Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
NCT ID: NCT02492711
Last Updated: 2025-03-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
624 participants
INTERVENTIONAL
2015-08-24
2022-06-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer
NCT05227131
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
NCT01120184
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
NCT02139358
MARGetuximab Or Trastuzumab (MARGOT)
NCT04425018
Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
NCT02252887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Margetuximab plus chemotherapy
Margetuximab 15 mg/kg every 21 days
Margetuximab
15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
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
Trastuzumab plus chemotherapy
Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days
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
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
Margetuximab Infusion Sub-study
Margetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2.
Margetuximab
15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Margetuximab
15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
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
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
* Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
* Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
* Life expectancy ≥ 12 weeks
* Acceptable laboratory parameters
* Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug.
Infusion sub-study prior therapy requirements: Same as above, except:
* Must have received 4 or more prior lines or therapy in the metastatic setting
* Must have received prior trastuzumab, pertuzumab, and T-DM1
Exclusion Criteria
* History of uncontrolled seizures within 6 months of randomization
* History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
* History of clinically significant cardiovascular disease
* Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
* Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MacroGenics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ironwood Cancer & Research Center
Chandler, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States
East Valley Hematology And Oncology
Burbank, California, United States
UCLA Hematology Oncology Santa Monica
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Kaiser Permenente Medical Center
Vallejo, California, United States
Poudre Valley Health Care, Inc.
Fort Collins, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Florida Cancer Specialists
New Port Richey, Florida, United States
Orlndo Health Cancer Center
Orlando, Florida, United States
Hem-Onc Associates
Port Saint Lucie, Florida, United States
Palm Beach Cancer Center
West Palm Beach, Florida, United States
Piedmont Cancer Institute, P.C.
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
CTCA - Southeastern Regional Medical Center
Newnan, Georgia, United States
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
CTCA - Midwestern Regional Medical Center
Zion, Illinois, United States
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States
ARH Cancer Clinic
Hazard, Kentucky, United States
St. Joseph's Hospital
Lexington, Kentucky, United States
Touro Infirmary Hospital
New Orleans, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
Mercy Medical Center
Baltimore, Maryland, United States
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States
Forrest General Hospital
Hattiesburg, Mississippi, United States
Saint Luke's Cancer Specialists
Kansas City, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Dartmouth-Hitchcock - Norris C
Lebanon, New Hampshire, United States
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center - The Cancer Center
Livingston, New Jersey, United States
New Mexico Cancer Care Alliance (NMCCA)
Albuquerque, New Mexico, United States
Queens Hospital Center
Jamaica, New York, United States
ProHEALTH CARE Associates, LLP
Lake Success, New York, United States
New York University Clinical Cancer Center
New York, New York, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, United States
Mercy Physicians Of Oklahoma
Oklahoma City, Oklahoma, United States
Pinnacle Health Cancer Institute
Harrisburg, Pennsylvania, United States
Monongahela Valley Hospital
Monongahela, Pennsylvania, United States
CTCA - Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Austin Cancer Center
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States
Swedish Cancer Institute/ Swedish Health Services
Seattle, Washington, United States
University of Washington/ Seattle Cancer Care Alliance
Seattle, Washington, United States
Cancer Care Northwest, PS
Spokane, Washington, United States
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
UZ Antwerpen
Edegem, Antwerpen, Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, Antwerpen, Belgium
Clinique Saint-Pierre Ottignies
Ottignies, Brabant Wallon, Belgium
UZ Brussel - Campus Jette
Brussels, Brussels Capital, Belgium
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Limburg, Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
Bruges, West-Vlaanderen, Belgium
AZ Groeninge - Campus Loofstraat
Kortrijk, West-Vlaanderen, Belgium
AZ Damiaan
Ostend, West-Vlaanderen, Belgium
Chc - Clinique Saint-Joseph
Liège, , Belgium
Clinique Sainte Elisabeth
Namur, , Belgium
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Masarykuv onkologicky ustav
Brno, Brno-město, Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Aarhus Universitetshospital
Aarhus C, Central Jutland, Denmark
Regionshospitalet Herning (Herning Centralsygehus)
Herning, Central Jutland, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Næstved Sygehus
Aarhus N, Zeeland, Denmark
Tampere University Hospital
Tampere, Etelä-Suomen Lääni, Finland
Helsinki University Central Hospital (HUCH) - Meilahden Sair
Helsinki, Länsi-Suomen Lääni, Finland
Center de Lutte Contre le Cancer (CLCC)
Nice, Alpes-Martitimes, France
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
Center de Lutte Contre le Cancer (CLCC)
Caen, Calvados, France
Centre Georges-François Lecler
Dijon, Côte-d'Or, France
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer
Saint-Herblain, Loire-Atlantique, France
Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, France
Institut Curie
Paris, Île-de-France Region, France
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France Region, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Praxis für Frauenheilkunde Anita
München, Bavaria, Germany
Marien Hospital Düsseldorf
Düsseldorf, Nordhein-Westfalen, Germany
Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde
Essen, North Rhine-Westphalia, Germany
Marien Hospital
Witten, North Rhine-Westphalia, Germany
Medizinische Fakultät Carl Gustav Carus
Dresden, Saxony, Germany
Universtatsklinikum Heidelberg Nationales
Heidelberg, , Germany
Meir Medical Center
Kfar Saba, Central District, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Central District, Israel
The Chaim Sheba Medical Center - Insititute of Oncology
Ramat Gan, Central District, Israel
Kaplan Medical Center
Rehovot, Central District, Israel
Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem
Jerusalem, Jerusalem, Israel
Soroka Medical Center [Oncology]
Beersheba, Southern District, Israel
Clalit Health Services - Lin Medical Center
Haifa, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania, Cantania, Italy
Irccs Irst
Meldola, Forli, Italy
Istituto di Candiolo, IRCCS
Candiolo, Torino, Italy
Azienda Ospedaliero Universitaria Senese Universita degli St
Siena, Tuscany, Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
Ancona, , Italy
AO G.Rummo
Benevento, , Italy
ASST Papa Giovanni XXIII - Oncologia-Bergamo
Bergamo, , Italy
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
Cremona, , Italy
Arcispedale S.Anna, AOU di Ferrara
Ferrara, , Italy
E.O. Ospedali Galliera
Genova, , Italy
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
Lecco, , Italy
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, , Italy
Istituto Europeo di Oncologia Via Ripamonti
Milan, , Italy
AOU Policlinico di Modena
Modena, , Italy
Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori
Napoli, , Italy
AOU di Parma
Parma, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
IRCSS Fodazione Salvatore Maugeri
Pavia, , Italy
SO S.Chiara, AOU Pisana
Pisa, , Italy
Nuovo ospedale di Prato
Prato, , Italy
PU Campus Bio-medico di Roma
Roma, , Italy
AO S.Andrea, Università degli Studi di Roma La Sapienza
Roma, , Italy
Ospedale Belcolle Viterbo
Viterbo, , Italy
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Haga Ziekenhuis, loc. Leyenburg
The Hague, South Holland, Netherlands
MAGODENT Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, Masovian Voivodeship, Poland
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Lublin, , Poland
Centro Clínico Champalimaud/Fundação Champalimaud
Lisbon, Lisbon District, Portugal
H. Santa Maria - Centro Hospitalar Lisboa Norte
Lisbon, , Portugal
Instituto Português Oncologia Francisco Gentil do Porto
Porto, , Portugal
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
H.U.V. del Rocío
Seville, Andalusia, Spain
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
H.C.U. Valencia
Valencia, Comunidad, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
H.U. Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Ntra. Sra. de Sonsoles
Ávila, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
H. San Pedro de Alcántara
Cáceres, , Spain
H.U. Arnau de Vilanova
Lleida, , Spain
M.D. Anderson Cancer Center Madrid
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Fundación Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Universitari I Politecnic La Fe
Valencia, , Spain
Guys and St Thomas Hospital
London, City of London, United Kingdom
Castle Hill Hospital (Hull)
Hull, East Riding Of Yorkshire, United Kingdom
Kent Oncology Centre, Maidstone Hospital
Maidstone, Kent, United Kingdom
Royal Preston Hospital
Fulwood, Lancashire, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rugo HS, Im SA, Cardoso F, Cortes J, Curigliano G, Musolino A, Pegram MD, Bachelot T, Wright GS, Saura C, Escriva-de-Romani S, De Laurentiis M, Schwartz GN, Pluard TJ, Ricci F, Gwin WR 3rd, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petrakova K, Yardley DA, Freedman O, Jakobsen EH, Gal-Yam EN, Yerushalmi R, Fasching PA, Kaufman PA, Ashley EJ, Perez-Olle R, Hong S, Rosales MK, Gradishar WJ; SOPHIA Study Group. Margetuximab Versus Trastuzumab in Patients With Previously Treated HER2-Positive Advanced Breast Cancer (SOPHIA): Final Overall Survival Results From a Randomized Phase 3 Trial. J Clin Oncol. 2023 Jan 10;41(2):198-205. doi: 10.1200/JCO.21.02937. Epub 2022 Nov 4.
Rugo HS, Im SA, Cardoso F, Cortes J, Curigliano G, Musolino A, Pegram MD, Wright GS, Saura C, Escriva-de-Romani S, De Laurentiis M, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petrakova K, Yardley DA, Freedman O, Jakobsen EH, Kaufman B, Yerushalmi R, Fasching PA, Nordstrom JL, Bonvini E, Koenig S, Edlich S, Hong S, Rock EP, Gradishar WJ; SOPHIA Study Group. Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):573-584. doi: 10.1001/jamaoncol.2020.7932.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP-MGAH22-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.