Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
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
3 other identifiers
interventional
1,550
2 countries
217
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2017
Longer than P75 for phase_3
217 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedStudy Start
First participant enrolled
December 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
ExpectedApril 8, 2024
April 1, 2024
7 years
September 8, 2017
April 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free survival (EFS)
Time from randomization until event
From randomization until event, through study follow up to the time target number of events is obtained, up to 5 years
Secondary Outcomes (12)
Overall survival (OS)
From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
Following completion of neoadjuvant therapy (ypT0/Tis ypN0)
Distant disease-free survival (DDFS)
From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Disease-free survival (DFS)
From the first breast surgical procedure to the first disease recurrence or death from any cause
Frequency of Adverse Events
From beginning of study therapy to 90 days after last dose of study therapy
- +7 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORIV infusion once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Atezolizumab
EXPERIMENTALIV infusion, 1200mg, once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples from a research biospy as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies.
- The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
- Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining \< 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.)
- Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations.
- The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 testing result including PD-L1 indeterminate Patients will be classifies as positive, negative, or indeterminate for stratification purposes.
- Patients must be ≥ 18 years old.
- Patient may be female or male.
- The ECOG performance status must be 0-1.
- The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2-N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3.
- Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria:
- Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node\[s\] on imaging is negative)
- Nodal status - positive (FNA or core biopsy of the node\[s\] is cytologically or histologically suspicious or positive; Imaging is suspicious or abnormal but FNA or core biopsy was not performed.)
- Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor.
- Blood counts performed within 28 days prior to randomization must meet the following criteria:
- ANC must be ≥ 1500/mm3;
- +16 more criteria
You may not qualify if:
- Excisional biopsy or lumpectomy performed prior to study entry.
- FNA alone to diagnose the breast cancer.
- Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
- Definitive clinical or radiologic evidence of metastatic disease.
- Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
- Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
- Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
- Previous therapy with anthracyclines or taxanes for any malignancy.
- Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:
- Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
- History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy.
- Uncontrolled hypertension defined as sustained systolic BP \> 150 mmHg or diastolic BP \> 90 mmHg. (Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.) Patients requiring ≥ 3 BP medications are not eligible.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NSABP Foundation Inclead
- Genentech, Inc.collaborator
- Hoffmann-La Rochecollaborator
Study Sites (217)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Katmai Oncology Group
Anchorage, Alaska, 99508, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401, United States
St. Bernard's Medical Center
Paragould, Arkansas, 72450, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Arrowhead Regional Medical Center
Colton, California, 92324, United States
City of Hope
Duarte, California, 91010, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Kaiser Permanente-Harbor City
Harbor City, California, 90710, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
Kaiser Permanente-Sunset
Los Angeles, California, 90027, United States
Kaiser Permanente-West Los Angeles
Los Angeles, California, 90034, United States
Kaiser Permanente-Panorama City
Panorama City, California, 91402, United States
Kaiser Permanente-Riverside
Riverside, California, 92505, United States
Kaiser Permanente Medical Group
San Diego, California, 92108, United States
Kaiser Permanente-Zion
San Diego, California, 92120, United States
Kaiser Permanente - Otay
San Diego, California, 92153, United States
Kaiser Permanente- San Marcos
San Marcos, California, 92078, United States
City of Hope - South Pasadena
South Pasadena, California, 91030, United States
Torrance Memorial Physician Network
Torrance, California, 90505, United States
City of Hope - Upland
Upland, California, 91786, United States
PIH Health
Whittier, California, 90602, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367, United States
Mount Sinai Comprehensive Cancer Center Aventura
Aventura, Florida, 33180, United States
Memorial Healthcare System Office of Human Research
Hollywood, Florida, 33021, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Gwinnett Hospital System Center for Cancer Care
Duluth, Georgia, 30096, United States
Gwinnett Hospital System Center for Cancer Care
Lawrenceville, Georgia, 30046, United States
Gwinnett Hospital System Center for Cancer Care
Snellville, Georgia, 30078, United States
Illinois Cancer Care-Bloomington
Bloomington, Illinois, 61704, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Affiliated Oncologists
Chicago Ridge, Illinois, 60415, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Emhurst Memorial Nancy W. Knowles Cancer Center
Elmhurst, Illinois, 60126, United States
Illinois Cancer Care-Galesburg
Galesburg, Illinois, 61401, United States
Edward Cancer Center
Naperville, Illinois, 60540, United States
Illinois Cancer Care-Ottawa
Ottawa, Illinois, 61350, United States
Illinois Cancer Care PC
Peoria, Illinois, 61615, United States
Illinois Cancer Care-Peru
Peru, Illinois, 61354, United States
Edward Cancer Center Plainfield
Plainfield, Illinois, 60585, United States
Cancer Care Specialists of Central Illinois-Swansea
Swansea, Illinois, 62226, United States
Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd)
Fort Wayne, Indiana, 46804, United States
Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza)
Fort Wayne, Indiana, 46845, United States
Mercy Medical Center Hall-Perrine Cancer Center
Cedar Rapids, Iowa, 52403, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Susan B. Allen Memorial Hosptial
El Dorado, Kansas, 67042, United States
Cancer Center at Mercy - W. Laurel
Independence, Kansas, 67301, United States
Kingman Community Hospital
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
McPherson Center for Health
McPherson, Kansas, 67460, United States
Newton Medical Center
Newton, Kansas, 67114, United States
Labette Health
Parsons, Kansas, 67357, United States
Pratt Regional Medical Center
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Winfield Healthcare Center
Winfield, Kansas, 67156, United States
Norton Cancer Institute-Downtown
Louisville, Kentucky, 40202, United States
Norton Cancer Institute-Norton Healthcare Pavilion
Louisville, Kentucky, 40202, United States
University of Louisville-James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Baptist Health Louisville; Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Norton Cancer Institute-St Matthews
Louisville, Kentucky, 40207, United States
Norton Cancer Institute-Brownsboro
Louisville, Kentucky, 40241, United States
Ochsner Medical Center-Kenner
Kenner, Louisiana, 70065, United States
West Jefferson Medical Center Cancer Center
Marrero, Louisiana, 70072, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Harry and Jeanette Weinberg Cancer Center at Franklin Square
Baltimore, Maryland, 21237, United States
Maryland Oncology Hematology
Bethesda, Maryland, 20817, United States
Maryland Oncology - Hematology Brandywine
Brandywine, Maryland, 20613, United States
Maryland Oncology - Hematology PA
Columbia, Maryland, 21044, United States
Maryland Oncology - Hematology Frederick
Frederick, Maryland, 21702, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Maryland Oncology - Hematology PA
Lanham, Maryland, 20706, United States
Maryland Oncology Hematology
Rockville, Maryland, 20850, United States
Capital Hematology Oncology Associates
Silver Spring, Maryland, 20904, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
University of Maryland, St. Joseph Medical Center
Towson, Maryland, 21204, United States
Maryland Oncology Hematology
Wheaton, Maryland, 20902, United States
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
Pittsfield, Massachusetts, 01201, United States
Henry Ford Cancer Institute Brownstown
Brownstown, Michigan, 48183, United States
Henry Ford Cancer Institute Macomb Hospital
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Michigan State University
East Lansing, Michigan, 48823, United States
Henry Ford Allegiance Health
Jackson, Michigan, 49201, United States
Michigan State University-Breslin Cancer Center
Lansing, Michigan, 48910, United States
Henry Ford Medical Center Columbus
Novi, Michigan, 48377, United States
Henry Ford Hospital W Bloomfield
West Bloomfield, Michigan, 48322, United States
Henry Ford Cancer Institute Wyandotte Hospital
Wyandotte, Michigan, 48192, United States
University of Missouri-Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, 08043, United States
New York Oncology Hematology PC
Albany, New York, 12206, United States
Broome Oncolgy
Binghamton, New York, 13905, United States
Broome Oncology
Johnson City, New York, 13790, United States
Health Quest Medical Practice
Poughkeepsie, New York, 12601, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
RHOA of Cary
Cary, North Carolina, 27518, United States
Waverly Hematology Oncology
Cary, North Carolina, 27518, United States
Carolinas Medical Center-Levine Cancer Insitute
Charlotte, North Carolina, 28204, United States
Levine Cancer Center Institute Pineville
Charlotte, North Carolina, 28210, United States
RHOA of Garner
Garner, North Carolina, 27529, United States
UNC Regional Physicians Hematology and Oncolgoy
High Point, North Carolina, 27262, United States
FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Rex Cancer Center
Raleigh, North Carolina, 27607, United States
RHOA of Blue Ridge
Raleigh, North Carolina, 27607, United States
RCC of Wakefield
Raleigh, North Carolina, 27614, United States
Nash UNC Health Care - Danny Talbott Cancer Center
Rocky Mount, North Carolina, 28704, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Aultman Alliance Cancer Center
Alliance, Ohio, 44601, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Aultman Medical Group Hematology and Oncology
Canton, Ohio, 44710, United States
The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology
Columbus, Ohio, 43210, United States
The Stephanie Speilman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Kaiser Permanente Northwest-Oncology/Hematology
Portland, Oregon, 97227, United States
Northwest Cancer Specialists
Tigard, Oregon, 97223, United States
UPMC Hillman Cancer Center-Beaver
Beaver, Pennsylvania, 15009, United States
UPMC Hillman Cancer Center - Passavant North
Cranberry Township, Pennsylvania, 16066, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522, United States
Allegheny Cancer Institute St. Vincent
Erie, Pennsylvania, 16505, United States
St. Vincent Hospital
Erie, Pennsylvania, 16544, United States
UPMC Cancer Center Horizon
Farrell, Pennsylvania, 16121, United States
Wellspan Medical Oncology
Gettysburg, Pennsylvania, 17325, United States
UPMC Hillman Cancer Center- Mountain View
Greensburg, Pennsylvania, 15601, United States
UPMC Cancer Center Greenville
Greenville, Pennsylvania, 16125, United States
AHN Cancer Institute at Jefferson
Jefferson Hills, Pennsylvania, 15025, United States
Seechler Family Cancer Center
Lebanon, Pennsylvania, 17042, United States
Forbes Regional Hospital
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center UPMC East-Monroeville
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center Norwin
N. Huntingdon, Pennsylvania, 15642, United States
UPMC Hillman Cancer Center New Castle
New Castle, Pennsylvania, 16105, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
WPAON at AGH
Pittsburgh, Pennsylvania, 15212, United States
WPAON at WPH
Pittsburgh, Pennsylvania, 15212, United States
Magee-Women's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
UPCI Investigational Drug Services
Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center @ Passavant - HOA
Pittsburgh, Pennsylvania, 15237, United States
UPMC Hillman Cancer Center @ Passavant - OHA
Pittsburgh, Pennsylvania, 15237, United States
UPMC Hillman Cancer Center-Upper Saint Clair
Pittsburgh, Pennsylvania, 15243, United States
UPMC Cancer Center Northwest
Seneca, Pennsylvania, 16346, United States
UPMC Hillman Cancer Center - Uniontown
Uniontown, Pennsylvania, 15401, United States
UPMC Hillman Cancer Center-Washington
Washington, Pennsylvania, 15301, United States
Wexford Health & Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
Wellspan Health-York Cancer Center Oncology Research
York, Pennsylvania, 17403, United States
Women's and Infants Hospital
Providence, Rhode Island, 02905, United States
Gibbs Cancer Center and Research Institute - Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute-Sioux Falls
Sioux Falls, South Dakota, 57105, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Wellmont Cancer Institute
Johnson City, Tennessee, 37601, United States
Wellmont Cancer Institute
Kingsport, Tennessee, 37660, United States
Dell Seton Medical Center at the University of Texas-Seton Infusion Center
Austin, Texas, 72701, United States
Texas Oncology Bedford
Bedford, Texas, 76022, United States
Texas Oncology Carrollton
Carrollton, Texas, 75010, United States
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, 75203, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology Denton
Denton, Texas, 76201, United States
Texas Oncology Flower Mound
Flower Mound, Texas, 75028, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
Harris Health System-Smith Clinic
Houston, Texas, 77054, United States
Texas Oncology - McAllen South Second
McAllen, Texas, 78503, United States
Texas Oncology Midland Allison Cancer Center
Midland, Texas, 79701, United States
Texas Oncology Plano
Plano, Texas, 75075, United States
Texas Oncology - The Woodlands
The Woodlands, Texas, 77380, United States
Wellmont Medical Associates-Oncology and Hematology
Bristol, Virginia, 24201, United States
Virginia Cancer Care Specialist
Leesburg, Virginia, 20176, United States
Centra Lynchburg Hematology Oncology
Lynchburg, Virginia, 24501, United States
Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Bon Secours St Francis Medical Center
Midlothian, Virginia, 23114, United States
Southwest Virginia Regional Cancer Center
Norton, Virginia, 24273, United States
Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital
Richmond, Virginia, 23226, United States
MRCC Auburn
Auburn, Washington, 98001, United States
MRCC Gig Harbor
Gig Harbor, Washington, 98335, United States
MRCC Puyallup
Puyallup, Washington, 98372, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
CAMC Health Education and Research Institute
Charleston, West Virginia, 25304, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Aurora Cancer Care-Southern Lakes
Burlington, Wisconsin, 53105, United States
Aurora Health Center Fond du Lac
Fond du Lac, Wisconsin, 54937, United States
Aurora Cancer Care-Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Aurora Cancer Care
Milwaukee, Wisconsin, 53209, United States
Aurora Cancer Care-Milwaukee South
Milwaukee, Wisconsin, 53215, United States
Aurora St. Lukes Medical Center-Pharmacy Only
Milwaukee, Wisconsin, 53215, United States
Aurora West Allis Medical Center
Milwaukee, Wisconsin, 53227, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Vince Lombardi Cancer Clinic Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Vince Lombardi Cancer Clinic Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aurora Cancer Care
Wauwatosa, Wisconsin, 53226, United States
CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont
Montreal, Quebec, H1T2M4, Canada
Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu
Montreal, Quebec, H2XOA9, Canada
SMBD-Jewish General Hospital (MPSG)
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, H4A3J1, Canada
CHU de Quebec-Hospital du Saint-Sacrement
Québec, Quebec, G1S4L8, Canada
Related Publications (1)
Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
PMID: 32450725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Wolmark, MD
NSBP Foundation, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2017
First Posted
September 13, 2017
Study Start
December 19, 2017
Primary Completion
December 31, 2024
Study Completion (Estimated)
November 30, 2027
Last Updated
April 8, 2024
Record last verified: 2024-04