Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

March 21, 2024 updated by: National Cancer Institute (NCI)

A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, 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. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.

Study Overview

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the progression-free survival (PFS), assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, relative to the addition of a placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) in patients with newly documented HER2-positive measurable metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the overall survival (OS) relative to the addition of placebo to a regimen of pertuzumab and trastuzumab, combined with a taxane (paclitaxel or docetaxel).

II. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the overall objective response (OR) in the cohort of patients randomized 6 months or more prior to study accrual closure assessed by investigator using RECIST 1.1 criteria, relative to the addition of placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel).

III. To determine the immune-related toxicity profile of the two treatment regimens.

IV. To determine the cardiac safety profile of the two treatment regimens.

EXPLORATORY OBJECTIVES:

I. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will decrease the incidence of subsequent brain metastases in patients without known brain metastases at study entry relative to the addition of a placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel).

II. To determine the utility of PD-L1 immunohistochemistry (IHC) staining as a predictive and prognostic biomarker associated with clinical response, as assessed by investigator using RECIST 1.1 criteria, to atezolizumab in combination with trastuzumab and pertuzumab combined with a taxane (paclitaxel or docetaxel).

III. To identify potential biomarkers that can predict benefit from the addition of atezolizumab in patients with newly documented HER2-positive measurable metastatic breast cancer treated with a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel).

IV. To explore the toxicity profile of the two treatment regimens using patient-reported symptomatic adverse events in addition to standard adverse event reports.

V. To determine the feasibility and added value of frequent assessment of toxicity using Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) with electronic(e)PRO reporting.

VI. To explore whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will contribute to increased patient-reported fatigue in comparison to the addition of placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel).

OUTLINE:

STEP 1: Patients receive pertuzumab intravenously (IV) over 30-60 minutes on days 1 and 22, trastuzumab IV over 30-90 minutes on days 1 and 22, and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 or docetaxel IV over 60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo a biopsy at baseline. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or bone scan at baseline.

STEP 2: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive pertuzumab IV over 30-60 minutes on days 1 and 22 of each cycle, trastuzumab IV over 30-90 minutes on days 1 and 22 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 of each cycle or docetaxel IV over 60 minutes on days 1 and 22 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 22 of cycle 1 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline, every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5.

ARM II: Patients receive pertuzumab, trastuzumab, and paclitaxel or docetaxel as in Arm I. Patients also receive placebo IV 30-60 minutes on day 22 of cycle 1 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline, every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5.

After completion of study treatment, patients are followed up at 30 days and every 3 months for 3 years and then every 6 months for 5 years.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • BCCA-Vancouver Island Cancer Centre
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System-Brampton Civic Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Sault Ste Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program Sault Area Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CSSS Champlain-Charles Le Moyne
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Katmai Oncology Group
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Goodyear, Arizona, United States, 85338
        • CTCA at Western Regional Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner-University Medical Center Phoenix
      • Sun City, Arizona, United States, 85351
        • Banner Boswell Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente-Anaheim
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Baldwin Park, California, United States, 91706
        • Kaiser Permanente-Baldwin Park
      • Bellflower, California, United States, 90706
        • Kaiser Permanente-Bellflower
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Costa Mesa, California, United States, 92627
        • UC Irvine Health Cancer Center-Newport
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Dublin, California, United States, 94568
        • Kaiser Permanente Dublin
      • Fontana, California, United States, 92335
        • Kaiser Permanente-Fontana
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fremont, California, United States, 94538
        • Washington Hospital
      • Fremont, California, United States, 94538
        • Palo Alto Medical Foundation-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • Harbor City, California, United States, 90710
        • Kaiser Permanente - Harbor City
      • Irvine, California, United States, 92618
        • Kaiser Permanente-Irvine
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90034
        • Kaiser Permanente West Los Angeles
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Ontario, California, United States, 91761
        • Kaiser Permanente-Ontario
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • Saint Joseph Hospital - Orange
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Panorama City, California, United States, 91402
        • Kaiser Permanente - Panorama City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • San Diego, California, United States, 92120
        • Kaiser Permanente-San Diego Zion
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Marcos, California, United States, 92078
        • Kaiser Permanente-San Marcos
      • San Rafael, California, United States, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Cruz, California, United States, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South Pasadena, California, United States, 91030
        • City of Hope South Pasadena
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Torrance, California, United States, 90503
        • City of Hope South Bay
      • Truckee, California, United States, 96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
      • Upland, California, United States, 91786
        • City of Hope Upland
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Vallejo, California, United States, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Woodland Hills, California, United States, 91367
        • Kaiser Permanente-Woodland Hills
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, United States, 80045
        • UCHealth University of Colorado Hospital
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, United States, 80920
        • Memorial Hospital North
      • Denver, Colorado, United States, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80204
        • Cancer Center of Colorado at Sloan's Lake
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Cancer Care and Hematology-Fort Collins
      • Greeley, Colorado, United States, 80631
        • UCHealth Greeley Hospital
      • Highlands Ranch, Colorado, United States, 80129
        • UCHealth Highlands Ranch Hospital
      • Lafayette, Colorado, United States, 80026
        • Good Samaritan Medical Center
      • Littleton, Colorado, United States, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Derby, Connecticut, United States, 06418
        • Smilow Cancer Hospital-Derby Care Center
      • Fairfield, Connecticut, United States, 06824
        • Smilow Cancer Hospital Care Center-Fairfield
      • Greenwich, Connecticut, United States, 06830
        • Smilow Cancer Hospital Care Center at Greenwich
      • Guilford, Connecticut, United States, 06437
        • Smilow Cancer Hospital Care Center - Guilford
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • North Haven, Connecticut, United States, 06473
        • Yale-New Haven Hospital North Haven Medical Center
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Orange, Connecticut, United States, 06477
        • Smilow Cancer Hospital-Orange Care Center
      • Torrington, Connecticut, United States, 06790
        • Smilow Cancer Hospital-Torrington Care Center
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterbury, Connecticut, United States, 06708
        • Smilow Cancer Hospital-Waterbury Care Center
      • Waterford, Connecticut, United States, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
        • Kaiser Permanente-Capitol Hill Medical Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Altamonte
      • Aventura, Florida, United States, 33180
        • GenesisCare USA - Aventura FP
      • Boca Raton, Florida, United States, 33431
        • GenesisCare USA - Boca Ration FP06
      • Celebration, Florida, United States, 34747
        • AdventHealth Celebration
      • Coral Gables, Florida, United States, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, United States, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
      • Plantation, Florida, United States, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
      • Weston, Florida, United States, 33331
        • Cleveland Clinic-Weston
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Memorial Hospital
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center LLC
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Augusta, Georgia, United States, 30901
        • Augusta Oncology Associates PC-D'Antignac
      • Augusta, Georgia, United States, 30909
        • Augusta Oncology Associates PC-Wheeler
      • Duluth, Georgia, United States, 30096
        • Northside Hospital - Duluth
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Fayette Hospital
      • Fort Gordon, Georgia, United States, 30905-5650
        • Eisenhower Army Medical Center
      • Lawrenceville, Georgia, United States, 30046
        • Northside Hospital - Gwinnett
      • Newnan, Georgia, United States, 30265
        • Piedmont Newnan Hospital
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Snellville, Georgia, United States, 30078
        • Suburban Hematology Oncology Associates - Snellville
      • Stockbridge, Georgia, United States, 30281
        • Piedmont Henry Hospital
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Westridge
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Cancer Institute - Nampa
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Cancer Clinic
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612
        • University Of Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Crystal Lake, Illinois, United States, 60014
        • AMG Crystal Lake - Oncology
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Elmhurst, Illinois, United States, 60126
        • Elmhurst Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Hazel Crest, Illinois, United States, 60429
        • Advocate South Suburban Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Joliet, Illinois, United States, 60435
        • Duly Health and Care Joliet
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, United States, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Libertyville, Illinois, United States, 60048
        • Condell Memorial Hospital
      • Libertyville, Illinois, United States, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Naperville, Illinois, United States, 60540
        • Edward Hospital/Cancer Center
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • Oak Lawn, Illinois, United States, 60453-2699
        • Advocate Christ Medical Center
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Plainfield, Illinois, United States, 60585
        • Edward Hospital/Cancer Center?Plainfield
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Rockford, Illinois, United States, 61114
        • SwedishAmerican Regional Cancer Center/ACT
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Northwest Cancer Center - Main Campus
      • Dyer, Indiana, United States, 46311
        • Northwest Oncology LLC
      • Hobart, Indiana, United States, 46342
        • Northwest Cancer Center - Hobart
      • Hobart, Indiana, United States, 46342
        • Saint Mary Medical Center
      • Indianapolis, Indiana, United States, 46312
        • Saint Catherine Hospital
      • Munster, Indiana, United States, 46321
        • The Community Hospital
      • Munster, Indiana, United States, 46321
        • Women's Diagnostic Center - Munster
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • Valparaiso, Indiana, United States, 46383
        • Northwest Cancer Center - Valparaiso
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Bettendorf, Iowa, United States, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Boone, Iowa, United States, 50036
        • McFarland Clinic - Boone
      • Carroll, Iowa, United States, 51401
        • Saint Anthony Regional Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mission Cancer and Blood - Laurel
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Fort Dodge, Iowa, United States, 50501
        • Trinity Regional Medical Center
      • Fort Dodge, Iowa, United States, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, United States, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • McFarland Clinic - Marshalltown
    • Kansas
      • Hays, Kansas, United States, 67601
        • HaysMed University of Kansas Health System
      • Kansas City, Kansas, United States, 66112
        • University of Kansas Cancer Center-West
      • Olathe, Kansas, United States, 66061
        • Olathe Health Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Healthcare Edgewood
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40207
        • Baptist Health Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • LSU Health Baton Rouge-North Clinic
      • Baton Rouge, Louisiana, United States, 70809
        • Louisiana Hematology Oncology Associates LLC
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70809
        • Our Lady of the Lake Physicians Group - Medical Oncology
      • Baton Rouge, Louisiana, United States, 70817
        • Woman's Hospital
      • Baton Rouge, Louisiana, United States, 70817
        • Our Lady of the Lake Medical Oncology
      • Covington, Louisiana, United States, 70433
        • Northshore Oncology Associates-Covington
      • Houma, Louisiana, United States, 70360
        • Oncology Center of The South Incorporated
    • Maine
      • Augusta, Maine, United States, 04330
        • Harold Alfond Center for Cancer Care
      • Belfast, Maine, United States, 04915
        • Waldo County General Hospital
      • Biddeford, Maine, United States, 04005
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center
      • Sanford, Maine, United States, 04073
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
      • South Portland, Maine, United States, 04106
        • Maine Medical Partners - South Portland
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Hospital
      • Baltimore, Maryland, United States, 21244
        • Kaiser Permanente-Woodlawn Medical Center
      • Bel Air, Maryland, United States, 21014
        • UM Upper Chesapeake Medical Center
      • Easton, Maryland, United States, 21601
        • University of Maryland Shore Medical Center at Easton
      • Frederick, Maryland, United States, 21702
        • FMH James M Stockman Cancer Institute
      • Gaithersburg, Maryland, United States, 20879
        • Kaiser Permanente-Gaithersburg Medical Center
      • Kensington, Maryland, United States, 20895
        • Kaiser Permanente - Kensington Medical Center
      • Largo, Maryland, United States, 20774
        • Kaiser Permanente - Largo Medical Center
      • Towson, Maryland, United States, 21204
        • UM Saint Joseph Medical Center
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Beverly Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
      • Gloucester, Massachusetts, United States, 01930
        • Addison Gilbert Hospital
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Bay City, Michigan, United States, 48706
        • McLaren Cancer Institute-Bay City
      • Brighton, Michigan, United States, 48114
        • Saint Joseph Mercy Brighton
      • Brighton, Michigan, United States, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Canton, Michigan, United States, 48188
        • Saint Joseph Mercy Canton
      • Canton, Michigan, United States, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Caro, Michigan, United States, 48723
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
        • Saint Joseph Mercy Chelsea
      • Chelsea, Michigan, United States, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Clarkston, Michigan, United States, 48346
        • McLaren Cancer Institute-Clarkston
      • Clarkston, Michigan, United States, 48346
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, United States, 48346
        • Newland Medical Associates-Clarkston
      • Clinton Township, Michigan, United States, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48236
        • Ascension Saint John Hospital
      • East China Township, Michigan, United States, 48054
        • Great Lakes Cancer Management Specialists-Doctors Park
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Farmington Hills, Michigan, United States, 48336
        • Beaumont Hospital - Farmington Hills
      • Flint, Michigan, United States, 48532
        • McLaren Cancer Institute-Flint
      • Flint, Michigan, United States, 48532
        • Singh and Arora Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Genesee Cancer and Blood Disease Treatment Center
      • Flint, Michigan, United States, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Academic Hematology Oncology Specialists
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Michigan Breast Specialists-Grosse Pointe Woods
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Lansing, Michigan, United States, 48912
        • Mid-Michigan Physicians-Lansing
      • Lansing, Michigan, United States, 48910
        • Karmanos Cancer Institute at McLaren Greater Lansing
      • Lapeer, Michigan, United States, 48446
        • McLaren Cancer Institute-Lapeer Region
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Livonia, Michigan, United States, 48154
        • Hope Cancer Clinic
      • Macomb, Michigan, United States, 48044
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
      • Macomb, Michigan, United States, 48044
        • Michigan Breast Specialists-Macomb Township
      • Marlette, Michigan, United States, 48453
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Cancer Institute-Macomb
      • Mount Pleasant, Michigan, United States, 48858
        • McLaren Cancer Institute-Central Michigan
      • Novi, Michigan, United States, 48374
        • Ascension Providence Hospitals - Novi
      • Petoskey, Michigan, United States, 49770
        • McLaren Cancer Institute-Northern Michigan
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Pontiac, Michigan, United States, 48341
        • Newland Medical Associates-Pontiac
      • Port Huron, Michigan, United States, 48060
        • McLaren-Port Huron
      • Rochester Hills, Michigan, United States, 48309
        • Great Lakes Cancer Management Specialists-Rochester Hills
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Ascension Saint Mary's Hospital
      • Saginaw, Michigan, United States, 48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Hospitals - Southfield
      • Sterling Heights, Michigan, United States, 48312
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, United States, 48764
        • Ascension Saint Joseph Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
      • Warren, Michigan, United States, 48093
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
      • Warren, Michigan, United States, 48093
        • Michigan Breast Specialists-Warren
      • West Branch, Michigan, United States, 48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, United States, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Deer River, Minnesota, United States, 56636
        • Essentia Health - Deer River Clinic
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Sandstone, Minnesota, United States, 55072
        • Essentia Health Sandstone
      • Thief River Falls, Minnesota, United States, 56701
        • Sanford Thief River Falls Medical Center
      • Virginia, Minnesota, United States, 55792
        • Essentia Health Virginia Clinic
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Gulfport, Mississippi, United States, 39502
        • Gulfport Memorial Hospital
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Bonne Terre, Missouri, United States, 63628
        • Parkland Health Center-Bonne Terre
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Columbia, Missouri, United States, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, United States, 65109
        • Capital Region Southwest Campus
      • Joplin, Missouri, United States, 64804
        • Freeman Health System
      • Kansas City, Missouri, United States, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Centers
      • Lee's Summit, Missouri, United States, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • North Kansas City, Missouri, United States, 64116
        • University of Kansas Cancer Center at North Kansas City Hospital
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • Saint Louis, Missouri, United States, 63136
        • Siteman Cancer Center at Christian Hospital
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • BJC Outpatient Center at Sunset Hills
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
      • Lincoln, Nebraska, United States, 68516
        • Southeast Nebraska Cancer Center - 68th Street Place
      • Lincoln, Nebraska, United States, 68516
        • Cancer Partners of Nebraska - Pine Lake
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68124
        • Alegent Health Bergan Mercy Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, United States, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • OptumCare Cancer Care at Fort Apache
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Exeter, New Hampshire, United States, 03833
        • Exeter Hospital
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Manchester, New Hampshire, United States, 03103
        • Solinsky Center for Cancer Care
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital-Luckow Pavilion
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
      • Ridgewood, New Jersey, United States, 07450
        • Neurosurgeons of New Jersey-Ridgewood
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
      • Voorhees, New Jersey, United States, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
      • Wayne, New Jersey, United States, 07470
        • Valley Medical Group - Wayne Multispecialty Practice
      • Westwood, New Jersey, United States, 07675
        • Valley Health System-Hematology/Oncology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants
      • Albuquerque, New Mexico, United States, 87110
        • Presbyterian Kaseman Hospital
      • Las Cruces, New Mexico, United States, 88011
        • Memorial Medical Center - Las Cruces
      • Rio Rancho, New Mexico, United States, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
    • New York
      • Auburn, New York, United States, 13021
        • Hematology Oncology Associates of Central New York-Auburn
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Campus
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10003
        • Mount Sinai Union Square
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, United States, 13215
        • Hematology Oncology Associates of Central New York-Onondaga Hill
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
      • West Islip, New York, United States, 11795
        • Good Samaritan University Hospital
    • North Carolina
      • Albemarle, North Carolina, United States, 28002
        • Atrium Health Stanly/LCI-Albemarle
      • Asheboro, North Carolina, United States, 27203
        • Randolph Hospital
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Asheville, North Carolina, United States, 28816
        • Hope Women's Cancer Centers-Asheville
      • Asheville, North Carolina, United States, 28806
        • Messino Cancer Centers
      • Asheville, North Carolina, United States, 28803
        • AdventHealth Infusion Center Asheville
      • Burlington, North Carolina, United States, 27215
        • Cone Health Cancer Center at Alamance Regional
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28210
        • Atrium Health Pineville/LCI-Pineville
      • Clinton, North Carolina, United States, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Clyde, North Carolina, United States, 28721
        • AdventHealth Infusion Center Haywood
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • Gastonia, North Carolina, United States, 28054
        • Levine Cancer Institute-Gaston
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Greensboro, North Carolina, United States, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
      • Hendersonville, North Carolina, United States, 28792
        • AdventHealth Hendersonville
      • Jacksonville, North Carolina, United States, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Kenansville, North Carolina, United States, 28349
        • Vidant Oncology-Kenansville
      • Kinston, North Carolina, United States, 28501
        • Vidant Oncology-Kinston
      • Lincolnton, North Carolina, United States, 28092
        • Atrium Health Lincoln/LCI-Lincolnton
      • Mebane, North Carolina, United States, 27302
        • Cone Heath Cancer Center at Mebane
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Richlands, North Carolina, United States, 28574
        • Vidant Oncology-Richlands
      • Rocky Mount, North Carolina, United States, 27804
        • Nash General Hospital
      • Washington, North Carolina, United States, 27889
        • Marion L Shepard Cancer Center at Vidant Beaufort Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System - Akron Campus
      • Barberton, Ohio, United States, 44203
        • Summa Health System - Barberton Campus
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Canton, Ohio, United States, 44708
        • Cleveland Clinic Mercy Hospital
      • Chardon, Ohio, United States, 44024
        • Geauga Hospital
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, United States, 45415
        • Dayton Physician LLC-Miami Valley Hospital North
      • Delaware, Ohio, United States, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Mansfield, Ohio, United States, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Mansfield, Ohio, United States, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, United States, 43302
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Medina, Ohio, United States, 44256
        • Summa Health Medina Medical Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Middleburg Heights, Ohio, United States, 44130
        • UH Seidman Cancer Center at Southwest General Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Parma, Ohio, United States, 44129
        • University Hospitals Parma Medical Center
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Ravenna, Ohio, United States, 44266
        • University Hospitals Portage Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, United States, 44870
        • UH Seidman Cancer Center at Firelands Regional Medical Center
      • Strongsville, Ohio, United States, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Wadsworth, Ohio, United States, 44281
        • University Hospitals Sharon Health Center
      • Warrensville Heights, Ohio, United States, 44122
        • South Pointe Hospital
      • West Chester, Ohio, United States, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, United States, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
      • Westlake, Ohio, United States, 44145
        • UHHS-Westlake Medical Center
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City
      • Oklahoma City, Oklahoma, United States, 73109
        • Integris Southwest Medical Center
      • Oklahoma City, Oklahoma, United States, 73142
        • Integris Cancer Institute of Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
      • Tulsa, Oklahoma, United States, 74133
        • Cancer Treatment Centers of America
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, United States, 97914
        • Saint Alphonsus Medical Center-Ontario
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Broomall, Pennsylvania, United States, 19008
        • Crozer-Keystone Regional Cancer Center at Broomall
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Collegeville, Pennsylvania, United States, 19426
        • Main Line Health Center-Collegeville
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Drexel Hill, Pennsylvania, United States, 19026
        • Delaware County Memorial Hospital
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Hospital
      • Exton, Pennsylvania, United States, 19341
        • Main Line Health Center-Exton
      • Glen Mills, Pennsylvania, United States, 19342
        • Crozer Regional Cancer Center at Brinton Lake
      • Greensburg, Pennsylvania, United States, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Harrisburg, Pennsylvania, United States, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Jefferson Hospital
      • Johnstown, Pennsylvania, United States, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster General Ann B Barshinger Cancer Institute
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Meadowbrook, Pennsylvania, United States, 19046
        • Holy Redeemer Hospital and Medical Center
      • Media, Pennsylvania, United States, 19063
        • Riddle Memorial Hospital
      • Monroeville, Pennsylvania, United States, 15146
        • Forbes Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC-Passavant Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • Scranton, Pennsylvania, United States, 18510
        • Community Medical Center
      • Upland, Pennsylvania, United States, 19013
        • Crozer-Chester Medical Center
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, United States, 15090
        • Wexford Health and Wellness Pavilion
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Williamsport, Pennsylvania, United States, 17701
        • UPMC Susquehanna
      • Willow Grove, Pennsylvania, United States, 19090
        • Asplundh Cancer Pavilion
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, United States, 17408
        • UPMC Memorial
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Saint Joseph's/Candler - Bluffton Campus
      • Boiling Springs, South Carolina, United States, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Easley, South Carolina, United States, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Hilton Head Island, South Carolina, United States, 29926-3827
        • South Carolina Cancer Specialists PC
      • Rock Hill, South Carolina, United States, 29732
        • Levine Cancer Institute-Rock Hill
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Avera Cancer Institute-Aberdeen
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Cookeville, Tennessee, United States, 38501
        • Cookeville Regional Medical Center
      • Kingsport, Tennessee, United States, 37660
        • Ballad Health Cancer Care - Kingsport
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Knoxville, Tennessee, United States, 37932
        • Thompson Cancer Survival Center - West
      • Lenoir City, Tennessee, United States, 37772
        • Thompson Oncology Group-Lenoir City
      • Maryville, Tennessee, United States, 37804
        • Thompson Oncology Group-Maryville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Oak Ridge, Tennessee, United States, 37830
        • Thompson Oncology Group-Oak Ridge
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Laredo, Texas, United States, 78041
        • Doctor's Hospital of Laredo
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Wellmont Medical Associates-Bristol
      • Burke, Virginia, United States, 22015
        • Kaiser Permanente-Burke Medical Center
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • McLean, Virginia, United States, 22102
        • Kaiser Permanente Tysons Corner Medical Center
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, United States, 23114
        • Bon Secours Saint Francis Medical Center
      • Norton, Virginia, United States, 24273
        • Southwest VA Regional Cancer Center
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Richmond, Virginia, United States, 23229
        • Virginia Cancer Institute
      • Richmond, Virginia, United States, 23226
        • Bon Secours Saint Mary's Hospital
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology PC
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Gig Harbor, Washington, United States, 98335
        • MultiCare Gig Harbor Medical Park
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-First Hill
      • Spokane, Washington, United States, 99204
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
      • Spokane, Washington, United States, 99218
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
      • Spokane Valley, Washington, United States, 99216
        • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • United Hospital Center
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Charleston Division
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, United States, 26101
        • Camden Clark Medical Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Ashland, Wisconsin, United States, 54806
        • Duluth Clinic Ashland
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • Mayo Clinic Health System-Eau Claire Clinic
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Janesville, Wisconsin, United States, 53548
        • Mercyhealth Hospital and Cancer Center - Janesville
      • Johnson Creek, Wisconsin, United States, 53038
        • UW Cancer Center Johnson Creek
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic Health System-Franciscan Healthcare
      • Madison, Wisconsin, United States, 53717
        • Dean Hematology and Oncology Clinic
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, United States, 54143
        • Saint Vincent Hospital Cancer Center at Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Medford, Wisconsin, United States, 54451
        • Aspirus Medford Hospital
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • Neenah, Wisconsin, United States, 54956
        • ThedaCare Regional Medical Center - Neenah
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, United States, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus Cancer Care - Wisconsin Rapids

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • The trial is open to female and male patients
  • Patients must be >= 18 years old
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease outside the central nervous system (CNS) confirmed as described below; eligible patients include those with either:

    • De novo metastatic disease presenting without prior history of HER2-positive breast cancer:

      • Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient
    • Locally recurrent or metastatic disease following prior therapy for early breast cancer:

      • Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease
      • There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
  • Patients must have measurable disease based on RECIST 1.1, as determined by the site, which has not been irradiated to be eligible
  • Patients with brain metastases are eligible if they meet ALL the following criteria:

    • Four or fewer metastatic sites to CNS
    • Largest unexcised tumor does not exceed 3 cm
    • No metastases to brain stem, midbrain, pons, medulla or the optic nerves and chiasm
    • Must have measurable disease outside the CNS, based on RECIST 1.1, as determined by the site, which has not been irradiated
    • If patient presented with symptoms from CNS metastases, the symptoms must have resolved with initiation of steroids and initial local therapy (surgery, radiation therapy, or both)
    • Must have been evaluated by Medical Oncologist and plan is to administer trastuzumab, pertuzumab, and a taxane as first-line systemic therapy
    • May have received administration of trastuzumab OR lapatinib concurrently with radiation therapy for brain metastases. Toxicities related to lapatinib if administered, should be =< grade 1 per the CTCAE v5.0, and the lapatinib must have been completed at least 2 weeks prior to study entry
    • No history of intracranial hemorrhage or spinal cord hemorrhage
    • No neurosurgical resection or brain biopsy within 10 days prior to study entry
  • After study entry and before randomization, send tissue for central HER2 confirmation; a tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on local testing according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Wolff 2018); HER2 status should initially be assessed using an Food and Drug Administration (FDA)-cleared IHC assay; positive is defined as IHC 3+ staining intensity; if HER2 IHC results are equivocal (2+), then HER2 status will be determined using a FDA-cleared HER2 in situ hybridization (ISH) test according to ASCO/CAP guidelines; Note: Once HER2-positive is confirmed on central testing, patients will be randomized to atezolizumab/placebo; randomization within 14 days from study entry will ensure that the Pharmaceutical Management Branch (PMB)-supplied agents will be received at the site for treatment on day 22 of cycle 1
  • The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status; patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant
  • The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline recommendations for hormone receptor testing; patients with < 1% ER and PgR staining by IHC will be classified as negative; if enough material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility
  • Localized palliative radiation therapy to sites of non-measurable disease is allowed for symptom management and may begin prior to study entry and continue following study entry while receiving study therapy
  • Patients must have imaging of the chest/abdomen/pelvis, preferably with a CT scan, and a bone scan within 5 weeks prior to study entry; (NOTE: if a patient is unable to receive CT contrast, a MRI of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative)
  • MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients
  • Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 14 days prior to study entry)
  • Platelet count must be >= 100,000/mm^3 (within 14 days prior to study entry)
  • Hemoglobin must be >= 8 g/dL (within 14 days prior to study entry)
  • Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN (within 14 days prior to study entry)
  • Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases (within 14 days prior to study entry)
  • Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 14 days prior to study entry)
  • Patients not receiving anti-coagulant therapy must have prothrombin time (PT) and international normalized ratio (INR) =< 1.5 x ULN within 14 days prior to study entry; for laboratories that do not report an ULN for the INR assay, use =< 1.5 as the value for the ULN; patients receiving anti-coagulants should have a baseline INR assessed, but the value does not affect eligibility
  • A serum thyroid-stimulating hormone (TSH) and AM (preferably in morning) cortisol must be obtained within 14 days prior to study entry to obtain a baseline value; patients with abnormal TSH or AM cortisol baseline levels should be further evaluated and managed per institutional standards; asymptomatic patients who require initiation or adjustment of medication or are followed without initiating treatment based on endocrinologist's recommendations are eligible
  • Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to study entry; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal
  • Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab/placebo and 7 months after the last dose of trastuzumab and pertuzumab; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of study entry are eligible for this trial

Exclusion Criteria:

  • Patients with brain metastases are excluded if they meet ANY of the following criteria:

    • Symptoms from brain metastases have not resolved prior to study entry
    • Five or more clearly identified foci of metastases to the brain
    • Largest unexcised tumor exceeds 3 cm
    • Spinal cord metastases
    • Medical Oncologist plans to employ HER2-directed tyrosine kinase inhibitor as component of systemic therapy
    • Metastatic disease limited to CNS
  • Leptomeningeal carcinomatosis
  • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) except as described in inclusion criteria
  • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
  • Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
  • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • 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
  • Uncontrolled hypertension defined as sustained systolic blood pressure (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)
  • History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy even if the current LVEF is >= 50%
  • 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 current 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

      • Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
      • History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or
      • Documented cardiomyopathy
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v 5.0
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to pertuzumab or trastuzumab or to any of its excipients, as well as any chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant antibodies
  • Known allergy or hypersensitivity to the components of the atezolizumab formulation or to any of the study drugs or excipients, (e.g., Cremophor EL, polysorbate 80)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis

    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:

      • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
      • Rash must cover less than 10% of body surface area (BSA)
      • Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
      • No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • Treatment with systemic immunomodulatory medications (including but not limited to interferons, IL-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to study entry
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis [anti-TNF] factor agents) within 14 days prior to study entry or anticipation of need for systemic immunosuppressive medications during the study; Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to study entry
  • Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV deoxyribonucleic acid (DNA) viral load per local guidelines
  • Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV ribonucleic acid (RNA)
  • Patients with clinically active tuberculosis
  • Severe infection within 4 weeks prior to study entry, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Prior allogeneic stem cell or solid organ transplantation
  • Symptomatic peripheral ischemia
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or >= grade 1 pulmonary fibrosis, per the CTCAE v5.0, on screening chest CT scan
  • Administration of a live, attenuated vaccine within 4 weeks prior to study entry or anticipation that such vaccine will be required during the study

    • Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to study entry, during treatment or within 5 months following the last dose of atezolizumab/placebo
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
  • Pregnancy or lactation at the time of study entry or intention to become pregnant during the study; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 3 days prior to study entry)
  • Use of any investigational product within 4 weeks prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (pertuzumab, trastuzumab, taxane therapy, atezolizumab)
Patients receive pertuzumab IV over 30-60 minutes on days 1 and 22, trastuzumab IV over 30-90 minutes on days 1 and 22, and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 or docetaxel IV over 60 minutes on days 1 and 22. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 22 of cycle 1 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo a biopsy at baseline. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline, every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Given IV
Other Names:
  • Herceptin
  • ABP 980
  • ALT02
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • Herzuma
  • Ogivri
  • Ontruzant
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • SB3
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar ALT02
  • trastuzumab biosimilar EG12014
  • Trastuzumab Biosimilar HLX02
  • Trastuzumab Biosimilar PF-05280014
  • Trastuzumab Biosimilar SB3
  • Trastuzumab-dkst
  • Trastuzumab-dttb
  • Trastuzumab-pkrb
  • Trazimera
  • Kanjinti
  • Trastuzumab Biosimilar SIBP-01
  • Trastuzumab-anns
  • Trastuzumab-qyyp
  • Herclon
  • QL 1701
  • QL-1701
  • QL1701
  • Trastuzumab Biosimilar QL1701
  • CT-P06
  • CT-P6
  • Trastuzumab Biosimilar CT-P6
  • Biceltis
  • CANMab
  • Hertraz
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Given IV
Other Names:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate
  • RP 56976
Given IV
Other Names:
  • Perjeta
  • 2C4
  • 2C4 Antibody
  • EG1206A
  • HLX11
  • HS627
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Omnitarg
  • Pertuzumab Biosimilar EG1206A
  • Pertuzumab Biosimilar HLX11
  • Pertuzumab Biosimilar HS627
  • rhuMAb2C4
  • RO4368451
  • BCD-178
  • Pertuzumab Biosimilar BCD-178
  • Rhumab 2C4
  • Pertuzumab Biosimilar TQB2440
  • TQB 2440
  • TQB-2440
  • TQB2440
Given IV
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Undergo bone scan
Other Names:
  • Bone Scintigraphy
Active Comparator: Arm II (pertuzumab, trastuzumab, taxane therapy, placebo)
Patients receive pertuzumab, trastuzumab, and paclitaxel or docetaxel as in Arm I. Patients also receive placebo IV 30-60 minutes on day 1 of cycle 22 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients may undergo a biopsy at baseline. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Given IV
Other Names:
  • Herceptin
  • ABP 980
  • ALT02
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • Herzuma
  • Ogivri
  • Ontruzant
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • SB3
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar ALT02
  • trastuzumab biosimilar EG12014
  • Trastuzumab Biosimilar HLX02
  • Trastuzumab Biosimilar PF-05280014
  • Trastuzumab Biosimilar SB3
  • Trastuzumab-dkst
  • Trastuzumab-dttb
  • Trastuzumab-pkrb
  • Trazimera
  • Kanjinti
  • Trastuzumab Biosimilar SIBP-01
  • Trastuzumab-anns
  • Trastuzumab-qyyp
  • Herclon
  • QL 1701
  • QL-1701
  • QL1701
  • Trastuzumab Biosimilar QL1701
  • CT-P06
  • CT-P6
  • Trastuzumab Biosimilar CT-P6
  • Biceltis
  • CANMab
  • Hertraz
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Given IV
Other Names:
  • Taxotere
  • Docecad
  • RP56976
  • Taxotere Injection Concentrate
  • RP 56976
Given IV
Given IV
Other Names:
  • Perjeta
  • 2C4
  • 2C4 Antibody
  • EG1206A
  • HLX11
  • HS627
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Omnitarg
  • Pertuzumab Biosimilar EG1206A
  • Pertuzumab Biosimilar HLX11
  • Pertuzumab Biosimilar HS627
  • rhuMAb2C4
  • RO4368451
  • BCD-178
  • Pertuzumab Biosimilar BCD-178
  • Rhumab 2C4
  • Pertuzumab Biosimilar TQB2440
  • TQB 2440
  • TQB-2440
  • TQB2440
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Undergo bone scan
Other Names:
  • Bone Scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: The time from randomization to the first documented progressive disease every 6 months, assessed up to 8 years
Will be determined using the current Response Evaluation Criteria in Solid Tumors 1.1 criteria. Analysis will be based on the intent to treat population. The stratified log-rank test will be used to compare the progression free survival between the two treatment arms with the following stratification factors: prior neoadjuvant or adjuvant therapy with trastuzumab (no; yes), estrogen receptor status (positive; negative), disease sites (any visceral without brain metastasis; non-visceral only without brain metastasis; brain metastasis), and choice of taxane (paclitaxel; docetaxel). The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.
The time from randomization to the first documented progressive disease every 6 months, assessed up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: The time from randomization to death from any cause every 6 months, assessed up to 8 years
Analysis will be based on the intent to treat population. The stratification factors are the same as what are used in the stratified log-rank test for the primary analysis on progression free survival. The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.
The time from randomization to death from any cause every 6 months, assessed up to 8 years
Overall objective response
Time Frame: Every 6 months up to 8 years
Defined as complete response or partial response. Will be determined using Response Evaluation Criteria in Solid Tumors 1.1 criteria. The stratified Cochran-Mantel-Haenszel test will be used to compare the object response between the treatment arms.
Every 6 months up to 8 years
Frequency of adverse events, including late immune-related toxicities
Time Frame: Every 6 months up to 8 years
Will be categorized using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. Comparisons of the adverse events between the two treatment arms will be done by the Fisher's exact test.
Every 6 months up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Charles E Geyer, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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