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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02492711
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Brief 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.

Condition or disease Intervention/treatment Phase
HER-2 Positive Breast Cancer Metastatic Neoplasm Biological: Margetuximab Biological: Trastuzumab Drug: Capecitabine Drug: Eribulin Drug: Gemcitabine Drug: Vinorelbine Phase 3

Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Detailed 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 78 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 24, 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Margetuximab plus chemotherapy
Margetuximab 15 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle
Biological: Margetuximab
15 mg/kg via IV (intravenous) infusion over 120 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.

Drug: Capecitabine
1000 mg/m2 BID for 14 days in a 21-day cycle
Other Name: Xeloda®

Drug: Eribulin
1.4 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Halaven®

Drug: Gemcitabine
1000 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Gemzar ®

Drug: Vinorelbine
25-30 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Navelbine®

Active Comparator: Trastuzumab plus chemotherapy
Trastuzumab 8 mg/kg loading dose then 6 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 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 over 30-90 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.
Other Name: Herceptin®

Drug: Capecitabine
1000 mg/m2 BID for 14 days in a 21-day cycle
Other Name: Xeloda®

Drug: Eribulin
1.4 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Halaven®

Drug: Gemcitabine
1000 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Gemzar ®

Drug: Vinorelbine
25-30 mg/m2 on days 1 and 8 of a 21-day cycle
Other Name: Navelbine®




Primary Outcome Measures :
  1. Progression-free survival (PFS) as determined by independent radiological review. [ Time Frame: Approximately 41 months after the first subject is randomized; anticipated evaluation Dec 2018 ]
  2. Overall survival (OS) defined as the number of days from randomization to the date of death (from any cause). [ Time Frame: Approximately 15 months after the last subject is randomized; anticipated evaluation Mar 2020 ]
    Overall survival of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer.

  3. Infusion rate sub-study Grade 3 plus safety [ Time Frame: Cycle 2 (21 days) ]
    Incidence of Grade 3 or higher infusion-related reactions


Secondary Outcome Measures :
  1. To evaluate progression-free survival (PFS), as assessed by study investigators. [ Time Frame: PFS will be evaluated approximately 41 months after the first subject is randomized. ]
  2. To evaluate the objective response rate (ORR) as determined by independent radiological review. [ Time Frame: ORR will be evaluated approximately 41 months after the first subject is randomized. ]
  3. Infusion rate sub-study all safety [ Time Frame: Cycle 2 (21 days) ]
    Incidence of all grades of infusion-related reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492711


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Locations
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United States, Arizona
Ironwood Cancer & Research Center
Chandler, Arizona, United States, 85224
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
United States, California
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
East Valley Hematology And Oncology
Burbank, California, United States, 91505
UCLA Hematology Oncology Santa Monica
Los Angeles, California, United States, 90095
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sharp Memorial Hospital
San Diego, California, United States, 92123
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Kaiser Permenente Medical Center
Vallejo, California, United States, 94589
United States, Colorado
Poudre Valley Health Care, Inc.
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Florida Cancer Specialists
New Port Richey, Florida, United States, 34655
Orlndo Health Cancer Center
Orlando, Florida, United States, 32806
Hem-Onc Associates
Port Saint Lucie, Florida, United States, 34952
Palm Beach Cancer Center
West Palm Beach, Florida, United States, 33401
United States, Georgia
Piedmont Cancer Institute, P.C.
Atlanta, Georgia, United States, 30318
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
CTCA - Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Hawaii
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Hematology Oncology North Shore
Skokie, Illinois, United States, 60076
Presence Medical Group Hematology Oncology
Skokie, Illinois, United States, 60077
Carle Cancer Center
Urbana, Illinois, United States, 61801
CTCA - Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Indiana
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Iowa
Physicians Clinic of Iowa
Cedar Rapids, Iowa, United States, 52403
United States, Kentucky
ARH Cancer Clinic
Hazard, Kentucky, United States, 41701
St. Joseph's Hospital
Lexington, Kentucky, United States, 40504
United States, Louisiana
Touro Infirmary Hospital
New Orleans, Louisiana, United States, 70115
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
FRHS - James M. Stockman Cancer Institute
Frederick, Maryland, United States, 21701
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55404
United States, Mississippi
Forrest General Hospital
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Saint Luke's Cancer Specialists
Kansas City, Missouri, United States, 64111
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
United States, New Hampshire
Dartmouth-Hitchcock - Norris C
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States, 08724
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Barnabas Medical Center - The Cancer Center
Livingston, New Jersey, United States, 07039
United States, New Mexico
New Mexico Cancer Care Alliance (NMCCA)
Albuquerque, New Mexico, United States, 87106
United States, New York
Queens Hospital Center
Jamaica, New York, United States, 11432
ProHEALTH CARE Associates, LLP
Lake Success, New York, United States, 11042
New York University Clinical Cancer Center
New York, New York, United States, 10016
Weill Cornell Breast Center
New York, New York, United States, 10065
United States, North Carolina
ECU - Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Wake Forest University Baptist Medical Center (WFUBMC)
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Mercy Physicians Of Oklahoma
Oklahoma City, Oklahoma, United States, 73120
CTCA - Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Pinnacle Health Cancer Institute
Harrisburg, Pennsylvania, United States, 17109
Monongahela Valley Hospital
Monongahela, Pennsylvania, United States, 15063
CTCA - Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, United States, 19124
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States, 37404
Tennessee Cancer Specialists, PLLC - Dowell Springs
Knoxville, Tennessee, United States, 37920
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Austin Cancer Center
Austin, Texas, United States, 78758
St. Joseph Health Cancer Center
Bryan, Texas, United States, 77802
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
East Texas Medical Center Cancer Institute
Tyler, Texas, United States, 75701
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
United States, Washington
Swedish Cancer Institute/ Swedish Health Services
Seattle, Washington, United States, 98104
University of Washington/ Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Cancer Care Northwest, PS
Spokane, Washington, United States, 99202
Austria
Medizinische Universität Innsbruck
Innsbruck, Tirol, Austria, 6020
Belgium
UZ Antwerpen
Edegem, Antwerpen, Belgium, 2650
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, Antwerpen, Belgium, 2610
Clinique Saint-Pierre Ottignies
Ottignies, Brabant Wallon, Belgium, 1340
UZ Brussel - Campus Jette
Brussels, Brussels Capital Region, Belgium, 1090
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital Region, Belgium, 1200
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Limburg, Belgium, 3500
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
Brugge, West-Vlaanderen, Belgium, 8000
AZ Groeninge - Campus Loofstraat
Kortrijk, West-Vlaanderen, Belgium, 8500
AZ Damiaan
Oostende, West-Vlaanderen, Belgium, 8400
Chc - Clinique Saint-Joseph
Liège, Belgium, 4000
Clinique Sainte Elisabeth
Namur, Belgium, 5000
Canada, New Brunswick
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Czechia
Masarykuv onkologicky ustav
Brno, Brno-město, Czechia, 656 53
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Fakultni nemocnice v Motole
Praha 5, Czechia, 150 06
Denmark
Aarhus Universitetshospital
Aarhus C, Central Jutland, Denmark, 8000
Regionshospitalet Herning (Herning Centralsygehus)
Herning, Central Jutland, Denmark, 7400
Vejle Sygehus
Vejle, South Denmark, Denmark, 7100
Næstved Sygehus
Aarhus N, Zeeland, Denmark, 4700
Finland
Tampere University Hospital
Tampere, Etelä-Suomen Lääni, Finland, 33521
Helsinki University Central Hospital (HUCH) - Meilahden Sair
Helsinki, Länsi-Suomen Lääni, Finland, 00029
France
Center de Lutte Contre le Cancer (CLCC)
Nice, Alpes-Martitimes, France, 06189
Hôpital Privé Clairval
Marseille, Bouches-du-Rhône, France, 13009
Center de Lutte Contre le Cancer (CLCC)
Caen cedex 05, Calvados, France, 14076
Centre Georges-François Lecler
Dijon, Côte-d'Or, France, 21079
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer
St Herblain, Loire-Atlantique, France, 44805
Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, France, 63011
Centre Léon Bérard
Lyon Cedex 08, Rhône-Alpes, France, 69373
Institut Curie
Paris, Île-de-France, France, 75005
Institut Curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France, France, 92210
Germany
Universitaetsklinikum Tuebingen
Tuebingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Erlangen
Erlangen, Bayern, Germany, 91054
Interdisziplinäres Onkologisches Zentrum München
München, Bayern, Germany, 80336
Städtisches Krankenhaus München - Neuperlach
München, Bayern, Germany, 81737
Praxis für Frauenheilkunde Anita
München, Bayern, Germany, 81925
Marien Hospital Düsseldorf
Düsseldorf, Nordhein-Westfalen, Germany, 40479
Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde
Essen, Nordrhein-Westfalen, Germany, 45122
Marien Hospital
Witten, Nordrhein-Westfalen, Germany, 58452
Medizinische Fakultät Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Katholisches Marienkrankenhaus gGmbH - Frauenklinik
Hamburg, Germany, 22087
Universtatsklinikum Heidelberg Nationales
Heidelberg, Germany
Israel
Soroka Medical Center [Oncology]
Beersheba, HaDarom, Israel, 84802
The Edith Wolfson Medical Center
Holon, HaMerkaz, Israel, 58100
Meir Medical Center
Kfar Saba, HaMerkaz, Israel, 44281
Rabin Medical Center - Beilinson Hospital
Petaẖ Tiqwa, HaMerkaz, Israel, 49100
The Chaim Sheba Medical Center - Insititute of Oncology
Ramat Gan, HaMerkaz, Israel, 52621
Kaplan Medical Center
Rehovot, HaMerkaz, Israel, 761001
Galilee Medical Center
Nahariya, HaZafon, Israel, 20100
Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem
Jerusalem, Yerushalayim, Israel, 91120
Clalit Health Services - Lin Medical Center
Haifa, Israel, 35152
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania, Cantania, Italy, 95122
Irccs Irst
Meldola, Forli, Italy, 47014
Istituto di Candiolo, IRCCS
Candiolo, Torino, Italy, 10060
Azienda Ospedaliero Universitaria Senese Universita degli St
Siena, Toscana, Italy, 53100
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
Ancona, Italy, 60126
AO G.Rummo
Benevento, Italy, 82100
ASST Papa Giovanni XXIII - Oncologia-Bergamo
Bergamo, Italy, 24127
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
Cremona, Italy, 26100
Arcispedale S.Anna, AOU di Ferrara
Ferrara, Italy, 44124
E.O. Ospedali Galliera
Genova, Italy, 16128
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
Lecco, Italy, 23900
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milano, Italy, 20121
Istituto Europeo di Oncologia Via Ripamonti
Milano, Italy, 20141
AOU Policlinico di Modena
Modena, Italy, 41122
Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori
Napoli, Italy, 80131
AOU di Parma
Parma, Italy, 43126
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
IRCSS Fodazione Salvatore Maugeri
Pavia, Italy, 27100
SO S.Chiara, AOU Pisana
Pisa, Italy, 56126
Nuovo ospedale di Prato
Prato, Italy, 59100
PU Campus Bio-medico di Roma
Roma, Italy, 00128
AO S.Andrea, Università degli Studi di Roma La Sapienza
Roma, Italy, 00189
Ospedale Belcolle Viterbo
Viterbo, Italy, 01100
Korea, Republic of
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Asan Medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229 HX
Stichting Zuyderland Medisch Centrum
Sittard, Limburg, Netherlands, 6162 BG
Elizabeth Tweesteden Ziekenhuis
Tilburg, Noord-Brabant, Netherlands, 5042AD
Haga Ziekenhuis, loc. Leyenburg
Haag, Zuid-Holland, Netherlands, 2545 CH
Poland
MAGODENT Sp. z o.o.
Warszawa, Mazowieckie, Poland, 04-125
Mazowiecki Szpital Onkologiczny
Wieliszew, Mazowieckie, Poland, 05-135
Portugal
Centro Clínico Champalimaud/Fundação Champalimaud
Lisbon, Lisboa, Portugal, 1400-038
H. Santa Maria - Centro Hospitalar Lisboa Norte
Lisboa, Portugal, 1649-035
Instituto Português Oncologia Francisco Gentil do Porto
Porto, Portugal, 4200-072
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 927
Spain
H.U.V. del Rocío
Sevilla, Andalucía, Spain, 41013
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital del Mar
Barcelona, Catalunya, Spain, 08003
H.C.U. Valencia
Valencia, Comunidad, Spain, 46010
H. Madrid Norte Sanchinarro
PAU de Sanchinarro, Madrid, Spain, 28050
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
H.U. Sant Joan de Reus
Reus, Tarragona, Spain, 43204
H.G.U. Alicante
Alicante, Spain, 03010
H. Quirón Barcelona
Barcelona, Spain, 08023
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08023
H. San Pedro de Alcántara
Cáceres, Spain, 10003
ICO-Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain, 17007
H.U. Arnau de Vilanova
Lleida, Spain, 25198
M.D. Anderson Cancer Center Madrid
Madrid, Spain, 28033
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos
Madrid, Spain, 28040
Fundación Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Universitari I Politecnic La Fe
Valencia, Spain, 46026
Hospital Ntra. Sra. de Sonsoles
Ávila, Spain, 5004
United Kingdom
Guys and St Thomas Hospital
London, City Of London, United Kingdom, SE1 9RT
Castle Hill Hospital (Hull)
Hull, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
Kent Oncology Centre, Maidstone Hospital
Maidstone, Kent, United Kingdom, ME16 9QQ
Royal Preston Hospital
Fulwood, Lancashire, United Kingdom, PR2 9HT
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
University Hospital Coventry
Coventry, United Kingdom, CV2 2DX
South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
MacroGenics
Investigators
Layout table for investigator information
Study Director: Edwin Rock, MD PhD MacroGenics

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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT02492711     History of Changes
Other Study ID Numbers: CP-MGAH22-04
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Capecitabine
Trastuzumab
Vinorelbine
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators