Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

624

Participants

Timeline

Start Date

August 24, 2015

Primary Completion Date

August 11, 2021

Study Completion Date

June 14, 2022

Conditions
HER-2 Positive Breast CancerMetastatic Neoplasm
Interventions
BIOLOGICAL

Margetuximab

15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,

BIOLOGICAL

Trastuzumab

8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion on day 1 of each 21 day cycle

DRUG

Physician's choice of chemotherapy.

Capecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle

Trial Locations (167)

927

Fundacion de Investigacion de Diego, San Juan

1090

UZ Brussel - Campus Jette, Brussels

1200

Cliniques universitaires Saint-Luc, Brussels

1340

Clinique Saint-Pierre Ottignies, Ottignies

2610

GZA Ziekenhuizen - Campus Sint-Augustinus, Wilrijk

2650

UZ Antwerpen, Edegem

3500

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

4000

Chc - Clinique Saint-Joseph, Liège

4700

Næstved Sygehus, Aarhus N

5000

Clinique Sainte Elisabeth, Namur

5004

Hospital Ntra. Sra. de Sonsoles, Ávila

6020

Medizinische Universität Innsbruck, Innsbruck

7100

Vejle Sygehus, Vejle

7400

Regionshospitalet Herning (Herning Centralsygehus), Herning

8000

AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan, Bruges

Aarhus Universitetshospital, Aarhus C

8400

AZ Damiaan, Ostend

8500

AZ Groeninge - Campus Loofstraat, Kortrijk

9100

AZ Nikolaas - Campus Sint-Niklaas Moerland, Sint-Niklaas

10003

H. San Pedro de Alcántara, Cáceres

10016

New York University Clinical Cancer Center, New York

10060

Istituto di Candiolo, IRCCS, Candiolo

11042

ProHEALTH CARE Associates, LLP, Lake Success

11432

Queens Hospital Center, Jamaica

14076

Center de Lutte Contre le Cancer (CLCC), Caen

15063

Monongahela Valley Hospital, Monongahela

16128

E.O. Ospedali Galliera, Genova

17109

Pinnacle Health Cancer Institute, Harrisburg

18840

Guthrie Medical Group, PC, Sayre

19124

CTCA - Eastern Regional Medical Center, Inc., Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

20121

Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milan

20141

Istituto Europeo di Oncologia Via Ripamonti, Milan

21079

Centre Georges-François Lecler, Dijon

21202

Mercy Medical Center, Baltimore

22031

Inova Schar Cancer Institute, Fairfax

22060

Fort Belvoir Community Hospital, Fort Belvoir

22908

University of Virginia Cancer Center, Charlottesville

23900

PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco, Lecco

24127

ASST Papa Giovanni XXIII - Oncologia-Bergamo, Bergamo

25198

H.U. Arnau de Vilanova, Lleida

26100

PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona, Cremona

27100

IRCCS Policlinico San Matteo, Pavia

IRCSS Fodazione Salvatore Maugeri, Pavia

27157

Wake Forest University Baptist Medical Center (WFUBMC), Winston-Salem

28033

M.D. Anderson Cancer Center Madrid, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Universitario Clínico San Carlos, Madrid

30060

Northwest Georgia Oncology Centers, PC, Marietta

30265

CTCA - Southeastern Regional Medical Center, Newnan

30318

Piedmont Cancer Institute, P.C., Atlanta

31008

Hospital de Navarra, Pamplona

32806

Orlndo Health Cancer Center, Orlando

33021

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33401

Palm Beach Cancer Center, West Palm Beach

33521

Tampere University Hospital, Tampere

33916

Florida Cancer Specialists, Fort Myers

34655

Florida Cancer Specialists, New Port Richey

34952

Hem-Onc Associates, Port Saint Lucie

35152

Clalit Health Services - Lin Medical Center, Haifa

37203

The Sarah Cannon Research Institute, Nashville

37404

Tennessee Oncology, PLLC, Chattanooga

39401

Forrest General Hospital, Hattiesburg

40479

Marien Hospital Düsseldorf, Düsseldorf

40504

St. Joseph's Hospital, Lexington

41013

H.U.V. del Rocío, Seville

41122

AOU Policlinico di Modena, Modena

41701

ARH Cancer Clinic, Hazard

43126

AOU di Parma, Parma

43204

H.U. Sant Joan de Reus, Reus

44124

Arcispedale S.Anna, AOU di Ferrara, Ferrara

44281

Meir Medical Center, Kfar Saba

44805

Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer, Saint-Herblain

45122

Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde, Essen

46009

Fundación Instituto Valenciano de Oncología, Valencia

46010

H.C.U. Valencia, Valencia

46026

Hospital Universitari I Politecnic La Fe, Valencia

46526

Indiana University Health Goshen Center for Cancer Care, Goshen

47014

Irccs Irst, Meldola

49100

Rabin Medical Center - Beilinson Hospital, Petah Tikva

52621

The Chaim Sheba Medical Center - Insititute of Oncology, Ramat Gan

53100

Azienda Ospedaliero Universitaria Senese Universita degli St, Siena

56126

SO S.Chiara, AOU Pisana, Pisa

58452

Marien Hospital, Witten

59100

Nuovo ospedale di Prato, Prato

60099

CTCA - Midwestern Regional Medical Center, Zion

60126

Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc, Ancona

60611

Northwestern University Feinberg School of Medicine, Chicago

60612

Rush University Medical Center, Chicago

61801

Carle Cancer Center, Urbana

63011

Centre Jean Perrin, Clermont-Ferrand

63141

Mercy Hospital Saint Louis, St Louis

64111

Saint Luke's Cancer Specialists, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

69373

Centre Léon Bérard, Lyon

70115

Touro Infirmary Hospital, New Orleans

72076

Universitaetsklinikum Tuebingen, Tübingen

73120

Mercy Physicians Of Oklahoma, Oklahoma City

75005

Institut Curie, Paris

75390

University of Texas Southwestern Medical Center, Dallas

76104

The Center for Cancer and Blood Disorders, Fort Worth

78758

Austin Cancer Center, Austin

80131

Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori, Napoli

80528

Poudre Valley Health Care, Inc., Fort Collins

81925

Praxis für Frauenheilkunde Anita, München

82100

AO G.Rummo, Benevento

84106

Utah Cancer Specialists, Salt Lake City

84802

Soroka Medical Center [Oncology], Beersheba

85224

Ironwood Cancer & Research Center, Chandler

85234

Banner MD Anderson Cancer Center, Gilbert

85338

Western Regional Medical Center, Inc., Goodyear

87106

New Mexico Cancer Care Alliance (NMCCA), Albuquerque

90095

UCLA Hematology Oncology Santa Monica, Los Angeles

91054

Universitätsklinikum Erlangen, Erlangen

91120

Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem, Jerusalem

91505

East Valley Hematology And Oncology, Burbank

92123

Sharp Memorial Hospital, San Diego

92210

Institut Curie - Hôpital René Huguenin, Saint-Cloud

94115

University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco

94589

Kaiser Permenente Medical Center, Vallejo

95122

PO Garibaldi-Nesima, ARNAS Garibaldi, Catania

95817

UC Davis Comprehensive Cancer Center, Sacramento

96819

Kaiser Permanente Hawaii Moanalua Medical Center, Honolulu

98104

Swedish Cancer Institute/ Swedish Health Services, Seattle

98109

University of Washington/ Seattle Cancer Care Alliance, Seattle

99202

Cancer Care Northwest, PS, Spokane

761001

Kaplan Medical Center, Rehovot

04074

New England Cancer Specialists, Scarborough

02111

Tufts-NEMC Cancer Center, Boston

03756

Dartmouth-Hitchcock - Norris C, Lebanon

08724

New Jersey Hematology Oncology Associates, Brick

07601

Hackensack University Medical Center, Hackensack

07039

Saint Barnabas Medical Center - The Cancer Center, Livingston

E1C 8X3

Dr. Leon Richard Oncology Centre, Moncton

L1G 2B9

Lakeridge Health Oshawa, Oshawa

656 53

Masarykuv onkologicky ustav, Brno

779 00

Fakultni nemocnice Olomouc, Olomouc

150 06

Fakultni nemocnice v Motole, Prague

00029

Helsinki University Central Hospital (HUCH) - Meilahden Sair, Helsinki

06189

Center de Lutte Contre le Cancer (CLCC), Nice

01307

Medizinische Fakultät Carl Gustav Carus, Dresden

Unknown

Universtatsklinikum Heidelberg Nationales, Heidelberg

00128

PU Campus Bio-medico di Roma, Roma

00189

AO S.Andrea, Università degli Studi di Roma La Sapienza, Roma

01100

Ospedale Belcolle Viterbo, Viterbo

6229 HX

Maastricht University Medical Centre, Maastricht

2545 CH

Haga Ziekenhuis, loc. Leyenburg, The Hague

04-125

MAGODENT Sp. z o.o., Warsaw

05-135

Mazowiecki Szpital Onkologiczny, Wieliszew

20-090

Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Lublin

1400-038

Centro Clínico Champalimaud/Fundação Champalimaud, Lisbon

1649-035

H. Santa Maria - Centro Hospitalar Lisboa Norte, Lisbon

4200-072

Instituto Português Oncologia Francisco Gentil do Porto, Porto

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08916

Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona

08208

Hospital Universitari Parc Taulí, Sabadell

08003

Hospital del Mar, Barcelona

08023

Hospital Universitario Vall d'Hebron, Barcelona

SE1 9RT

Guys and St Thomas Hospital, London

HU16 5JQ

Castle Hill Hospital (Hull), Hull

ME16 9QQ

Kent Oncology Centre, Maidstone Hospital, Maidstone

PR2 9HT

Royal Preston Hospital, Fulwood

TS4 3BW

South Tees Hospitals NHS Foundation Trust, Middlesbrough

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MacroGenics

INDUSTRY