Breast Cancer Clinical Trial

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

Summary

The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

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Full Description

An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who 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, and who have received at least one, and no more than three, lines of therapy overall in the metastatic setting. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
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:

Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

624

Study ID:

NCT02492711

Recruitment Status:

Active, not recruiting

Sponsor:

MacroGenics

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There are 164 Locations for this study

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Ironwood Cancer & Research Center
Chandler Arizona, 85224, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Western Regional Medical Center, Inc.
Goodyear Arizona, 85338, United States
East Valley Hematology And Oncology
Burbank California, 91505, United States
UCLA Hematology Oncology Santa Monica
Los Angeles California, 90095, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Kaiser Permenente Medical Center
Vallejo California, 94589, United States
Poudre Valley Health Care, Inc.
Fort Collins Colorado, 80528, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
Florida Cancer Specialists
Fort Myers Florida, 33916, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood Florida, 33021, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Florida Cancer Specialists
New Port Richey Florida, 34655, United States
Orlndo Health Cancer Center
Orlando Florida, 32806, United States
Hem-Onc Associates
Port Saint Lucie Florida, 34952, United States
Palm Beach Cancer Center
West Palm Beach Florida, 33401, United States
Piedmont Cancer Institute, P.C.
Atlanta Georgia, 30318, United States
Northwest Georgia Oncology Centers, PC
Marietta Georgia, 30060, United States
CTCA - Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu Hawaii, 96819, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
CTCA - Midwestern Regional Medical Center
Zion Illinois, 60099, United States
Indiana University Health Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
ARH Cancer Clinic
Hazard Kentucky, 41701, United States
St. Joseph's Hospital
Lexington Kentucky, 40504, United States
Touro Infirmary Hospital
New Orleans Louisiana, 70115, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Mercy Medical Center
Baltimore Maryland, 21202, United States
Tufts-NEMC Cancer Center
Boston Massachusetts, 02111, United States
Forrest General Hospital
Hattiesburg Mississippi, 39401, United States
Saint Luke's Cancer Specialists
Kansas City Missouri, 64111, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Dartmouth-Hitchcock - Norris C
Lebanon New Hampshire, 03756, United States
New Jersey Hematology Oncology Associates
Brick New Jersey, 08724, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Saint Barnabas Medical Center - The Cancer Center
Livingston New Jersey, 07039, United States
New Mexico Cancer Care Alliance (NMCCA)
Albuquerque New Mexico, 87106, United States
Queens Hospital Center
Jamaica New York, 11432, United States
ProHEALTH CARE Associates, LLP
Lake Success New York, 11042, United States
New York University Clinical Cancer Center
New York New York, 10016, United States
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem North Carolina, 27157, United States
Mercy Physicians Of Oklahoma
Oklahoma City Oklahoma, 73120, United States
Pinnacle Health Cancer Institute
Harrisburg Pennsylvania, 17109, United States
Monongahela Valley Hospital
Monongahela Pennsylvania, 15063, United States
CTCA - Eastern Regional Medical Center, Inc.
Philadelphia Pennsylvania, 19124, United States
Guthrie Medical Group, PC
Sayre Pennsylvania, 18840, United States
Tennessee Oncology, PLLC
Chattanooga Tennessee, 37404, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Austin Cancer Center
Austin Texas, 78758, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Swedish Cancer Institute/ Swedish Health Services
Seattle Washington, 98104, United States
University of Washington/ Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Cancer Care Northwest, PS
Spokane Washington, 99202, United States
Medizinische Universität Innsbruck
Innsbruck Tirol, 6020, Austria
UZ Antwerpen
Edegem Antwerpen, 2650, Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk Antwerpen, 2610, Belgium
Clinique Saint-Pierre Ottignies
Ottignies Brabant Wallon, 1340, Belgium
UZ Brussel - Campus Jette
Brussels Brussels Capital Region, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels Brussels Capital Region, 1200, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt Limburg, 3500, Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas Oost-Vlaanderen, 9100, Belgium
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
Brugge West-Vlaanderen, 8000, Belgium
AZ Groeninge - Campus Loofstraat
Kortrijk West-Vlaanderen, 8500, Belgium
AZ Damiaan
Oostende West-Vlaanderen, 8400, Belgium
Chc - Clinique Saint-Joseph
Liège , 4000, Belgium
Clinique Sainte Elisabeth
Namur , 5000, Belgium
Dr. Leon Richard Oncology Centre
Moncton New Brunswick, E1C 8, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
Masarykuv onkologicky ustav
Brno Brno-město, 656 5, Czechia
Fakultni nemocnice Olomouc
Olomouc , 779 0, Czechia
Fakultni nemocnice v Motole
Praha 5 , 150 0, Czechia
Aarhus Universitetshospital
Aarhus C Central Jutland, 8000, Denmark
Regionshospitalet Herning (Herning Centralsygehus)
Herning Central Jutland, 7400, Denmark
Vejle Sygehus
Vejle South Denmark, 7100, Denmark
Næstved Sygehus
Aarhus N Zeeland, 4700, Denmark
Tampere University Hospital
Tampere Etelä-Suomen Lääni, 33521, Finland
Helsinki University Central Hospital (HUCH) - Meilahden Sair
Helsinki Länsi-Suomen Lääni, 00029, Finland
Center de Lutte Contre le Cancer (CLCC)
Nice Alpes-Martitimes, 06189, France
Center de Lutte Contre le Cancer (CLCC)
Caen cedex 05 Calvados, 14076, France
Centre Georges-François Lecler
Dijon Côte-d'Or, 21079, France
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer
St Herblain Loire-Atlantique, 44805, France
Centre Jean Perrin
Clermont-Ferrand Puy-de-Dôme, 63011, France
Centre Léon Bérard
Lyon Cedex 08 Rhône-Alpes, 69373, France
Institut Curie
Paris ÃŽle-de-France, 75005, France
Institut Curie - Hôpital René Huguenin
Saint-Cloud ÃŽle-de-France, 92210, France
Universitaetsklinikum Tuebingen
Tuebingen Baden-Württemberg, 72076, Germany
Universitätsklinikum Erlangen
Erlangen Bayern, 91054, Germany
Praxis für Frauenheilkunde Anita
München Bayern, 81925, Germany
Marien Hospital Düsseldorf
Düsseldorf Nordhein-Westfalen, 40479, Germany
Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde
Essen Nordrhein-Westfalen, 45122, Germany
Marien Hospital
Witten Nordrhein-Westfalen, 58452, Germany
Medizinische Fakultät Carl Gustav Carus
Dresden Sachsen, 01307, Germany
Universtatsklinikum Heidelberg Nationales
Heidelberg , , Germany
Soroka Medical Center [Oncology]
Beersheba HaDarom, 84802, Israel
Meir Medical Center
Kfar Saba HaMerkaz, 44281, Israel
Rabin Medical Center - Beilinson Hospital
Petaẖ Tiqwa HaMerkaz, 49100, Israel
The Chaim Sheba Medical Center - Insititute of Oncology
Ramat Gan HaMerkaz, 52621, Israel
Kaplan Medical Center
Rehovot HaMerkaz, 76100, Israel
Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem
Jerusalem Yerushalayim, 91120, Israel
Clalit Health Services - Lin Medical Center
Haifa , 35152, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania Cantania, 95122, Italy
Irccs Irst
Meldola Forli, 47014, Italy
Istituto di Candiolo, IRCCS
Candiolo Torino, 10060, Italy
Azienda Ospedaliero Universitaria Senese Universita degli St
Siena Toscana, 53100, Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
Ancona , 60126, Italy
AO G.Rummo
Benevento , 82100, Italy
ASST Papa Giovanni XXIII - Oncologia-Bergamo
Bergamo , 24127, Italy
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
Cremona , 26100, Italy
Arcispedale S.Anna, AOU di Ferrara
Ferrara , 44124, Italy
E.O. Ospedali Galliera
Genova , 16128, Italy
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
Lecco , 23900, Italy
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milano , 20121, Italy
Istituto Europeo di Oncologia Via Ripamonti
Milano , 20141, Italy
AOU Policlinico di Modena
Modena , 41122, Italy
Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori
Napoli , 80131, Italy
AOU di Parma
Parma , 43126, Italy
IRCCS Policlinico San Matteo
Pavia , 27100, Italy
IRCSS Fodazione Salvatore Maugeri
Pavia , 27100, Italy
SO S.Chiara, AOU Pisana
Pisa , 56126, Italy
Nuovo ospedale di Prato
Prato , 59100, Italy
PU Campus Bio-medico di Roma
Roma , 00128, Italy
AO S.Andrea, Università degli Studi di Roma La Sapienza
Roma , 00189, Italy
Ospedale Belcolle Viterbo
Viterbo , 01100, Italy
Seoul National University Hospital
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Asan Medical Center
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Samsung Medical Center
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Maastricht University Medical Centre
Maastricht Limburg, 6229 , Netherlands
Haga Ziekenhuis, loc. Leyenburg
Haag Zuid-Holland, 2545 , Netherlands
MAGODENT Sp. z o.o.
Warszawa Mazowieckie, 04-12, Poland
Mazowiecki Szpital Onkologiczny
Wieliszew Mazowieckie, 05-13, Poland
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
Lublin , 20-09, Poland
Centro Clínico Champalimaud/Fundação Champalimaud
Lisbon Lisboa, 1400-, Portugal
H. Santa Maria - Centro Hospitalar Lisboa Norte
Lisboa , 1649-, Portugal
Instituto Português Oncologia Francisco Gentil do Porto
Porto , 4200-, Portugal
Fundacion de Investigacion de Diego
San Juan , 927, Puerto Rico
H.U.V. del Rocío
Sevilla Andalucía, 41013, Spain
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitari Parc Taulí
Sabadell Barcelona, 08208, Spain
Hospital del Mar
Barcelona Catalunya, 08003, Spain
H.C.U. Valencia
Valencia Comunidad, 46010, Spain
Hospital de Navarra
Pamplona Navarra, 31008, Spain
H.U. Sant Joan de Reus
Reus Tarragona, 43204, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08023, Spain
H. San Pedro de Alcántara
Cáceres , 10003, Spain
H.U. Arnau de Vilanova
Lleida , 25198, Spain
M.D. Anderson Cancer Center Madrid
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario Clínico San Carlos
Madrid , 28040, Spain
Fundación Instituto Valenciano de Oncología
Valencia , 46009, Spain
Hospital Universitari I Politecnic La Fe
Valencia , 46026, Spain
Hospital Ntra. Sra. de Sonsoles
Ávila , 5004, Spain
Guys and St Thomas Hospital
London City Of London, SE1 9, United Kingdom
Castle Hill Hospital (Hull)
Hull East Riding Of Yorkshire, HU16 , United Kingdom
Kent Oncology Centre, Maidstone Hospital
Maidstone Kent, ME16 , United Kingdom
Royal Preston Hospital
Fulwood Lancashire, PR2 9, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough , TS4 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

624

Study ID:

NCT02492711

Recruitment Status:

Active, not recruiting

Sponsor:


MacroGenics

How clear is this clinincal trial information?

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