Spots Global Cancer Trial Database for Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
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Trial Identification
Brief Title: Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
Official Title: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
Study ID: NCT02492711
Study Description
Brief Summary: The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Saint 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, Tirol, 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 Region, Belgium
Cliniques universitaires Saint-Luc, Brussels, Brussels Capital Region, 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, Brugge, West-Vlaanderen, Belgium
AZ Groeninge - Campus Loofstraat, Kortrijk, West-Vlaanderen, Belgium
AZ Damiaan, Oostende, 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, Praha 5, , Czechia
Aarhus Universitetshospital, Aarhus C, Central Jutland, Denmark
Regionshospitalet Herning (Herning Centralsygehus), Herning, Central Jutland, Denmark
Vejle Sygehus, Vejle, South Denmark, 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
Center de Lutte Contre le Cancer (CLCC), Caen cedex 05, Calvados, France
Centre Georges-François Lecler, Dijon, Côte-d'Or, France
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer, St Herblain, Loire-Atlantique, France
Centre Jean Perrin, Clermont-Ferrand, Puy-de-Dôme, France
Centre Léon Bérard, Lyon Cedex 08, Rhône-Alpes, France
Institut Curie, Paris, Île-de-France, France
Institut Curie - Hôpital René Huguenin, Saint-Cloud, Île-de-France, France
Universitaetsklinikum Tuebingen, Tuebingen, Baden-Württemberg, Germany
Universitätsklinikum Erlangen, Erlangen, Bayern, Germany
Praxis für Frauenheilkunde Anita, München, Bayern, Germany
Marien Hospital Düsseldorf, Düsseldorf, Nordhein-Westfalen, Germany
Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde, Essen, Nordrhein-Westfalen, Germany
Marien Hospital, Witten, Nordrhein-Westfalen, Germany
Medizinische Fakultät Carl Gustav Carus, Dresden, Sachsen, Germany
Universtatsklinikum Heidelberg Nationales, Heidelberg, , Germany
Soroka Medical Center [Oncology], Beersheba, HaDarom, Israel
Meir Medical Center, Kfar Saba, HaMerkaz, Israel
Rabin Medical Center - Beilinson Hospital, Petaẖ Tiqwa, HaMerkaz, Israel
The Chaim Sheba Medical Center - Insititute of Oncology, Ramat Gan, HaMerkaz, Israel
Kaplan Medical Center, Rehovot, HaMerkaz, Israel
Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem, Jerusalem, Yerushalayim, 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, Toscana, 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, Milano, , Italy
Istituto Europeo di Oncologia Via Ripamonti, Milano, , 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
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Maastricht University Medical Centre, Maastricht, Limburg, Netherlands
Haga Ziekenhuis, loc. Leyenburg, Haag, Zuid-Holland, Netherlands
MAGODENT Sp. z o.o., Warszawa, Mazowieckie, Poland
Mazowiecki Szpital Onkologiczny, Wieliszew, Mazowieckie, Poland
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Lublin, , Poland
Centro Clínico Champalimaud/Fundação Champalimaud, Lisbon, Lisboa, Portugal
H. Santa Maria - Centro Hospitalar Lisboa Norte, Lisboa, , Portugal
Instituto Português Oncologia Francisco Gentil do Porto, Porto, , Portugal
Fundacion de Investigacion de Diego, San Juan, , Puerto Rico
H.U.V. del Rocío, Sevilla, Andalucía, Spain
Institut Català d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitari Parc Taulí, Sabadell, Barcelona, Spain
Hospital del Mar, Barcelona, Catalunya, Spain
H.C.U. Valencia, Valencia, Comunidad, Spain
Hospital de Navarra, Pamplona, Navarra, Spain
H.U. Sant Joan de Reus, Reus, Tarragona, 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
Hospital Ntra. Sra. de Sonsoles, Ávila, , 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
Contact Details
Name: Stephen L Eck, M.D., Ph.D.
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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