, Alaska
- Call 520-694-8900
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona
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Banner University Medical Center - Tucson
Tucson, Arizona
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University of Arizona Cancer Center-North Campus
Tucson, Arizona
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- Call 800-378-9373
Mercy Hospital Fort Smith
Fort Smith, Arkansas
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- Call 501-686-8274
University of Arkansas for Medical Sciences
Little Rock, Arkansas
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas
- Call 310-582-7448
Saint John's Cancer Institute
Santa Monica, California
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Sutter Solano Medical Center/Cancer Center
Vallejo, California
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SWOG
Sacramento, California
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UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California
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Memorial Medical Center
Modesto, California
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California
- Call 760-416-4730
Desert Regional Medical Center
Palm Springs, California
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- Call 661-323-4673
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California
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- Call 909-558-4050
Loma Linda University Medical Center
Loma Linda, California
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Tower Cancer Research Foundation
Beverly Hills, California
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Torrance Memorial Physician Network - Cancer Care
Torrance, California
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The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California
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Sutter Auburn Faith Hospital
Auburn, California
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Sutter Medical Center Sacramento
Sacramento, California
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California Pacific Medical Center-Pacific Campus
San Francisco, California
- Call 626-535-2420
Huntington Memorial Hospital
Pasadena, California
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- Call 707-521-3830
Providence Medical Foundation - Santa Rosa
Santa Rosa, California
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Mills Health Center
San Mateo, California
- Call 707-521-3830
Providence Santa Rosa Memorial Hospital
Santa Rosa, California
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Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California
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Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California
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Palo Alto Medical Foundation-Fremont
Fremont, California
- Call 818-981-3818
Cedars-Sinai Cancer - Tarzana
Tarzana, California
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Cedars-Sinai Medical Center
Los Angeles, California
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Sutter Pacific Medical Foundation
Santa Rosa, California
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Sutter Roseville Medical Center
Roseville, California
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City of Hope Antelope Valley
Lancaster, California
- Call 877-467-3411
City of Hope at Irvine Lennar
Irvine, California
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City of Hope at Long Beach Elm
Long Beach, California
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City of Hope Comprehensive Cancer Center
Duarte, California
- Call 877-467-3411
City of Hope Newport Beach
Newport Beach, California
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City of Hope South Bay
Torrance, California
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City of Hope South Pasadena
South Pasadena, California
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City of Hope Upland
Upland, California
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UCI Health - Yorba Linda
Yorba Linda, California
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California
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Palo Alto Medical Foundation Health Care
Palo Alto, California
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UCHealth Greeley Hospital
Greeley, Colorado
- Call 970-203-7083
Medical Center of the Rockies
Loveland, Colorado
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- Call 720-848-0650
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado
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Shaw Cancer Center
Edwards, Colorado
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Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado
- Call 970-297-6150
Poudre Valley Hospital
Fort Collins, Colorado
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UCHealth - Cherry Creek
Denver, Colorado
- Call 720-848-0650
UCHealth University of Colorado Hospital
Aurora, Colorado
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UCHealth Lone Tree Health Center
Lone Tree, Colorado
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Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut
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Yale University
New Haven, Connecticut
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Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut
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Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut
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Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut
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Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut
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Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut
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Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut
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Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut
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Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut
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Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut
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Beebe South Coastal Health Campus
Millville, Delaware
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Medical Oncology Hematology Consultants PA
Newark, Delaware
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Beebe Health Campus
Rehoboth Beach, Delaware
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Helen F Graham Cancer Center
Newark, Delaware
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Sibley Memorial Hospital
Washington D.C., District of Columbia
- Call 954-265-4325
Memorial Hospital West
Pembroke Pines, Florida
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Mount Sinai Medical Center
Miami Beach, Florida
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida
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Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida
- Call 855-314-8646
Morton Plant Hospital
Clearwater, Florida
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Winter Haven Hospital
Winter Haven, Florida
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Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida
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Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida
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Mease Countryside Hospital
Safety Harbor, Florida
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Schulze Family Foundation Cancer Clinic - Bonita Health Center
Bonita Springs, Florida
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Emory University Hospital Midtown
Atlanta, Georgia
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Grady Health System
Atlanta, Georgia
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Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia
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Emory Saint Joseph's Hospital
Atlanta, Georgia
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Emory Johns Creek Hospital
Johns Creek, Georgia
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Emory Decatur Hospital
Decatur, Georgia
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Memorial Health University Medical Center
Savannah, Georgia
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia
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Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho
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Saint Luke's Cancer Institute - Boise
Boise, Idaho
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Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho
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Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho
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Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho
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Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho
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Saint Luke's Cancer Institute - Meridian
Meridian, Idaho
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Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho
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Saint Luke's Cancer Institute - Nampa
Nampa, Idaho
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois
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Illinois CancerCare-Bloomington
Bloomington, Illinois
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Illinois CancerCare-Canton
Canton, Illinois
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Illinois CancerCare-Carthage
Carthage, Illinois
- Call 815-285-7800
Illinois CancerCare-Dixon
Dixon, Illinois
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Illinois CancerCare-Eureka
Eureka, Illinois
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Illinois CancerCare-Galesburg
Galesburg, Illinois
- Call 815-227-2633
OSF Saint Anthony Medical Center
Rockford, Illinois
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- Call 847-429-2907
Advocate Sherman Hospital
Elgin, Illinois
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- Call 708-799-9995
Advocate South Suburban Hospital
Hazel Crest, Illinois
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Northwestern University
Chicago, Illinois
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AMG Crystal Lake - Oncology
Crystal Lake, Illinois
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AMG Libertyville - Oncology
Libertyville, Illinois
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Northwestern Medicine Orland Park
Orland Park, Illinois
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Northwestern Medicine Oak Brook
Oak Brook, Illinois
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Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois
- Call 312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois
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UW Health Carbone Cancer Center Rockford
Rockford, Illinois
- Call 312-695-1102
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois
- Call 312-355-3046
University of Illinois
Chicago, Illinois
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Advocate Outpatient Center - Aurora
Aurora, Illinois
- Call 847-384-3621
Advocate Lutheran General Hospital
Park Ridge, Illinois
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Mount Sinai Hospital Medical Center
Chicago, Illinois
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Advocate Illinois Masonic Medical Center
Chicago, Illinois
- Call 847-842-4847
Advocate Good Shepherd Hospital
Barrington, Illinois
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Cancer Care Center of O'Fallon
O'Fallon, Illinois
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
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Carle at The Riverfront
Danville, Illinois
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Carle BroMenn Medical Center
Normal, Illinois
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Carle Cancer Center
Urbana, Illinois
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Carle Cancer Institute Normal
Normal, Illinois
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Carle Physician Group-Effingham
Effingham, Illinois
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
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Condell Memorial Hospital
Libertyville, Illinois
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Advocate Good Samaritan Hospital
Downers Grove, Illinois
- Call 800-323-8622
Advocate Christ Medical Center
Oak Lawn, Illinois
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Crossroads Cancer Center
Effingham, Illinois
- Call 309-779-2000
Trinity Medical Center
Moline, Illinois
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Decatur Memorial Hospital
Decatur, Illinois
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Memorial Hospital East
Shiloh, Illinois
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SIH Cancer Institute
Carterville, Illinois
- Call 708-226-4357
Loyola University Medical Center
Maywood, Illinois
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- Call 217-545-7929
Southern Illinois University School of Medicine
Springfield, Illinois
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- Call 800-444-7541
Springfield Clinic
Springfield, Illinois
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Springfield Memorial Hospital
Springfield, Illinois
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SSM Health Good Samaritan
Mount Vernon, Illinois
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Illinois CancerCare-Princeton
Princeton, Illinois
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Illinois CancerCare-Peru
Peru, Illinois
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Illinois CancerCare-Peoria
Peoria, Illinois
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Illinois CancerCare-Pekin
Pekin, Illinois
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Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois
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Illinois CancerCare-Macomb
Macomb, Illinois
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Illinois CancerCare - Washington
Washington, Illinois
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Northwest Cancer Center - Valparaiso
Valparaiso, Indiana
- I'm interested
Northwest Cancer Center - Crown Point
Crown Point, Indiana
- Call 219-924-8178
Northwest Oncology LLC
Dyer, Indiana
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Women's Diagnostic Center - Munster
Munster, Indiana
- Call 219-836-3349
The Community Hospital
Munster, Indiana
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Saint Mary Medical Center
Hobart, Indiana
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Saint Catherine Hospital
Indianapolis, Indiana
- Call 219-947-1795
Northwest Cancer Center - Hobart
Hobart, Indiana
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa
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- Call 515-241-3305
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa
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- Call 319-363-2690
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa
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- Call 515-282-2200
Broadlawns Medical Center
Des Moines, Iowa
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UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa
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Saint Anthony Regional Hospital
Carroll, Iowa
- Call 515-241-6727
Iowa Methodist Medical Center
Des Moines, Iowa
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- Call 319-365-4673
Mercy Hospital
Cedar Rapids, Iowa
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Mercy Medical Center - Des Moines
Des Moines, Iowa
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa
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University of Kansas Cancer Center-Overland Park
Overland Park, Kansas
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas
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University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas
- Call 785-295-8000
University of Kansas Health System Saint Francis Campus
Topeka, Kansas
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University of Kansas Cancer Center
Kansas City, Kansas
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The University of Kansas Cancer Center - Olathe
Olathe, Kansas
- Call 785-623-5774
HaysMed
Hays, Kansas
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Lawrence Memorial Hospital
Lawrence, Kansas
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Salina Regional Health Center
Salina, Kansas
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CommonSpirit Saint Joseph Medical Center - East Lexington
Lexington, Kentucky
- Call 859-523-1934
Baptist Health Corbin
Corbin, Kentucky
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- Call 859-257-3379
University of Kentucky/Markey Cancer Center
Lexington, Kentucky
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- Call 318-813-1406
Ochsner LSU Health - Cancer Treatment Center
Shreveport, Louisiana
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Ochsner LSU Health Monroe Medical Center
Monroe, Louisiana
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Touro Infirmary
New Orleans, Louisiana
- Call 337-898-6413
Abbeville General Hospital
Abbeville, Louisiana
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University Medical Center New Orleans
New Orleans, Louisiana
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LSU Health Sciences Center at Shreveport
Shreveport, Louisiana
- Call 240-964-1400
UPMC Western Maryland
Cumberland, Maryland
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- Call 410-553-8100
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland
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- Call 410-601-9083
Sinai Hospital of Baltimore
Baltimore, Maryland
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Mercy Medical Center
Baltimore, Maryland
- Call 800-888-8823
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland
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UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland
- Call 301-668-7043
FMH James M Stockman Cancer Institute
Frederick, Maryland
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland
- Call 410-871-6400
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland
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- Call 443-643-3010
UM Upper Chesapeake Medical Center
Bel Air, Maryland
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Tufts Medical Center
Boston, Massachusetts
- Call 978-922-3000
Beverly Hospital
Beverly, Massachusetts
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Lahey Clinic
Burlington, Massachusetts
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Lahey Clinic Peabody
Peabody, Massachusetts
- Call 978-283-4000
Addison Gilbert Hospital
Gloucester, Massachusetts
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Trinity Health Medical Center - Brighton
Brighton, Michigan
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Trinity Health Medical Center - Canton
Canton, Michigan
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Trinity Health Muskegon Hospital
Muskegon, Michigan
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan
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Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan
- Call 248-551-7695
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan
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Corewell Health Reed City Hospital
Reed City, Michigan
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Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan
- Call 616-391-1230
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan
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Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan
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Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan
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- Call 248-551-7695
Corewell Health Dearborn Hospital
Dearborn, Michigan
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- Call 248-551-7695
Corewell Health Beaumont Troy Hospital
Troy, Michigan
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Hurley Medical Center
Flint, Michigan
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Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan
- I'm interested
Henry Ford Warren Hospital - GLCMS
Warren, Michigan
- I'm interested
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan
- I'm interested
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan
- I'm interested
Henry Ford River District Hospital
East China Township, Michigan
- I'm interested
Henry Ford Medical Center-Fairlane
Dearborn, Michigan
- I'm interested
Henry Ford Medical Center-Columbus
Novi, Michigan
- I'm interested
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan
- I'm interested
Henry Ford Hospital
Detroit, Michigan
- I'm interested
Henry Ford Health Warren Hospital
Warren, Michigan
- I'm interested
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan
- I'm interested
Henry Ford Health Saint John Hospital
Detroit, Michigan
- I'm interested
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan
- I'm interested
Henry Ford Health Providence Novi Hospital
Novi, Michigan
- I'm interested
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan
- I'm interested
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan
- I'm interested
Genesys Hurley Cancer Institute
Flint, Michigan
- I'm interested
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan
- I'm interested
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan
- I'm interested
Chelsea Hospital
Chelsea, Michigan
- I'm interested
Cancer Hematology Centers - Flint
Flint, Michigan
- I'm interested
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan
- I'm interested
Bronson Methodist Hospital
Kalamazoo, Michigan
- I'm interested
Bronson Battle Creek
Battle Creek, Michigan
- I'm interested
Munson Medical Center
Traverse City, Michigan
- I'm interested
MyMichigan Medical Center Saginaw
Saginaw, Michigan
- I'm interested
MyMichigan Medical Center Tawas
Tawas City, Michigan
- Call 800-865-1125
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan
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- I'm interested
University of Michigan Health - Sparrow Lansing
Lansing, Michigan
- I'm interested
University of Michigan Health - West
Wyoming, Michigan
- I'm interested
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan
- I'm interested
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan
- I'm interested
Weisberg Cancer Treatment Center
Farmington Hills, Michigan
- I'm interested
West Michigan Cancer Center
Kalamazoo, Michigan
- I'm interested
Allegiance Health
Jackson, Michigan
- I'm interested
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan
- I'm interested
Huron Gastroenterology PC
Ypsilanti, Michigan
- I'm interested
Henry Ford Wyandotte Hospital
Wyandotte, Michigan
- I'm interested
United Hospital
Saint Paul, Minnesota
- I'm interested
Essentia Health - Deer River Clinic
Deer River, Minnesota
- Call 218-786-3308
Essentia Health Hibbing Clinic
Hibbing, Minnesota
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- I'm interested
Hennepin County Medical Center
Minneapolis, Minnesota
- I'm interested
Lakeview Hospital
Stillwater, Minnesota
- I'm interested
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota
- I'm interested
Ridgeview Medical Center
Waconia, Minnesota
- I'm interested
Mercy Hospital
Coon Rapids, Minnesota
- I'm interested
Regions Hospital
Saint Paul, Minnesota
- I'm interested
Saint John's Hospital - Healtheast
Maplewood, Minnesota
- I'm interested
North Memorial Medical Health Center
Robbinsdale, Minnesota
- I'm interested
Fairview Southdale Hospital
Edina, Minnesota
- I'm interested
Minnesota Oncology - Burnsville
Burnsville, Minnesota
- I'm interested
Minnesota Oncology - Edina
Edina, Minnesota
- I'm interested
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota
- I'm interested
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota
- I'm interested
Essentia Health Sandstone
Sandstone, Minnesota
- I'm interested
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota
- I'm interested
Saint Francis Regional Medical Center
Shakopee, Minnesota
- I'm interested
Essentia Health Virginia Clinic
Virginia, Minnesota
- I'm interested
Abbott-Northwestern Hospital
Minneapolis, Minnesota
- I'm interested
Saint Luke's Hospital of Duluth
Duluth, Minnesota
- I'm interested
Essentia Health Cancer Center
Duluth, Minnesota
- I'm interested
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi
- I'm interested
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi
- I'm interested
Baptist Cancer Center-Grenada
Grenada, Mississippi
- I'm interested
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi
- I'm interested
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi
- I'm interested
University of Kansas Cancer Center - North
Kansas City, Missouri
- Call 417-269-4520
CoxHealth South Hospital
Springfield, Missouri
This research site can be reached directly by phone. Call to ask about this study.
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- Call 314-251-7066
Mercy Hospital Saint Louis
St Louis, Missouri
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- I'm interested
Mercy Hospital South
St Louis, Missouri
- Call 888-446-3729
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri
This research site can be reached directly by phone. Call to ask about this study.
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- Call 314-996-5569
Missouri Baptist Medical Center
St Louis, Missouri
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- Call 314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri
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- Call 314-996-5569
Parkland Health Center - Farmington
Farmington, Missouri
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- I'm interested
Saint Francis Medical Center
Cape Girardeau, Missouri
- Call 314-996-5569
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri
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- I'm interested
Siteman Cancer Center at Christian Hospital
St Louis, Missouri
- I'm interested
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri
- I'm interested
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri
- I'm interested
Siteman Cancer Center-South County
St Louis, Missouri
- Call 816-404-4375
University Health Truman Medical Center
Kansas City, Missouri
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- Call 913-588-3671
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri
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- I'm interested
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri
- I'm interested
Washington University School of Medicine
St Louis, Missouri
- I'm interested
Billings Clinic Cancer Center
Billings, Montana
- I'm interested
Community Medical Center
Missoula, Montana
- I'm interested
Community Hospital of Anaconda
Anaconda, Montana
- I'm interested
Bozeman Health Deaconess Hospital
Bozeman, Montana
- I'm interested
Benefis Sletten Cancer Institute
Great Falls, Montana
- I'm interested
Renown Regional Medical Center
Reno, Nevada
- I'm interested
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire
- I'm interested
Monmouth Medical Center
Long Branch, New Jersey
- Call 908-522-2043
Overlook Hospital
Summit, New Jersey
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- I'm interested
Monmouth Medical Center Southern Campus
Lakewood, New Jersey
- I'm interested
Community Medical Center
Toms River, New Jersey
- Call 973-971-5990
Newton Medical Center
Newton, New Jersey
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- I'm interested
Newark Beth Israel Medical Center
Newark, New Jersey
- I'm interested
Jersey City Medical Center
Jersey City, New Jersey
- Call 973-971-5990
Chilton Medical Center
Pompton, New Jersey
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- I'm interested
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey
- Call 732-235-7356
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey
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- Call 732-235-7356
Rutgers New Jersey Medical School
Newark, New Jersey
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- Call 908-994-8000
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Elizabeth, New Jersey
This research site can be reached directly by phone. Call to ask about this study.
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- Call 609-631-6946
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey
This research site can be reached directly by phone. Call to ask about this study.
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- Call 973-971-5990
Hackettstown Medical Center
Hackettstown, New Jersey
This research site can be reached directly by phone. Call to ask about this study.
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- Call 973-971-5900
Morristown Medical Center
Morristown, New Jersey
This research site can be reached directly by phone. Call to ask about this study.
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- Call 631-638-7400
The Philips Family Cancer Center
Southampton, New York
This research site can be reached directly by phone. Call to ask about this study.
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- Call 315-464-5476
State University of New York Upstate Medical University
Syracuse, New York
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- Call 718-226-8888
Staten Island University Hospital
Staten Island, New York
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- Call 800-862-2215
Stony Brook University Medical Center
Stony Brook, New York
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- Call 315-464-5476
SUNY Upstate Medical Center-Community Campus
Syracuse, New York
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- Call 516-326-7514
Good Samaritan University Hospital
West Islip, New York
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- I'm interested
NYU Langone Hospital - Brooklyn
Brooklyn, New York
- I'm interested
The Cancer Institute at Saint Francis Hospital
East Hills, New York
- I'm interested
Northern Westchester Hospital
Mount Kisco, New York
- I'm interested
NYU Langone Hospital - Long Island
Mineola, New York
- I'm interested
Mount Sinai West
New York, New York
- I'm interested
Mount Sinai Hospital
New York, New York
- I'm interested
Mount Sinai Chelsea
New York, New York
- I'm interested
Upstate Cancer Center at Verona
Verona, New York
- I'm interested
Upstate Cancer Center at Oswego
Oswego, New York
- Call 914-366-1600
Phelps Memorial Hospital Center
Sleepy Hollow, New York
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- Call 212-434-4460
Manhattan Eye Ear and Throat Hospital
New York, New York
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- Call 516-734-8896
Lenox Hill Hospital
New York, New York
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- I'm interested
Dickstein Cancer Treatment Center
White Plains, New York
- I'm interested
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York
- I'm interested
UNC Health Cancer Care Cary
Cary, North Carolina
- I'm interested
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
- I'm interested
UNC Health Cancer Care Wakefield
Raleigh, North Carolina
- I'm interested
UNC Health Cancer Care Raleigh
Raleigh, North Carolina
- I'm interested
UNC Health Cancer Care Garner
Garner, North Carolina
- I'm interested
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina
- I'm interested
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina
- I'm interested
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina
- I'm interested
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina
- I'm interested
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota
- Call 937-569-7515
Miami Valley Cancer Care and Infusion
Greenville, Ohio
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- I'm interested
Ohio State University Comprehensive Cancer Center
Columbus, Ohio
- I'm interested
OhioHealth Mansfield Hospital
Mansfield, Ohio
- I'm interested
OhioHealth Marion General Hospital
Marion, Ohio
- I'm interested
OhioHealth Pickerington Methodist Hospital
Pickerington, Ohio
- I'm interested
Columbus Oncology and Hematology Associates
Dublin, Ohio
- I'm interested
OhioHealth Westerville Medical Campus/Westerville Cancer Center
Westerville, Ohio
- I'm interested
Grady Memorial Hospital
Delaware, Ohio
- I'm interested
Grant Medical Center
Columbus, Ohio
- I'm interested
ProMedica Flower Hospital
Sylvania, Ohio
- I'm interested
Delaware Health Center-Grady Cancer Center
Delaware, Ohio
- I'm interested
Doctors Hospital
Columbus, Ohio
- I'm interested
Miami Valley Hospital
Dayton, Ohio
- I'm interested
Miami Valley Hospital South
Centerville, Ohio
- I'm interested
Miami Valley Hospital North
Dayton, Ohio
- I'm interested
Dublin Methodist Hospital
Dublin, Ohio
- Call 937-276-8320
Premier Blood and Cancer Center
Dayton, Ohio
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- I'm interested
MetroHealth Medical Center
Cleveland, Ohio
- I'm interested
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio
- I'm interested
Riverside Methodist Hospital
Columbus, Ohio
- I'm interested
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio
- I'm interested
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
- Call 405-752-3402
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma
This research site can be reached directly by phone. Call to ask about this study.
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- Call 503-413-2150
Legacy Mount Hood Medical Center
Gresham, Oregon
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- I'm interested
Saint Charles Health System
Bend, Oregon
- I'm interested
Providence Saint Vincent Medical Center
Portland, Oregon
- I'm interested
Providence Portland Medical Center
Portland, Oregon
- Call 503-413-1742
Legacy Meridian Park Hospital
Tualatin, Oregon
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- I'm interested
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon
- I'm interested
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon
- I'm interested
Pocono Medical Center
East Stroudsburg, Pennsylvania
- I'm interested
Riddle Memorial Hospital
Media, Pennsylvania
- Call 610-776-4714
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania
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- I'm interested
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania
- Call 610-776-4714
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania
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- I'm interested
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania
- Call 484-503-4151
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania
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- Call 814-452-5000
Saint Vincent Hospital
Erie, Pennsylvania
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- I'm interested
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania
- I'm interested
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania
- I'm interested
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania
- I'm interested
Lankenau Medical Center
Wynnewood, Pennsylvania
- I'm interested
Jefferson Hospital
Jefferson Hills, Pennsylvania
- I'm interested
IRMC Cancer Center
Indiana, Pennsylvania
- I'm interested
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania
- I'm interested
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania
- I'm interested
Geisinger Medical Center
Danville, Pennsylvania
- I'm interested
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania
- Call 412-858-7746
Forbes Hospital
Monroeville, Pennsylvania
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- I'm interested
Divine Providence Hospital
Williamsport, Pennsylvania
- I'm interested
Community Medical Center
Scranton, Pennsylvania
- I'm interested
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania
- I'm interested
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania
- I'm interested
Yolanda G Barco Oncology Institute
Meadville, Pennsylvania
- Call 814-676-7900
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
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- Call 724-230-3030
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania
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- Call 724-838-1900
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania
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- I'm interested
UPMC Cancer Center-Washington
Washington, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania
- I'm interested
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania
- Call 412-647-8073
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania
This research site can be reached directly by phone. Call to ask about this study.
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- Call 717-724-6760
UPMC Memorial
York, Pennsylvania
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- I'm interested
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania
- Call 412-653-8100
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania
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- I'm interested
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania
- Call 814-534-4724
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania
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- Call 412-647-2811
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania
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- Call 412-367-6454
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania
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- Call 412-502-3920
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania
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- Call 412-784-4900
UPMC-Saint Margaret
Pittsburgh, Pennsylvania
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- Call 877-284-2000
Allegheny General Hospital
Pittsburgh, Pennsylvania
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- I'm interested
Paoli Memorial Hospital
Paoli, Pennsylvania
- I'm interested
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island
- Call 401-274-1122
Women and Infants Hospital
Providence, Rhode Island
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- I'm interested
Charleston Oncology - Saint Francis
Charleston, South Carolina
- I'm interested
Roper Hospital
Charleston, South Carolina
- I'm interested
Medical University of South Carolina
Charleston, South Carolina
- I'm interested
Bon Secours Saint Francis Hospital
Charleston, South Carolina
- I'm interested
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina
- I'm interested
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina
- I'm interested
Charleston Oncology - Roper
Charleston, South Carolina
- I'm interested
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina
- I'm interested
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina
- I'm interested
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina
- I'm interested
Prisma Health Cancer Institute - Easley
Easley, South Carolina
- I'm interested
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina
- I'm interested
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina
- I'm interested
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina
- I'm interested
Prisma Health Cancer Institute - Greer
Greer, South Carolina
- I'm interested
Prisma Health Cancer Institute - Faris
Greenville, South Carolina
- I'm interested
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee
- I'm interested
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee
- Call 865-331-1812
Covenant Health Cancer Centers - West
Knoxville, Tennessee
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- Call 865-331-1812
Covenant Health Oncology Group - Oak Ridge
Oak Ridge, Tennessee
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- Call 865-331-1812
Covenant Health Cancer Centers
Knoxville, Tennessee
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University of Texas Health Science Center at San Antonio
San Antonio, Texas
- Call 713-873-2000
Ben Taub General Hospital
Houston, Texas
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- I'm interested
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
- I'm interested
UT MD Anderson - West Houston
Houston, Texas
- I'm interested
UT MD Anderson - The Woodlands
Conroe, Texas
- I'm interested
UT MD Anderson Cancer Center
Houston, Texas
- I'm interested
UT MD Anderson - League City
League City, Texas
- I'm interested
UT MD Anderson - Sugar Land
Sugar Land, Texas
- I'm interested
Bon Secours Saint Mary's Hospital
Richmond, Virginia
- I'm interested
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia
- I'm interested
VCU Massey Comprehensive Cancer Center
Richmond, Virginia
- I'm interested
Bon Secours Saint Francis Medical Center
Midlothian, Virginia
- I'm interested
VCU Massey Cancer Center at Stony Point
Richmond, Virginia
- I'm interested
VCU Community Memorial Health Center
South Hill, Virginia
- I'm interested
Virginia Cancer Institute
Richmond, Virginia
- I'm interested
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia
- I'm interested
Swedish Medical Center-First Hill
Seattle, Washington
- I'm interested
Kadlec Clinic Hematology and Oncology
Kennewick, Washington
- I'm interested
Swedish Cancer Institute-Edmonds
Edmonds, Washington
- I'm interested
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington
- I'm interested
Swedish Cancer Institute-Issaquah
Issaquah, Washington
- Call 503-413-2150
Legacy Salmon Creek Hospital
Vancouver, Washington
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- I'm interested
Providence Regional Cancer System-Lacey
Lacey, Washington
- I'm interested
Northwest Medical Specialties PLLC
Tacoma, Washington
- I'm interested
West Virginia University Healthcare
Morgantown, West Virginia
- Call 304-388-9944
West Virginia University Charleston Division
Charleston, West Virginia
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Marshfield Medical Center - Minocqua
Minocqua, Wisconsin
- I'm interested
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin
- I'm interested
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin
- I'm interested
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin
- I'm interested
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin
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Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin
- Call 715-422-7718
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin
- Call 920-435-8326
Bellin Memorial Hospital
Green Bay, Wisconsin
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Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin
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Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin
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Aurora West Allis Medical Center
West Allis, Wisconsin
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Aurora Sinai Medical Center
Milwaukee, Wisconsin
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Aurora Saint Luke's South Shore
Cudahy, Wisconsin
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin
- I'm interested
Aurora Medical Center in Summit
Summit, Wisconsin
- I'm interested
Aurora Health Care Germantown Health Center
Germantown, Wisconsin
- I'm interested
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin
- I'm interested
Aurora Cancer Care-Racine
Racine, Wisconsin
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Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin
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Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin
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Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin
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Aurora Cancer Care-Grafton
Grafton, Wisconsin
- Call 414-805-3666
Medical College of Wisconsin
Milwaukee, Wisconsin
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University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin
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University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin
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Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin
- I'm interested
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin
- Call 877-405-6866
Aspirus Cancer Care-Wausau
Wausau, Wisconsin
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Aspirus Medford Hospital
Medford, Wisconsin
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Aurora BayCare Medical Center
Green Bay, Wisconsin
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Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin
- I'm interested
ThedaCare Regional Cancer Center
Appleton, Wisconsin
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ThedaCare Regional Medical Center - Neenah
Neenah, Wisconsin
- Call 414-805-0505
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin
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- Call 262-257-5100
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin
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Essentia Health-Spooner Clinic
Spooner, Wisconsin
- Call 701-364-6272
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin
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Duluth Clinic Ashland
Ashland, Wisconsin
- Call 414-805-0505
Drexel Town Square Health Center
Oak Creek, Wisconsin
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Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin
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Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin
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Marshfield Medical Center - Weston
Weston, Wisconsin
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.