search
Back to results

MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients (HERMIONE)

Primary Purpose

Breast Cancer, HER2 Positive Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MM-302
Gemcitabine
Capecitabine
Vinorelbine
Trastuzumab
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HER2-positive, HER2+, HER2, Locally Advanced Breast Cancer, Metastatic Breast Cancer, trastuzumab, Herceptin, pertuzumab, ado-trastuzumab emtansine, TDM-1, Perjeta, Kadcyla

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed invasive cancer of the breast
  • Patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent.
  • Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory
  • Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
  • Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the LABC/MBC setting
  • Patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab)
  • ECOG Performance Status of 0 or 1

Exclusion Criteria:

  • Patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative
  • Subjects with central nervous system (CNS) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment
  • Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF)
  • Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
  • Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
  • Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
  • Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.

Sites / Locations

  • Palo Verde Cancer Center
  • Mayo Clinic Cancer Center
  • University of Arizona Cancer Center
  • St. Jude Heritage Healthcare
  • UC San Diego Moores Cancer Center
  • Ronald Reagan UCLA Medical Center
  • Cancer Care Associates Medical Group
  • UCSF Medical Center
  • Sansum Clinic
  • Kaiser Permanent Medical Center
  • University of Colorado Cancer Center
  • Rocky Mountain Cancer Centers
  • Smilow Cancer Hospital at Yale New Haven Hospital
  • Washington Cancer Institute
  • Florida Cancer Specialists & Research Institute
  • Memorial Regional Hospital
  • Mayo Clinic Cancer Center
  • Sarah Cannon Research Institute
  • UF Health Cancer Center at Orlando Health
  • Florida Cancer Research Institute
  • University of Miami Comprehensive Cancer Center
  • Southeastern Regional Medical Center
  • Northwestern University- Robert H. Lurie Comprehensive Cancer Center
  • Rush University Medical Center
  • University of Chicago
  • Joliet Oncology-Hematology Associates
  • Midwestern Regional Medical Center
  • Indiana University Melvin and Bren Simon Cancer Center
  • McFarland Clinic PC
  • Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • St. Joseph Mercy Hospital
  • University of Michigan Health System
  • Minnesota Oncology Hematology
  • University of Minnesota- Masonic Cancer Center
  • Mayo Clinic Cancer Center
  • Saint Luke's Hospital
  • Barnes-Jewish West County Hospital
  • Hackensack University Medical Center
  • New Mexico Cancer Care Alliance
  • New York Oncology Hematology, P.C.
  • Montefiore Medical Center
  • North Shore Hematology Oncology Associates
  • Morton Coleman MD
  • NYU Langone Medical Center
  • Office of Carey K. Anders
  • Duke Cancer Institute
  • Oncology Hematology Care
  • Cleveland Clinic
  • Ohio State University Hospital
  • St. Charles Health System
  • Magee-Womens Hospital of UPMC
  • Bon Secours Saint Francis Hospital Cancer Center
  • Greenville Health System Cancer Institute
  • Tennessee Oncology
  • The Sarah Cannon Research Institute
  • Vanderbilt University Medical Center
  • Texas Oncology- Central Austin Cancer Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Texas Oncology- Medical City
  • Texas Oncology
  • The Center for Cancer and Blood Disorders
  • Texas Oncology-Houston Memorial City
  • The University of Texas- MD Anderson Cancer Center
  • Cancer Care Centers of South Texas
  • Texas Oncology
  • Huntsman Cancer Institute
  • Virginia Oncology Associate
  • Swedish Medical Center
  • Northwest Medical Specialties
  • Medizinische Universitat Innsbruck
  • AKh Allgemeines Krankenhaus der Stadt Linz
  • Medical University of Vienna
  • GZA Ziekenhuizen - Campus Sint-Augustinus
  • University Hospital Antwerp
  • Cliniques Universitaires Saint-Luc
  • Clinique Saint-Joseph
  • London Regional Cancer Center
  • Sunnybrook Health Sciences Centre
  • University of Alberta- Cross Cancer Institute
  • McGill University Health Center
  • Motol University Hospital
  • Institut de Cancerologie de l'Ouest site Paul Papin
  • Centre Léon Bérard
  • Hopital de l'Institut Curie
  • Institut de Cancerologie de l'Ouest
  • Institut Claudius Regaud
  • Universitatsklinikum des Saarlandes
  • Universitätsklinikum Schleswig-Holstein
  • Interdisziplinares Onkologisches Zentrum
  • Istituto Clinico Humanitas
  • Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
  • Azienda Ospedaliero-Universitaria di Bologna
  • Azienda Socio Sanitaria Territoriale di Cremona
  • Oncology Unit Macerata Hospital
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
  • Instituto Oncologico Veneto IRCCS
  • Azienda Ospedaliero S. Maria di Terni
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario Reina Sofía
  • Hospital San Pedro de Alcantara
  • Hospital Universitario Arnau de Vilanova
  • Hospital Clinico San Carlos
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Ramon y Cajal
  • H.U.Son Espases
  • Hospital de Navarra
  • Hospital Universitario Virgen de la Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MM-302 + trastuzumab

Chemotherapy of Physician's Choice plus trastuzumab

Arm Description

MM-302 + trastuzumab

Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine

Outcomes

Primary Outcome Measures

Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary Outcome Measures

Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Overall Survival
Time to Treatment Failure
Objective Response Rate based on independent and investigator review of tumor assessments
Duration of Response (DoR) based on independent and investigator review of tumor assessments
Safety
We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm
Pharmacokinetic exposure of MM-302
Area Under Curve (AUC) Time Frame: Cycles 1 and 2 - pre-infusion, post-infusion, and 168 hours post-dose. An optional timepoint at 8-96 hours post infusion is included during both cycles as well.

Full Information

First Posted
August 6, 2014
Last Updated
January 4, 2017
Sponsor
Merrimack Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02213744
Brief Title
MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients
Acronym
HERMIONE
Official Title
A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Felt not to show benefit over control per DMC and confirmed via futility analysis
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, HER2 Positive Breast Cancer
Keywords
HER2-positive, HER2+, HER2, Locally Advanced Breast Cancer, Metastatic Breast Cancer, trastuzumab, Herceptin, pertuzumab, ado-trastuzumab emtansine, TDM-1, Perjeta, Kadcyla

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MM-302 + trastuzumab
Arm Type
Experimental
Arm Description
MM-302 + trastuzumab
Arm Title
Chemotherapy of Physician's Choice plus trastuzumab
Arm Type
Active Comparator
Arm Description
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
Intervention Type
Drug
Intervention Name(s)
MM-302
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Primary Outcome Measure Information:
Title
Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
Approximately 2 years
Secondary Outcome Measure Information:
Title
Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
Approximately 2 years
Title
Overall Survival
Time Frame
Approximately 3 years
Title
Time to Treatment Failure
Time Frame
Approximately 2 years
Title
Objective Response Rate based on independent and investigator review of tumor assessments
Time Frame
Approximately 2 years
Title
Duration of Response (DoR) based on independent and investigator review of tumor assessments
Time Frame
Approximately 2 years
Title
Safety
Description
We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm
Time Frame
Approximately 2 years
Title
Pharmacokinetic exposure of MM-302
Description
Area Under Curve (AUC) Time Frame: Cycles 1 and 2 - pre-infusion, post-infusion, and 168 hours post-dose. An optional timepoint at 8-96 hours post infusion is included during both cycles as well.
Time Frame
Approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed invasive cancer of the breast Patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent. Patients must have HER2-positive breast cancer as defined by ASCO/CAP 2013 guidelines that is confirmed by a Sponsor-designated central laboratory Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. Patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the LABC/MBC setting Patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab) ECOG Performance Status of 0 or 1 Exclusion Criteria: Patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative Subjects with central nervous system (CNS) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF) Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia) Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.
Facility Information:
Facility Name
Palo Verde Cancer Center
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Cancer Care Associates Medical Group
City
Redondo Beach
State/Province
California
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
Country
United States
Facility Name
Kaiser Permanent Medical Center
City
Vallejo
State/Province
California
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
Country
United States
Facility Name
Smilow Cancer Hospital at Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Fort Meyers
State/Province
Florida
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Sarah Cannon Research Institute
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
UF Health Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Florida Cancer Research Institute
City
Plantation
State/Province
Florida
Country
United States
Facility Name
University of Miami Comprehensive Cancer Center
City
Plantation
State/Province
Florida
Country
United States
Facility Name
Southeastern Regional Medical Center
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Northwestern University- Robert H. Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Joliet Oncology-Hematology Associates
City
Joliet
State/Province
Illinois
Country
United States
Facility Name
Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
McFarland Clinic PC
City
Ames
State/Province
Iowa
Country
United States
Facility Name
Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Minnesota Oncology Hematology
City
Coon Rapids
State/Province
Minnesota
Country
United States
Facility Name
University of Minnesota- Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Barnes-Jewish West County Hospital
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
East Setauket
State/Province
New York
Country
United States
Facility Name
Morton Coleman MD
City
New York
State/Province
New York
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Office of Carey K. Anders
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ohio State University Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
St. Charles Health System
City
Bend
State/Province
Oregon
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Bon Secours Saint Francis Hospital Cancer Center
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Greenville Health System Cancer Institute
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Tennessee Oncology
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology- Central Austin Cancer Center
City
Austin
State/Province
Texas
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas Oncology- Medical City
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas Oncology
City
El Paso
State/Province
Texas
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Texas Oncology-Houston Memorial City
City
Houston
State/Province
Texas
Country
United States
Facility Name
The University of Texas- MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Texas Oncology
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Virginia Oncology Associate
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Swedish Medical Center
City
Issaquah
State/Province
Washington
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Medizinische Universitat Innsbruck
City
Innsbruck
Country
Austria
Facility Name
AKh Allgemeines Krankenhaus der Stadt Linz
City
Linz
Country
Austria
Facility Name
Medical University of Vienna
City
Wien
Country
Austria
Facility Name
GZA Ziekenhuizen - Campus Sint-Augustinus
City
Antwerp
Country
Belgium
Facility Name
University Hospital Antwerp
City
Antwerp
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
Clinique Saint-Joseph
City
Liege
Country
Belgium
Facility Name
London Regional Cancer Center
City
London
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University of Alberta- Cross Cancer Institute
City
Edmonton
Country
Canada
Facility Name
McGill University Health Center
City
Quebec
Country
Canada
Facility Name
Motol University Hospital
City
Prague
Country
Czech Republic
Facility Name
Institut de Cancerologie de l'Ouest site Paul Papin
City
Angers
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hopital de l'Institut Curie
City
Paris
Country
France
Facility Name
Institut de Cancerologie de l'Ouest
City
Saint-Herblain
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
Facility Name
Universitatsklinikum des Saarlandes
City
Homburg
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lubeck
Country
Germany
Facility Name
Interdisziplinares Onkologisches Zentrum
City
Munich
Country
Germany
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
Country
Italy
Facility Name
Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
City
Aviano
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna
City
Bologna
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona
City
Cremina
Country
Italy
Facility Name
Oncology Unit Macerata Hospital
City
Macerata
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milan
Country
Italy
Facility Name
Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
City
Napoli
Country
Italy
Facility Name
Instituto Oncologico Veneto IRCCS
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliero S. Maria di Terni
City
Terni
Country
Italy
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
Country
Spain
Facility Name
Hospital Universitario Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
H.U.Son Espases
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27259714
Citation
Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naive, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer. 2016 Jun 3;16:352. doi: 10.1186/s12885-016-2385-z.
Results Reference
derived

Learn more about this trial

MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients

We'll reach out to this number within 24 hrs