MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients (HERMIONE)
2017年1月4日 更新者：Merrimack Pharmaceuticals
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
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.
研究概览
研究类型
介入性
注册 (实际的)
113
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Edmonton、加拿大
- University of Alberta- Cross Cancer Institute
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Quebec、加拿大
- McGill University Health Center
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Ontario
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London、Ontario、加拿大
- London Regional Cancer Center
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Toronto、Ontario、加拿大
- Sunnybrook Health Sciences Centre
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Innsbruck、奥地利
- Medizinische Universität Innsbruck
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Linz、奥地利
- AKh Allgemeines Krankenhaus der Stadt Linz
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Wien、奥地利
- Medical University of Vienna
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Homburg、德国
- Universitatsklinikum des Saarlandes
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Lubeck、德国
- Universitatsklinikum Schleswig-Holstein
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Munich、德国
- Interdisziplinares Onkologisches Zentrum
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Aviano、意大利
- Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori
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Bologna、意大利
- Azienda ospedaliero-universitaria di Bologna
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Cremina、意大利
- Azienda Socio Sanitaria Territoriale di Cremona
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Macerata、意大利
- Oncology Unit Macerata Hospital
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Milan、意大利
- Istituto Europeo di Oncologia
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Napoli、意大利
- Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale
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Padova、意大利
- Instituto Oncologico Veneto IRCCS
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Terni、意大利
- Azienda Ospedaliero S. Maria di Terni
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Milan
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Rozzano、Milan、意大利
- Istituto Clinico Humanitas
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Prague、捷克共和国
- Motol University Hospital
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Antwerp、比利时
- University Hospital Antwerp
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Antwerp、比利时
- GZA Ziekenhuizen - Campus Sint-Augustinus
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Brussels、比利时
- Cliniques universitaires Saint-Luc
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Liege、比利时
- Clinique Saint-Joseph
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Angers、法国
- Institut de Cancerologie de l'Ouest site Paul Papin
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Lyon、法国
- Centre Léon Bérard
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Paris、法国
- Hopital de l'Institut Curie
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Saint-Herblain、法国
- Institut de Cancérologie de l'Ouest
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Toulouse、法国
- Institut Claudius Regaud
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Arizona
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Glendale、Arizona、美国
- Palo Verde Cancer Center
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Scottsdale、Arizona、美国
- Mayo Clinic Cancer Center
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Tucson、Arizona、美国
- University of Arizona Cancer Center
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California
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Fullerton、California、美国
- St. Jude Heritage Healthcare
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La Jolla、California、美国
- UC San Diego Moores Cancer Center
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Los Angeles、California、美国
- Ronald Reagan UCLA Medical Center
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Redondo Beach、California、美国
- Cancer Care Associates Medical Group
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San Francisco、California、美国
- UCSF Medical Center
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Santa Barbara、California、美国
- Sansum Clinic
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Vallejo、California、美国
- Kaiser Permanent Medical Center
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Colorado
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Aurora、Colorado、美国
- University of Colorado Cancer Center
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Littleton、Colorado、美国
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven、Connecticut、美国
- Smilow Cancer Hospital At Yale New Haven Hospital
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District of Columbia
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Washington、District of Columbia、美国
- Washington Cancer Institute
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Florida
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Fort Meyers、Florida、美国
- Florida Cancer Specialists & Research Institute
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Hollywood、Florida、美国
- Memorial Regional Hospital
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Jacksonville、Florida、美国
- Mayo Clinic Cancer Center
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New Port Richey、Florida、美国
- Sarah Cannon Research Institute
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Orlando、Florida、美国
- UF Health Cancer Center at Orlando Health
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Plantation、Florida、美国
- Florida Cancer Research Institute
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Plantation、Florida、美国
- University of Miami Comprehensive Cancer Center
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Georgia
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Newnan、Georgia、美国
- Southeastern Regional Medical Center
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Illinois
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Chicago、Illinois、美国
- University of Chicago
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Chicago、Illinois、美国
- Rush University Medical Center
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Chicago、Illinois、美国
- Northwestern University- Robert H. Lurie Comprehensive Cancer Center
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Joliet、Illinois、美国
- Joliet Oncology-Hematology Associates
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Zion、Illinois、美国
- Midwestern Regional Medical Center
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Indiana
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Indianapolis、Indiana、美国
- Indiana University Melvin and Bren Simon Cancer Center
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Iowa
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Ames、Iowa、美国
- McFarland Clinic PC
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Maryland
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Baltimore、Maryland、美国
- Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston、Massachusetts、美国
- Dana-Farber Cancer Institute
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Michigan
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Ann Arbor、Michigan、美国
- University of Michigan Health System
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Ann Arbor、Michigan、美国
- St. Joseph Mercy Hospital
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Minnesota
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Coon Rapids、Minnesota、美国
- Minnesota Oncology Hematology
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Minneapolis、Minnesota、美国
- University of Minnesota- Masonic Cancer Center
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Rochester、Minnesota、美国
- Mayo Clinic Cancer Center
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Missouri
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Kansas City、Missouri、美国
- Saint Luke's Hospital
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St. Louis、Missouri、美国
- Barnes-Jewish West County Hospital
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New Jersey
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Hackensack、New Jersey、美国
- Hackensack University Medical Center
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New Mexico
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Albuquerque、New Mexico、美国
- New Mexico Cancer Care Alliance
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New York
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Albany、New York、美国
- New York Oncology Hematology, P.C.
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Bronx、New York、美国
- Montefiore Medical Center
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East Setauket、New York、美国
- North Shore Hematology Oncology Associates
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New York、New York、美国
- NYU Langone Medical Center
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New York、New York、美国
- Morton Coleman MD
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North Carolina
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Chapel Hill、North Carolina、美国
- Office of Carey K. Anders
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Durham、North Carolina、美国
- Duke Cancer Institute
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Ohio
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Cincinnati、Ohio、美国
- Oncology Hematology Care
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Cleveland、Ohio、美国
- Cleveland Clinic
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Columbus、Ohio、美国
- Ohio State University Hospital
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Oregon
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Bend、Oregon、美国
- St. Charles Health System
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Pennsylvania
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Pittsburgh、Pennsylvania、美国
- Magee-Womens Hospital of UPMC
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South Carolina
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Greenville、South Carolina、美国
- Bon Secours Saint Francis Hospital Cancer Center
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Greenville、South Carolina、美国
- Greenville Health System Cancer Institute
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Tennessee
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Chattanooga、Tennessee、美国
- Tennessee Oncology
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Nashville、Tennessee、美国
- Vanderbilt University Medical Center
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Nashville、Tennessee、美国
- The Sarah Cannon Research Institute
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Texas
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Austin、Texas、美国
- Texas Oncology- Central Austin Cancer Center
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Dallas、Texas、美国
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Dallas、Texas、美国
- Texas Oncology- Medical City
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El Paso、Texas、美国
- Texas Oncology
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Fort Worth、Texas、美国
- The Center for Cancer and Blood Disorders
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Houston、Texas、美国
- Texas Oncology-Houston Memorial City
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Houston、Texas、美国
- The University of Texas- MD Anderson Cancer Center
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San Antonio、Texas、美国
- Cancer Care Centers of South Texas
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Tyler、Texas、美国
- Texas Oncology
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Utah
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Salt Lake City、Utah、美国
- Huntsman Cancer Institute
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Virginia
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Norfolk、Virginia、美国
- Virginia Oncology Associate
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Washington
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Issaquah、Washington、美国
- Swedish Medical Center
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Tacoma、Washington、美国
- Northwest Medical Specialties
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Barcelona、西班牙
- Hospital Universitario Vall d'Hebron
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Cordoba、西班牙
- Hospital Universitario Reina Sofia
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Cáceres、西班牙
- Hospital San Pedro De Alcantara
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Lleida、西班牙
- Hospital Universitario Arnau de Vilanova
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Madrid、西班牙
- Hospital General Universitario Gregorio Marañón
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Madrid、西班牙
- Hospital Clinico San Carlos
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Madrid、西班牙
- Hospital Universitario Ramon y Cajal
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Palma de Mallorca、西班牙
- H.U.Son Espases
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Pamplona、西班牙
- Hospital de Navarra
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Sevilla、西班牙
- Hospital Universitario Virgen De La Macarena
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MM-302 + trastuzumab
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其他名称：
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有源比较器：Chemotherapy of Physician's Choice plus trastuzumab
Chemotherapy limited to one of the following: Gemcitabine, Capecitabine or Vinorelbine
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其他名称：
其他名称：
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
大体时间：Approximately 2 years
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Approximately 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
大体时间：Approximately 2 years
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Approximately 2 years
|
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Overall Survival
大体时间：Approximately 3 years
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Approximately 3 years
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Time to Treatment Failure
大体时间：Approximately 2 years
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Approximately 2 years
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Objective Response Rate based on independent and investigator review of tumor assessments
大体时间：Approximately 2 years
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Approximately 2 years
|
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Duration of Response (DoR) based on independent and investigator review of tumor assessments
大体时间：Approximately 2 years
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Approximately 2 years
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Safety
大体时间：Approximately 2 years
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We will look specifically at the Number of Participants with Adverse Events related to MM-302 as compared to the control arm
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Approximately 2 years
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Pharmacokinetic exposure of MM-302
大体时间：Approximately 2 years
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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.
|
Approximately 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年7月1日
初级完成 (实际的)
2016年12月1日
研究完成 (预期的)
2017年6月1日
研究注册日期
首次提交
2014年8月6日
首先提交符合 QC 标准的
2014年8月7日
首次发布 (估计)
2014年8月11日
研究记录更新
最后更新发布 (估计)
2017年1月6日
上次提交的符合 QC 标准的更新
2017年1月4日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.