Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03281954
PHASE3

Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

Sponsor: NSABP Foundation Inc

View on ClinicalTrials.gov

Summary

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery. Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

Official title: A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1550

Start Date

2017-12-19

Completion Date

2027-11-30

Last Updated

2024-04-08

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (217)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Katmai Oncology Group

Anchorage, Alaska, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

St. Bernard's Medical Center

Paragould, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Arrowhead Regional Medical Center

Colton, California, United States

City of Hope

Duarte, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente-Harbor City

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Kaiser Permanente-Sunset

Los Angeles, California, United States

Kaiser Permanente-West Los Angeles

Los Angeles, California, United States

Kaiser Permanente-Panorama City

Panorama City, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Kaiser Permanente Medical Group

San Diego, California, United States

Kaiser Permanente-Zion

San Diego, California, United States

Kaiser Permanente - Otay

San Diego, California, United States

Kaiser Permanente- San Marcos

San Marcos, California, United States

City of Hope - South Pasadena

South Pasadena, California, United States

Torrance Memorial Physician Network

Torrance, California, United States

City of Hope - Upland

Upland, California, United States

PIH Health

Whittier, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Mount Sinai Comprehensive Cancer Center Aventura

Aventura, Florida, United States

Memorial Healthcare System Office of Human Research

Hollywood, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

UF Health Cancer Center at Orlando Health

Orlando, Florida, United States

Gwinnett Hospital System Center for Cancer Care

Duluth, Georgia, United States

Gwinnett Hospital System Center for Cancer Care

Lawrenceville, Georgia, United States

Gwinnett Hospital System Center for Cancer Care

Snellville, Georgia, United States

Illinois Cancer Care-Bloomington

Bloomington, Illinois, United States

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Affiliated Oncologists

Chicago Ridge, Illinois, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Emhurst Memorial Nancy W. Knowles Cancer Center

Elmhurst, Illinois, United States

Illinois Cancer Care-Galesburg

Galesburg, Illinois, United States

Edward Cancer Center

Naperville, Illinois, United States

Illinois Cancer Care-Ottawa

Ottawa, Illinois, United States

Illinois Cancer Care PC

Peoria, Illinois, United States

Illinois Cancer Care-Peru

Peru, Illinois, United States

Edward Cancer Center Plainfield

Plainfield, Illinois, United States

Cancer Care Specialists of Central Illinois-Swansea

Swansea, Illinois, United States

Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd)

Fort Wayne, Indiana, United States

Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza)

Fort Wayne, Indiana, United States

Mercy Medical Center Hall-Perrine Cancer Center

Cedar Rapids, Iowa, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Susan B. Allen Memorial Hosptial

El Dorado, Kansas, United States

Cancer Center at Mercy - W. Laurel

Independence, Kansas, United States

Kingman Community Hospital

Kingman, Kansas, United States

Southwest Medical Center

Liberal, Kansas, United States

McPherson Center for Health

McPherson, Kansas, United States

Newton Medical Center

Newton, Kansas, United States

Labette Health

Parsons, Kansas, United States

Pratt Regional Medical Center

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Winfield Healthcare Center

Winfield, Kansas, United States

Norton Cancer Institute-Downtown

Louisville, Kentucky, United States

Norton Cancer Institute-Norton Healthcare Pavilion

Louisville, Kentucky, United States

University of Louisville-James Graham Brown Cancer Center

Louisville, Kentucky, United States

Baptist Health Louisville; Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Norton Cancer Institute-St Matthews

Louisville, Kentucky, United States

Norton Cancer Institute-Brownsboro

Louisville, Kentucky, United States

Ochsner Medical Center-Kenner

Kenner, Louisiana, United States

West Jefferson Medical Center Cancer Center

Marrero, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Harry and Jeanette Weinberg Cancer Center at Franklin Square

Baltimore, Maryland, United States

Maryland Oncology Hematology

Bethesda, Maryland, United States

Maryland Oncology - Hematology Brandywine

Brandywine, Maryland, United States

Maryland Oncology - Hematology PA

Columbia, Maryland, United States

Maryland Oncology - Hematology Frederick

Frederick, Maryland, United States

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Maryland Oncology - Hematology PA

Lanham, Maryland, United States

Maryland Oncology Hematology

Rockville, Maryland, United States

Capital Hematology Oncology Associates

Silver Spring, Maryland, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

University of Maryland, St. Joseph Medical Center

Towson, Maryland, United States

Maryland Oncology Hematology

Wheaton, Maryland, United States

Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center

Pittsfield, Massachusetts, United States

Henry Ford Cancer Institute Brownstown

Brownstown, Michigan, United States

Henry Ford Cancer Institute Macomb Hospital

Clinton Township, Michigan, United States

Henry Ford Medical Center Fairlane

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Michigan State University

East Lansing, Michigan, United States

Henry Ford Allegiance Health

Jackson, Michigan, United States

Michigan State University-Breslin Cancer Center

Lansing, Michigan, United States

Henry Ford Medical Center Columbus

Novi, Michigan, United States

Henry Ford Hospital W Bloomfield

West Bloomfield, Michigan, United States

Henry Ford Cancer Institute Wyandotte Hospital

Wyandotte, Michigan, United States

University of Missouri-Ellis Fischel Cancer Center

Columbia, Missouri, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

MD Anderson Cancer Center at Cooper

Voorhees Township, New Jersey, United States

New York Oncology Hematology PC

Albany, New York, United States

Broome Oncolgy

Binghamton, New York, United States

Broome Oncology

Johnson City, New York, United States

Health Quest Medical Practice

Poughkeepsie, New York, United States

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

RHOA of Cary

Cary, North Carolina, United States

Waverly Hematology Oncology

Cary, North Carolina, United States

Carolinas Medical Center-Levine Cancer Insitute

Charlotte, North Carolina, United States

Levine Cancer Center Institute Pineville

Charlotte, North Carolina, United States

RHOA of Garner

Garner, North Carolina, United States

UNC Regional Physicians Hematology and Oncolgoy

High Point, North Carolina, United States

FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

Rex Cancer Center

Raleigh, North Carolina, United States

RHOA of Blue Ridge

Raleigh, North Carolina, United States

RCC of Wakefield

Raleigh, North Carolina, United States

Nash UNC Health Care - Danny Talbott Cancer Center

Rocky Mount, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Aultman Alliance Cancer Center

Alliance, Ohio, United States

Aultman Hospital

Canton, Ohio, United States

Aultman Medical Group Hematology and Oncology

Canton, Ohio, United States

The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology

Columbus, Ohio, United States

The Stephanie Speilman Comprehensive Breast Center

Columbus, Ohio, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Kaiser Permanente Northwest-Oncology/Hematology

Portland, Oregon, United States

Northwest Cancer Specialists

Tigard, Oregon, United States

UPMC Hillman Cancer Center-Beaver

Beaver, Pennsylvania, United States

UPMC Hillman Cancer Center - Passavant North

Cranberry Township, Pennsylvania, United States

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Allegheny Cancer Institute St. Vincent

Erie, Pennsylvania, United States

St. Vincent Hospital

Erie, Pennsylvania, United States

UPMC Cancer Center Horizon

Farrell, Pennsylvania, United States

Wellspan Medical Oncology

Gettysburg, Pennsylvania, United States

UPMC Hillman Cancer Center- Mountain View

Greensburg, Pennsylvania, United States

UPMC Cancer Center Greenville

Greenville, Pennsylvania, United States

AHN Cancer Institute at Jefferson

Jefferson Hills, Pennsylvania, United States

Seechler Family Cancer Center

Lebanon, Pennsylvania, United States

Forbes Regional Hospital

Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center UPMC East-Monroeville

Monroeville, Pennsylvania, United States

UPMC Hillman Cancer Center Norwin

N. Huntingdon, Pennsylvania, United States

UPMC Hillman Cancer Center New Castle

New Castle, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

WPAON at AGH

Pittsburgh, Pennsylvania, United States

WPAON at WPH

Pittsburgh, Pennsylvania, United States

Magee-Women's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

UPCI Investigational Drug Services

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center @ Passavant - HOA

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center @ Passavant - OHA

Pittsburgh, Pennsylvania, United States

UPMC Hillman Cancer Center-Upper Saint Clair

Pittsburgh, Pennsylvania, United States

UPMC Cancer Center Northwest

Seneca, Pennsylvania, United States

UPMC Hillman Cancer Center - Uniontown

Uniontown, Pennsylvania, United States

UPMC Hillman Cancer Center-Washington

Washington, Pennsylvania, United States

Wexford Health & Wellness Pavilion

Wexford, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

Wellspan Health-York Cancer Center Oncology Research

York, Pennsylvania, United States

Women's and Infants Hospital

Providence, Rhode Island, United States

Gibbs Cancer Center and Research Institute - Pelham

Greer, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Avera Cancer Institute-Sioux Falls

Sioux Falls, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Wellmont Cancer Institute

Johnson City, Tennessee, United States

Wellmont Cancer Institute

Kingsport, Tennessee, United States

Dell Seton Medical Center at the University of Texas-Seton Infusion Center

Austin, Texas, United States

Texas Oncology Bedford

Bedford, Texas, United States

Texas Oncology Carrollton

Carrollton, Texas, United States

Texas Oncology - Methodist Dallas Cancer Center

Dallas, Texas, United States

Texas Oncology - Medical City Dallas

Dallas, Texas, United States

Texas Oncology Dallas Presbyterian Hospital

Dallas, Texas, United States

Texas Oncology Denton

Denton, Texas, United States

Texas Oncology Flower Mound

Flower Mound, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States

Harris Health System-Smith Clinic

Houston, Texas, United States

Texas Oncology - McAllen South Second

McAllen, Texas, United States

Texas Oncology Midland Allison Cancer Center

Midland, Texas, United States

Texas Oncology Plano

Plano, Texas, United States

Texas Oncology - The Woodlands

The Woodlands, Texas, United States

Wellmont Medical Associates-Oncology and Hematology

Bristol, Virginia, United States

Virginia Cancer Care Specialist

Leesburg, Virginia, United States

Centra Lynchburg Hematology Oncology

Lynchburg, Virginia, United States

Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center

Mechanicsville, Virginia, United States

Bon Secours St Francis Medical Center

Midlothian, Virginia, United States

Southwest Virginia Regional Cancer Center

Norton, Virginia, United States

Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital

Richmond, Virginia, United States

MRCC Auburn

Auburn, Washington, United States

MRCC Gig Harbor

Gig Harbor, Washington, United States

MRCC Puyallup

Puyallup, Washington, United States

MultiCare Health System

Tacoma, Washington, United States

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States

CAMC Health Education and Research Institute

Charleston, West Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Aurora Cancer Care-Southern Lakes

Burlington, Wisconsin, United States

Aurora Health Center Fond du Lac

Fond du Lac, Wisconsin, United States

Aurora Cancer Care-Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Aurora Cancer Care

Milwaukee, Wisconsin, United States

Aurora Cancer Care-Milwaukee South

Milwaukee, Wisconsin, United States

Aurora St. Lukes Medical Center-Pharmacy Only

Milwaukee, Wisconsin, United States

Aurora West Allis Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Vince Lombardi Cancer Clinic Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Vince Lombardi Cancer Clinic Sheboygan

Sheboygan, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Aurora Cancer Care

Wauwatosa, Wisconsin, United States

CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont

Montreal, Quebec, Canada

Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu

Montreal, Quebec, Canada

SMBD-Jewish General Hospital (MPSG)

Montreal, Quebec, Canada

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, Canada

CHU de Quebec-Hospital du Saint-Sacrement

Québec, Quebec, Canada