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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02492711
Other study ID # CP-MGAH22-04
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 24, 2015
Est. completion date June 14, 2022

Study information

Verified date October 2022
Source MacroGenics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 624
Est. completion date June 14, 2022
Est. primary completion date August 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Biological:
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
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

Locations

Country Name City State
Austria Medizinische Universität Innsbruck Innsbruck Tirol
Belgium AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan Brugge West-Vlaanderen
Belgium Cliniques universitaires Saint-Luc Brussels Brussels Capital Region
Belgium UZ Brussel - Campus Jette Brussels Brussels Capital Region
Belgium UZ Antwerpen Edegem Antwerpen
Belgium Jessa Ziekenhuis - Campus Virga Jesse Hasselt Limburg
Belgium AZ Groeninge - Campus Loofstraat Kortrijk West-Vlaanderen
Belgium Chc - Clinique Saint-Joseph Liège
Belgium Clinique Sainte Elisabeth Namur
Belgium AZ Damiaan Oostende West-Vlaanderen
Belgium Clinique Saint-Pierre Ottignies Ottignies Brabant Wallon
Belgium AZ Nikolaas - Campus Sint-Niklaas Moerland Sint-Niklaas Oost-Vlaanderen
Belgium GZA Ziekenhuizen - Campus Sint-Augustinus Wilrijk Antwerpen
Canada Dr. Leon Richard Oncology Centre Moncton New Brunswick
Canada Lakeridge Health Oshawa Oshawa Ontario
Czechia Masarykuv onkologicky ustav Brno Brno-mesto
Czechia Fakultni nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice v Motole Praha 5
Denmark Aarhus Universitetshospital Aarhus C Central Jutland
Denmark Næstved Sygehus Aarhus N Zeeland
Denmark Regionshospitalet Herning (Herning Centralsygehus) Herning Central Jutland
Denmark Vejle Sygehus Vejle South Denmark
Finland Helsinki University Central Hospital (HUCH) - Meilahden Sair Helsinki Länsi-Suomen Lääni
Finland Tampere University Hospital Tampere Etelä-Suomen Lääni
France Center de Lutte Contre le Cancer (CLCC) Caen cedex 05 Calvados
France Centre Jean Perrin Clermont-Ferrand Puy-de-Dôme
France Centre Georges-François Lecler Dijon Côte-d'Or
France Centre Léon Bérard Lyon Cedex 08 Rhône-Alpes
France Center de Lutte Contre le Cancer (CLCC) Nice Alpes-Martitimes
France Institut Curie Paris Île-de-France
France Institut Curie - Hôpital René Huguenin Saint-Cloud Île-de-France
France Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer St Herblain Loire-Atlantique
Germany Medizinische Fakultät Carl Gustav Carus Dresden Sachsen
Germany Marien Hospital Düsseldorf Düsseldorf Nordhein-Westfalen
Germany Universitätsklinikum Erlangen Erlangen Bayern
Germany Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde Essen Nordrhein-Westfalen
Germany Universtatsklinikum Heidelberg Nationales Heidelberg
Germany Praxis für Frauenheilkunde Anita München Bayern
Germany Universitaetsklinikum Tuebingen Tuebingen Baden-Württemberg
Germany Marien Hospital Witten Nordrhein-Westfalen
Israel Soroka Medical Center [Oncology] Beersheba HaDarom
Israel Clalit Health Services - Lin Medical Center Haifa
Israel Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem Jerusalem Yerushalayim
Israel Meir Medical Center Kfar Saba HaMerkaz
Israel Rabin Medical Center - Beilinson Hospital Peta? Tiqwa HaMerkaz
Israel The Chaim Sheba Medical Center - Insititute of Oncology Ramat Gan HaMerkaz
Israel Kaplan Medical Center Rehovot HaMerkaz
Israel Tel Aviv Sourasky Medical Center Tel Aviv
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 Istituto di Candiolo, IRCCS Candiolo Torino
Italy PO Garibaldi-Nesima, ARNAS Garibaldi Catania Cantania
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 Irccs Irst Meldola Forli
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 AO S.Andrea, Università degli Studi di Roma La Sapienza Roma
Italy PU Campus Bio-medico di Roma Roma
Italy Azienda Ospedaliero Universitaria Senese Universita degli St Siena Toscana
Italy Ospedale Belcolle Viterbo Viterbo
Korea, Republic of Asan Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Samsung Medical Center Seoul Seoul Teugbyeolsi
Korea, Republic of Seoul National University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul Teugbyeolsi
Netherlands Haga Ziekenhuis, loc. Leyenburg Haag Zuid-Holland
Netherlands Maastricht University Medical Centre Maastricht Limburg
Poland Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli Lublin
Poland MAGODENT Sp. z o.o. Warszawa Mazowieckie
Poland Mazowiecki Szpital Onkologiczny Wieliszew Mazowieckie
Portugal H. Santa Maria - Centro Hospitalar Lisboa Norte Lisboa
Portugal Centro Clínico Champalimaud/Fundação Champalimaud Lisbon Lisboa
Portugal Instituto Português Oncologia Francisco Gentil do Porto Porto
Puerto Rico Fundacion de Investigacion de Diego San Juan
Spain Hospital Ntra. Sra. de Sonsoles Ávila
Spain Institut Català d'Oncologia-Hospital Germans Trias i Pujol Badalona Barcelona
Spain Hospital del Mar Barcelona Catalunya
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain H. San Pedro de Alcántara Cáceres
Spain H.U. Arnau de Vilanova Lleida
Spain Hospital Universitario Clínico San Carlos Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain M.D. Anderson Cancer Center Madrid Madrid
Spain Hospital de Navarra Pamplona Navarra
Spain H.U. Sant Joan de Reus Reus Tarragona
Spain Hospital Universitari Parc Taulí Sabadell Barcelona
Spain H.U.V. del Rocío Sevilla Andalucía
Spain Fundación Instituto Valenciano de Oncología Valencia
Spain H.C.U. Valencia Valencia Comunidad
Spain Hospital Universitari I Politecnic La Fe Valencia
United Kingdom Royal Preston Hospital Fulwood Lancashire
United Kingdom Castle Hill Hospital (Hull) Hull East Riding Of Yorkshire
United Kingdom Guys and St Thomas Hospital London City Of London
United Kingdom Kent Oncology Centre, Maidstone Hospital Maidstone Kent
United Kingdom South Tees Hospitals NHS Foundation Trust Middlesbrough
United States New Mexico Cancer Care Alliance (NMCCA) Albuquerque New Mexico
United States Piedmont Cancer Institute, P.C. Atlanta Georgia
United States Austin Cancer Center Austin Texas
United States Mercy Medical Center Baltimore Maryland
United States Tufts-NEMC Cancer Center Boston Massachusetts
United States New Jersey Hematology Oncology Associates Brick New Jersey
United States East Valley Hematology And Oncology Burbank California
United States Ironwood Cancer & Research Center Chandler Arizona
United States University of Virginia Cancer Center Charlottesville Virginia
United States Tennessee Oncology, PLLC Chattanooga Tennessee
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Texas Southwestern Medical Center Dallas Texas
United States Inova Schar Cancer Institute Fairfax Virginia
United States Fort Belvoir Community Hospital Fort Belvoir Virginia
United States Poudre Valley Health Care, Inc. Fort Collins Colorado
United States Florida Cancer Specialists Fort Myers Florida
United States The Center for Cancer and Blood Disorders Fort Worth Texas
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Western Regional Medical Center, Inc. Goodyear Arizona
United States Indiana University Health Goshen Center for Cancer Care Goshen Indiana
United States Hackensack University Medical Center Hackensack New Jersey
United States Pinnacle Health Cancer Institute Harrisburg Pennsylvania
United States Forrest General Hospital Hattiesburg Mississippi
United States ARH Cancer Clinic Hazard Kentucky
United States Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida
United States Kaiser Permanente Hawaii Moanalua Medical Center Honolulu Hawaii
United States Queens Hospital Center Jamaica New York
United States Saint Luke's Cancer Specialists Kansas City Missouri
United States ProHEALTH CARE Associates, LLP Lake Success New York
United States Dartmouth-Hitchcock - Norris C Lebanon New Hampshire
United States St. Joseph's Hospital Lexington Kentucky
United States Saint Barnabas Medical Center - The Cancer Center Livingston New Jersey
United States UCLA Hematology Oncology Santa Monica Los Angeles California
United States Northwest Georgia Oncology Centers, PC Marietta Georgia
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Monongahela Valley Hospital Monongahela Pennsylvania
United States The Sarah Cannon Research Institute Nashville Tennessee
United States Touro Infirmary Hospital New Orleans Louisiana
United States Florida Cancer Specialists New Port Richey Florida
United States New York University Clinical Cancer Center New York New York
United States CTCA - Southeastern Regional Medical Center Newnan Georgia
United States Mercy Physicians Of Oklahoma Oklahoma City Oklahoma
United States Orlndo Health Cancer Center Orlando Florida
United States CTCA - Eastern Regional Medical Center, Inc. Philadelphia Pennsylvania
United States Hem-Onc Associates Port Saint Lucie Florida
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Utah Cancer Specialists Salt Lake City Utah
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 Guthrie Medical Group, PC Sayre Pennsylvania
United States New England Cancer Specialists Scarborough Maine
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 Carle Cancer Center Urbana Illinois
United States Kaiser Permenente Medical Center Vallejo California
United States MedStar Washington Hospital Center Washington District of Columbia
United States Palm Beach Cancer Center West Palm Beach Florida
United States Wake Forest University Baptist Medical Center (WFUBMC) Winston-Salem North Carolina
United States CTCA - Midwestern Regional Medical Center Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
MacroGenics

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) as Determined by Independent Radiological Review. PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first. Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.
Primary Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause). Overall survival is the time from randomization until death from any cause Throughout the study, average 21 months
Primary Number of Patients With Grade 3 or Higher Infusion Related Reactions Incidence of Grade 3 or higher infusion-related reactions for patients receiving 60-minute or 30-minute infusions of margetuximab in Cycle 2 of treatment 22 days
Secondary To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators. Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Secondary To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review. Objective response rate includes all patients with either a complete response (CR) or a partial response (PR) to study treatment Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Secondary Infusion Rate Sub-study All Safety Incidence of all grades of infusion-related reactions Throughout the study, average duration 6 months
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