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

Primary Purpose

HER-2 Positive Breast Cancer, Metastatic Neoplasm

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Margetuximab
Trastuzumab
Physician's choice of chemotherapy.
Sponsored by
MacroGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER-2 Positive Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ironwood Cancer & Research Center
  • Banner MD Anderson Cancer Center
  • Western Regional Medical Center, Inc.
  • East Valley Hematology And Oncology
  • UCLA Hematology Oncology Santa Monica
  • UC Davis Comprehensive Cancer Center
  • Sharp Memorial Hospital
  • University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
  • Kaiser Permenente Medical Center
  • Poudre Valley Health Care, Inc.
  • MedStar Washington Hospital Center
  • Florida Cancer Specialists
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Mount Sinai Comprehensive Cancer Center
  • Florida Cancer Specialists
  • Orlndo Health Cancer Center
  • Hem-Onc Associates
  • Palm Beach Cancer Center
  • Piedmont Cancer Institute, P.C.
  • Northwest Georgia Oncology Centers, PC
  • CTCA - Southeastern Regional Medical Center
  • Kaiser Permanente Hawaii Moanalua Medical Center
  • Northwestern University Feinberg School of Medicine
  • Rush University Medical Center
  • Carle Cancer Center
  • CTCA - Midwestern Regional Medical Center
  • Indiana University Health Goshen Center for Cancer Care
  • ARH Cancer Clinic
  • St. Joseph's Hospital
  • Touro Infirmary Hospital
  • New England Cancer Specialists
  • Mercy Medical Center
  • Tufts-NEMC Cancer Center
  • Forrest General Hospital
  • Saint Luke's Cancer Specialists
  • Mercy Hospital Saint Louis
  • Dartmouth-Hitchcock - Norris C
  • New Jersey Hematology Oncology Associates
  • Hackensack University Medical Center
  • Saint Barnabas Medical Center - The Cancer Center
  • New Mexico Cancer Care Alliance (NMCCA)
  • Queens Hospital Center
  • ProHEALTH CARE Associates, LLP
  • New York University Clinical Cancer Center
  • Wake Forest University Baptist Medical Center (WFUBMC)
  • Mercy Physicians Of Oklahoma
  • Pinnacle Health Cancer Institute
  • Monongahela Valley Hospital
  • CTCA - Eastern Regional Medical Center, Inc.
  • Guthrie Medical Group, PC
  • Tennessee Oncology, PLLC
  • The Sarah Cannon Research Institute
  • Austin Cancer Center
  • University of Texas Southwestern Medical Center
  • The Center for Cancer and Blood Disorders
  • Utah Cancer Specialists
  • University of Virginia Cancer Center
  • Inova Schar Cancer Institute
  • Fort Belvoir Community Hospital
  • Swedish Cancer Institute/ Swedish Health Services
  • University of Washington/ Seattle Cancer Care Alliance
  • Cancer Care Northwest, PS
  • Medizinische Universität Innsbruck
  • UZ Antwerpen
  • GZA Ziekenhuizen - Campus Sint-Augustinus
  • Clinique Saint-Pierre Ottignies
  • UZ Brussel - Campus Jette
  • Cliniques universitaires Saint-Luc
  • Jessa Ziekenhuis - Campus Virga Jesse
  • AZ Nikolaas - Campus Sint-Niklaas Moerland
  • AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
  • AZ Groeninge - Campus Loofstraat
  • AZ Damiaan
  • Chc - Clinique Saint-Joseph
  • Clinique Sainte Elisabeth
  • Dr. Leon Richard Oncology Centre
  • Lakeridge Health Oshawa
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice v Motole
  • Aarhus Universitetshospital
  • Regionshospitalet Herning (Herning Centralsygehus)
  • Vejle Sygehus
  • Næstved Sygehus
  • Tampere University Hospital
  • Helsinki University Central Hospital (HUCH) - Meilahden Sair
  • Center de Lutte Contre le Cancer (CLCC)
  • Center de Lutte Contre le Cancer (CLCC)
  • Centre Georges-François Lecler
  • Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer
  • Centre Jean Perrin
  • Centre Léon Bérard
  • Institut Curie
  • Institut Curie - Hôpital René Huguenin
  • Universitaetsklinikum Tuebingen
  • Universitätsklinikum Erlangen
  • Praxis für Frauenheilkunde Anita
  • Marien Hospital Düsseldorf
  • Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde
  • Marien Hospital
  • Medizinische Fakultät Carl Gustav Carus
  • Universtatsklinikum Heidelberg Nationales
  • Soroka Medical Center [Oncology]
  • Meir Medical Center
  • Rabin Medical Center - Beilinson Hospital
  • The Chaim Sheba Medical Center - Insititute of Oncology
  • Kaplan Medical Center
  • Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem
  • Clalit Health Services - Lin Medical Center
  • Tel Aviv Sourasky Medical Center
  • PO Garibaldi-Nesima, ARNAS Garibaldi
  • Irccs Irst
  • Istituto di Candiolo, IRCCS
  • Azienda Ospedaliero Universitaria Senese Universita degli St
  • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
  • AO G.Rummo
  • ASST Papa Giovanni XXIII - Oncologia-Bergamo
  • PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
  • Arcispedale S.Anna, AOU di Ferrara
  • E.O. Ospedali Galliera
  • PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
  • Azienda Ospedaliera Fatebenefratelli e Oftalmico
  • Istituto Europeo di Oncologia Via Ripamonti
  • AOU Policlinico di Modena
  • Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori
  • AOU di Parma
  • IRCCS Policlinico San Matteo
  • IRCSS Fodazione Salvatore Maugeri
  • SO S.Chiara, AOU Pisana
  • Nuovo ospedale di Prato
  • PU Campus Bio-medico di Roma
  • AO S.Andrea, Università degli Studi di Roma La Sapienza
  • Ospedale Belcolle Viterbo
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Maastricht University Medical Centre
  • Haga Ziekenhuis, loc. Leyenburg
  • MAGODENT Sp. z o.o.
  • Mazowiecki Szpital Onkologiczny
  • Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
  • Centro Clínico Champalimaud/Fundação Champalimaud
  • H. Santa Maria - Centro Hospitalar Lisboa Norte
  • Instituto Português Oncologia Francisco Gentil do Porto
  • Fundacion de Investigacion de Diego
  • H.U.V. del Rocío
  • Institut Català d'Oncologia-Hospital Germans Trias i Pujol
  • Hospital Universitari Parc Taulí
  • Hospital del Mar
  • H.C.U. Valencia
  • Hospital de Navarra
  • H.U. Sant Joan de Reus
  • Hospital Universitario Vall d'Hebron
  • H. San Pedro de Alcántara
  • H.U. Arnau de Vilanova
  • M.D. Anderson Cancer Center Madrid
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Clínico San Carlos
  • Fundación Instituto Valenciano de Oncología
  • Hospital Universitari I Politecnic La Fe
  • Hospital Ntra. Sra. de Sonsoles
  • Guys and St Thomas Hospital
  • Castle Hill Hospital (Hull)
  • Kent Oncology Centre, Maidstone Hospital
  • Royal Preston Hospital
  • South Tees Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Margetuximab plus chemotherapy

Trastuzumab plus chemotherapy

Margetuximab Infusion Sub-study

Arm Description

Margetuximab 15 mg/kg every 21 days

Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days

Margetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2.

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
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
Infusion Rate Sub-study All Safety
Incidence of all grades of infusion-related reactions

Full Information

First Posted
July 6, 2015
Last Updated
October 28, 2022
Sponsor
MacroGenics
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1. Study Identification

Unique Protocol Identification Number
NCT02492711
Brief Title
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
Acronym
SOPHIA
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 Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2015 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER-2 Positive Breast Cancer, Metastatic Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
624 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Margetuximab plus chemotherapy
Arm Type
Experimental
Arm Description
Margetuximab 15 mg/kg every 21 days
Arm Title
Trastuzumab plus chemotherapy
Arm Type
Active Comparator
Arm Description
Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days
Arm Title
Margetuximab Infusion Sub-study
Arm Type
Experimental
Arm Description
Margetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2.
Intervention Type
Biological
Intervention Name(s)
Margetuximab
Other Intervention Name(s)
MGAH22, Margenza®
Intervention Description
15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Physician's choice of chemotherapy.
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) as Determined by Independent Radiological Review.
Description
PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.
Time Frame
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.
Title
Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).
Description
Overall survival is the time from randomization until death from any cause
Time Frame
Throughout the study, average 21 months
Title
Number of Patients With Grade 3 or Higher Infusion Related Reactions
Description
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
Time Frame
22 days
Secondary Outcome Measure Information:
Title
To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
Time Frame
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.
Title
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review.
Description
Objective response rate includes all patients with either a complete response (CR) or a partial response (PR) to study treatment
Time Frame
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.
Title
Infusion Rate Sub-study All Safety
Description
Incidence of all grades of infusion-related reactions
Time Frame
Throughout the study, average duration 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen L Eck, M.D., Ph.D.
Organizational Affiliation
MacroGenics
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Cancer & Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Western Regional Medical Center, Inc.
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
East Valley Hematology And Oncology
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
UCLA Hematology Oncology Santa Monica
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permenente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Poudre Valley Health Care, Inc.
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Cancer Specialists
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Orlndo Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Hem-Onc Associates
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Palm Beach Cancer Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Piedmont Cancer Institute, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
CTCA - Southeastern Regional Medical Center
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Kaiser Permanente Hawaii Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CTCA - Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Indiana University Health Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
ARH Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
St. Joseph's Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Touro Infirmary Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Tufts-NEMC Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Forrest General Hospital
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Saint Luke's Cancer Specialists
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Dartmouth-Hitchcock - Norris C
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New Jersey Hematology Oncology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Saint Barnabas Medical Center - The Cancer Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
New Mexico Cancer Care Alliance (NMCCA)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Queens Hospital Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
ProHEALTH CARE Associates, LLP
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
New York University Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Wake Forest University Baptist Medical Center (WFUBMC)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Mercy Physicians Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Pinnacle Health Cancer Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
Monongahela Valley Hospital
City
Monongahela
State/Province
Pennsylvania
ZIP/Postal Code
15063
Country
United States
Facility Name
CTCA - Eastern Regional Medical Center, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Guthrie Medical Group, PC
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Swedish Cancer Institute/ Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington/ Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Cancer Care Northwest, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GZA Ziekenhuizen - Campus Sint-Augustinus
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Clinique Saint-Pierre Ottignies
City
Ottignies
State/Province
Brabant Wallon
ZIP/Postal Code
1340
Country
Belgium
Facility Name
UZ Brussel - Campus Jette
City
Brussels
State/Province
Brussels Capital Region
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Brussels Capital Region
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Nikolaas - Campus Sint-Niklaas Moerland
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Facility Name
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
AZ Groeninge - Campus Loofstraat
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
AZ Damiaan
City
Oostende
State/Province
West-Vlaanderen
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Chc - Clinique Saint-Joseph
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Dr. Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Masarykuv onkologicky ustav
City
Brno
State/Province
Brno-město
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Aarhus Universitetshospital
City
Aarhus C
State/Province
Central Jutland
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Regionshospitalet Herning (Herning Centralsygehus)
City
Herning
State/Province
Central Jutland
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
State/Province
South Denmark
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Næstved Sygehus
City
Aarhus N
State/Province
Zeeland
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Etelä-Suomen Lääni
ZIP/Postal Code
33521
Country
Finland
Facility Name
Helsinki University Central Hospital (HUCH) - Meilahden Sair
City
Helsinki
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
00029
Country
Finland
Facility Name
Center de Lutte Contre le Cancer (CLCC)
City
Nice
State/Province
Alpes-Martitimes
ZIP/Postal Code
06189
Country
France
Facility Name
Center de Lutte Contre le Cancer (CLCC)
City
Caen cedex 05
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges-François Lecler
City
Dijon
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer
City
St Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Léon Bérard
City
Lyon Cedex 08
State/Province
Rhône-Alpes
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Curie
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75005
Country
France
Facility Name
Institut Curie - Hôpital René Huguenin
City
Saint-Cloud
State/Province
Île-de-France
ZIP/Postal Code
92210
Country
France
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Praxis für Frauenheilkunde Anita
City
München
State/Province
Bayern
ZIP/Postal Code
81925
Country
Germany
Facility Name
Marien Hospital Düsseldorf
City
Düsseldorf
State/Province
Nordhein-Westfalen
ZIP/Postal Code
40479
Country
Germany
Facility Name
Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Marien Hospital
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58452
Country
Germany
Facility Name
Medizinische Fakultät Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universtatsklinikum Heidelberg Nationales
City
Heidelberg
Country
Germany
Facility Name
Soroka Medical Center [Oncology]
City
Beersheba
State/Province
HaDarom
ZIP/Postal Code
84802
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
State/Province
HaMerkaz
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petaẖ Tiqwa
State/Province
HaMerkaz
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center - Insititute of Oncology
City
Ramat Gan
State/Province
HaMerkaz
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
State/Province
HaMerkaz
ZIP/Postal Code
761001
Country
Israel
Facility Name
Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Clalit Health Services - Lin Medical Center
City
Haifa
ZIP/Postal Code
35152
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
PO Garibaldi-Nesima, ARNAS Garibaldi
City
Catania
State/Province
Cantania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Irccs Irst
City
Meldola
State/Province
Forli
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto di Candiolo, IRCCS
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Senese Universita degli St
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
AO G.Rummo
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
ASST Papa Giovanni XXIII - Oncologia-Bergamo
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Arcispedale S.Anna, AOU di Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
E.O. Ospedali Galliera
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda Ospedaliera Fatebenefratelli e Oftalmico
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Istituto Europeo di Oncologia Via Ripamonti
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
AOU Policlinico di Modena
City
Modena
ZIP/Postal Code
41122
Country
Italy
Facility Name
Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCSS Fodazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
SO S.Chiara, AOU Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Nuovo ospedale di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
PU Campus Bio-medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
AO S.Andrea, Università degli Studi di Roma La Sapienza
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Ospedale Belcolle Viterbo
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Haga Ziekenhuis, loc. Leyenburg
City
Haag
State/Province
Zuid-Holland
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
MAGODENT Sp. z o.o.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Mazowiecki Szpital Onkologiczny
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Centro Clínico Champalimaud/Fundação Champalimaud
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
H. Santa Maria - Centro Hospitalar Lisboa Norte
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Português Oncologia Francisco Gentil do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
927
Country
Puerto Rico
Facility Name
H.U.V. del Rocío
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Institut Català d'Oncologia-Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
H.C.U. Valencia
City
Valencia
State/Province
Comunidad
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
H.U. Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
H. San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
H.U. Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
M.D. Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitari I Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Ntra. Sra. de Sonsoles
City
Ávila
ZIP/Postal Code
5004
Country
Spain
Facility Name
Guys and St Thomas Hospital
City
London
State/Province
City Of London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Castle Hill Hospital (Hull)
City
Hull
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Kent Oncology Centre, Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Fulwood
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36332179
Citation
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.
Results Reference
derived
PubMed Identifier
33480963
Citation
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.
Results Reference
derived

Learn more about this trial

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

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