1,550
Participants
Start Date
December 19, 2017
Primary Completion Date
December 31, 2024
Study Completion Date
November 30, 2027
Placebo
"Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + placebo IV Day 1 every 3 weeks for 4 doses.~Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.~\+ placebo IV Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.~Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by placebo IV Day 1 every 3 weeks after surgery until 1 year after the first dose."
Atezolizumab
"Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + Atezolizumab 1200 mg Day 1 every 3 weeks for 4 doses.~Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.~\+ Atezolizumab 1200 mg Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.~Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by Atezolizumab 1200 mg Day 1 every 3 weeks after surgery until 1 year after the first dose."
New York Oncology Hematology PC, Albany
Health Quest Medical Practice, Poughkeepsie
Vassar Brothers Medical Center, Poughkeepsie
Broome Oncology, Johnson City
Broome Oncolgy, Binghamton
UPMC Hillman Cancer Center-Beaver, Beaver
AHN Cancer Institute at Jefferson, Jefferson Hills
Wexford Health & Wellness Pavilion, Wexford
Forbes Regional Hospital, Monroeville
UPMC Hillman Cancer Center UPMC East-Monroeville, Monroeville
Allegheny General Hospital, Pittsburgh
WPAON at AGH, Pittsburgh
WPAON at WPH, Pittsburgh
Magee-Women's Hospital of Pittsburgh, Pittsburgh
Western Pennsylvania Hospital, Pittsburgh
UPCI Investigational Drug Services, Pittsburgh
UPMC Hillman Cancer Center @ Passavant - HOA, Pittsburgh
UPMC Hillman Cancer Center @ Passavant - OHA, Pittsburgh
UPMC Hillman Cancer Center-Upper Saint Clair, Pittsburgh
UPMC Hillman Cancer Center-Washington, Washington
UPMC Hillman Cancer Center - Uniontown, Uniontown
UPMC Hillman Cancer Center- Mountain View, Greensburg
UPMC Hillman Cancer Center Norwin, N. Huntingdon
UPMC Hillman Cancer Center - Passavant North, Cranberry Township
UPMC Hillman Cancer Center New Castle, New Castle
UPMC Cancer Center Horizon, Farrell
UPMC Cancer Center Greenville, Greenville
UPMC Cancer Center Northwest, Seneca
Allegheny Cancer Institute St. Vincent, Erie
St. Vincent Hospital, Erie
Seechler Family Cancer Center, Lebanon
Wellspan Medical Oncology, Gettysburg
Cancer Care Associates of York, York
Wellspan Health-York Cancer Center Oncology Research, York
Ephrata Cancer Center, Ephrata
Virginia Cancer Care Specialist, Leesburg
Maryland Oncology - Hematology Brandywine, Brandywine
Maryland Oncology - Hematology PA, Lanham
Maryland Oncology Hematology, Bethesda
Maryland Oncology Hematology, Rockville
Maryland Oncology Hematology, Wheaton
Capital Hematology Oncology Associates, Silver Spring
Holy Cross Hospital, Silver Spring
Maryland Oncology - Hematology PA, Columbia
Greater Baltimore Medical Center, Baltimore
University of Maryland, St. Joseph Medical Center, Towson
Medstar Union Memorial Hospital, Baltimore
Harry and Jeanette Weinberg Cancer Center at Franklin Square, Baltimore
Maryland Oncology - Hematology Frederick, Frederick
Meritus Center for Clinical Research, Hagerstown
Bon Secours St Francis Medical Center, Midlothian
Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center, Mechanicsville
Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital, Richmond
Wellmont Medical Associates-Oncology and Hematology, Bristol
Southwest Virginia Regional Cancer Center, Norton
Centra Lynchburg Hematology Oncology, Lynchburg
CAMC Health Education and Research Institute, Charleston
West Virginia University, Morgantown
UNC Regional Physicians Hematology and Oncolgoy, High Point
RHOA of Cary, Cary
Waverly Hematology Oncology, Cary
RHOA of Garner, Garner
Rex Cancer Center, Raleigh
RHOA of Blue Ridge, Raleigh
RCC of Wakefield, Raleigh
Carolinas Medical Center-Levine Cancer Insitute, Charlotte
Levine Cancer Center Institute Pineville, Charlotte
FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center, Pinehurst
Nash UNC Health Care - Danny Talbott Cancer Center, Rocky Mount
Spartanburg Medical Center, Spartanburg
Gibbs Cancer Center and Research Institute - Pelham, Greer
Gwinnett Hospital System Center for Cancer Care, Lawrenceville
Gwinnett Hospital System Center for Cancer Care, Snellville
Gwinnett Hospital System Center for Cancer Care, Duluth
UF Health Cancer Center at Orlando Health, Orlando
Memorial Healthcare System Office of Human Research, Hollywood
Mount Sinai Comprehensive Cancer Center, Miami Beach
Mount Sinai Comprehensive Cancer Center Aventura, Aventura
University of South Alabama Mitchell Cancer Institute, Mobile
Wellmont Cancer Institute, Johnson City
Wellmont Cancer Institute, Kingsport
Norton Cancer Institute-Downtown, Louisville
Norton Cancer Institute-Norton Healthcare Pavilion, Louisville
University of Louisville-James Graham Brown Cancer Center, Louisville
Baptist Health Louisville; Consultants in Blood Disorders and Cancer, Louisville
Norton Cancer Institute-St Matthews, Louisville
Norton Cancer Institute-Brownsboro, Louisville
The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology, Columbus
The Stephanie Speilman Comprehensive Breast Center, Columbus
Aultman Alliance Cancer Center, Alliance
Aultman Hospital, Canton
Aultman Medical Group Hematology and Oncology, Canton
Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd), Fort Wayne
Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza), Fort Wayne
Henry Ford Cancer Institute Macomb Hospital, Clinton Township
Henry Ford Medical Center Fairlane, Dearborn
Henry Ford Cancer Institute Brownstown, Brownstown
Henry Ford Cancer Institute Wyandotte Hospital, Wyandotte
Henry Ford Hospital, Detroit
Henry Ford Hospital W Bloomfield, West Bloomfield
Henry Ford Medical Center Columbus, Novi
Michigan State University, East Lansing
Michigan State University-Breslin Cancer Center, Lansing
Henry Ford Allegiance Health, Jackson
Mercy Medical Center Hall-Perrine Cancer Center, Cedar Rapids
Aurora Cancer Care-Germantown Health Center, Germantown
Aurora Cancer Care-Grafton, Grafton
Aurora Medical Center in Summit, Summit
Vince Lombardi Cancer Clinic Sheboygan, Sheboygan
Aurora Cancer Care-Southern Lakes, Burlington
Aurora Cancer Care-Kenosha South, Kenosha
Aurora Cancer Care, Milwaukee
Aurora Cancer Care-Milwaukee South, Milwaukee
Aurora St. Lukes Medical Center-Pharmacy Only, Milwaukee
Aurora Cancer Care, Wauwatosa
Aurora West Allis Medical Center, Milwaukee
Aurora Sinai Medical Center, Milwaukee
Aurora Cancer Care-Racine, Racine
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers
Aurora BayCare Medical Center, Green Bay
Vince Lombardi Cancer Clinic Oshkosh, Oshkosh
Aurora Health Center Fond du Lac, Fond du Lac
Sanford Cancer Center Oncology Clinic, Sioux Falls
Avera Cancer Institute-Sioux Falls, Sioux Falls
Avera Cancer Institute, Sioux Falls
Sanford Roger Maris Cancer Center, Fargo
Emhurst Memorial Nancy W. Knowles Cancer Center, Elmhurst
Affiliated Oncologists, Chicago Ridge
Edward Cancer Center, Naperville
Edward Cancer Center Plainfield, Plainfield
John H. Stroger, Jr. Hospital of Cook County, Chicago
Rush University Medical Center, Chicago
Illinois Cancer Care-Ottawa, Ottawa
Illinois Cancer Care-Peru, Peru
Illinois Cancer Care-Galesburg, Galesburg
Illinois Cancer Care PC, Peoria
Illinois Cancer Care-Bloomington, Bloomington
Cancer Care Specialists of Central Illinois-Swansea, Swansea
Crossroads Cancer Center, Effingham
Cancer Care Specialists of Central Illinois, Decatur
Decatur Memorial Hospital, Decatur
University of Missouri-Ellis Fischel Cancer Center, Columbia
Cancer Center of Kansas - Chanute, Chanute
Susan B. Allen Memorial Hosptial, El Dorado
Kingman Community Hospital, Kingman
Newton Medical Center, Newton
Pratt Regional Medical Center, Pratt
Winfield Healthcare Center, Winfield
Cancer Center of Kansas - Wichita, Wichita
Cancer Center of Kansas, Wichita
Cancer Center at Mercy - W. Laurel, Independence
Labette Health, Parsons
Cancer Center of Kansas - Salina, Salina
McPherson Center for Health, McPherson
Cancer Center of Kansas - Dodge City, Dodge City
Southwest Medical Center, Liberal
Ochsner Medical Center-Kenner, Kenner
West Jefferson Medical Center Cancer Center, Marrero
University Medical Center New Orleans, New Orleans
Ochsner Medical Center, New Orleans
St. Bernard's Medical Center, Jonesboro
St. Bernard's Medical Center, Paragould
Dell Seton Medical Center at the University of Texas-Seton Infusion Center, Austin
Texas Oncology Carrollton, Carrollton
Texas Oncology Flower Mound, Flower Mound
Texas Oncology Plano, Plano
Texas Oncology - Methodist Dallas Cancer Center, Dallas
Texas Oncology - Medical City Dallas, Dallas
Texas Oncology Dallas Presbyterian Hospital, Dallas
Texas Oncology Bedford, Bedford
Texas Oncology Denton, Denton
Baylor College of Medicine, Houston
Houston Methodist Cancer Center, Houston
Harris Health System-Smith Clinic, Houston
Texas Oncology - The Woodlands, The Woodlands
Texas Oncology - McAllen South Second, McAllen
Texas Oncology Midland Allison Cancer Center, Midland
Kaiser Permanente-Sunset, Los Angeles
Kaiser Permanente-West Los Angeles, Los Angeles
Torrance Memorial Physician Network, Torrance
PIH Health, Whittier
Kaiser Permanente-Bellflower, Bellflower
Kaiser Permanente-Harbor City, Harbor City
Cancer and Blood Specialty Clinic, Los Alamitos
City of Hope, Duarte
City of Hope - South Pasadena, South Pasadena
Kaiser Permanente-Woodland Hills, Woodland Hills
Kaiser Permanente-Panorama City, Panorama City
Kaiser Permanente-Baldwin Park, Baldwin Park
City of Hope - Upland, Upland
Kaiser Permanente- San Marcos, San Marcos
Kaiser Permanente Medical Group, San Diego
Kaiser Permanente-Zion, San Diego
Kaiser Permanente - Otay, San Diego
Arrowhead Regional Medical Center, Colton
Kaiser Permanente-Fontana, Fontana
Kaiser Permanente-Riverside, Riverside
Kaiser Permanente-Irvine, Irvine
Kaiser Permanente-Anaheim, Anaheim
Northwest Cancer Specialists, Tigard
Kaiser Permanente Northwest-Oncology/Hematology, Portland
Willamette Valley Cancer Institute and Research Center, Eugene
MRCC Auburn, Auburn
MRCC Gig Harbor, Gig Harbor
MRCC Puyallup, Puyallup
MultiCare Health System, Tacoma
MultiCare Institute for Research & Innovation, Tacoma
Katmai Oncology Group, Anchorage
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center, Pittsfield
Newark Beth Israel Medical Center, Newark
MD Anderson Cancer Center at Cooper, Voorhees Township
Women's and Infants Hospital, Providence
CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont, Montreal
Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu, Montreal
SMBD-Jewish General Hospital (MPSG), Montreal
McGill University Health Centre-Cedars Cancer Centre, Montreal
CHU de Quebec-Hospital du Saint-Sacrement, Québec
Collaborators (1)
Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
NSABP Foundation Inc
NETWORK