Spots Global Cancer Trial Database for A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
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Trial Identification
Brief Title: A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Official Title: Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)
Study ID: NCT03975647
Conditions
Study Description
Brief Summary: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Detailed Description: This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in participants with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab treatment is permitted, but not required. Participants will be randomized in a 1:1 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1. While on study treatment, participants will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama - Mitchell Cancer Institute, Mobile, Alabama, United States
Ironwood Cancer & Research Centers - Chandler, Chandler, Arizona, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Cancer Treatment Centers of America / Western Regional Medical Center, Goodyear, Arizona, United States
Arizona Oncology Associates, PC - HAL, Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
St. Bernards Medical Center, Jonesboro, Arkansas, United States
City of Hope National Medical Center, Duarte, California, United States
California Cancer Associates for Research and Excellence Inc (cCARE), Encinitas, California, United States
St. Joseph Heritage Healthcare TRIO, Fullerton, California, United States
Chao Family Comprehensive Cancer Center University of California Irvine, Orange, California, United States
University of California Irvine - Newport, Orange, California, United States
University of California Davis, Sacramento, California, United States
San Francisco General Hospital, San Francisco, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies, San Francisco, California, United States
UCLA Department of Medicine - Hematology & Oncology, Santa Monica, California, United States
Torrance Memorial Physician Network - TRIO, Torrance, California, United States
Kaiser Permanente Medical Center Northern California, Vallejo, California, United States
Rocky Mountain Cancer Centers - Aurora, Aurora, Colorado, United States
University of Colorado Hospital / University of Colorado, Aurora, Colorado, United States
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado, Broomfield, Colorado, United States
University of Colorado Health Memorial Hospital, Colorado Springs, Colorado, United States
Cancer Centers of Colorado - Denver, Denver, Colorado, United States
Poudre Valley Health System (PVHS), Fort Collins, Colorado, United States
Helen F. Graham Cancer Center / Christiana Care Health Systems, Newark, Delaware, United States
Lombardi Cancer Center / Georgetown University Medical Center, Washington, District of Columbia, United States
Florida Cancer Specialists - South Region, Fort Myers, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
AdventHealth Cancer Institute, Orlando, Florida, United States
Orlando Health, Inc. TRIO, Orlando, Florida, United States
Florida Cancer Specialists - North Region, Saint Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Florida Cancer Specialists - East West Palm Beach, FL (SCRI), West Palm Beach, Florida, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
Augusta University, Augusta, Georgia, United States
Northside Hospital, Canton, Georgia, United States
Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States
Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii, United States
Illinois Cancer Specialists - Arlington Heights, Arlington Heights, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Illinois Cancer Care, Peoria, Illinois, United States
Ft Wayne Medical Oncology and Hematology, Inc TRIO, Fort Wayne, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
CHI Saint Joseph Medical Group Cancer Care Center, Lexington, Kentucky, United States
Ochsner Medical Center, New Orleans, Louisiana, United States
University of Maryland, Baltimore, Maryland, United States
Mercy Medical Center -Weinberg Center, Baltimore, Maryland, United States
American Oncology Networks LLC, Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A., Rockville, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Minnesota Oncology Hematology P.A., Minneapolis, Minnesota, United States
North Mississippi Medical Center Hematology Oncology - Tupelo, Tupelo, Mississippi, United States
Saint Luke's Cancer Institute LLC, Kansas City, Missouri, United States
HCA Midwest Health Kansas City, Kansas City, Missouri, United States
Washington University in St Louis, Saint Louis, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Summit Medical Group, Florham Park, New Jersey, United States
Saint Barnabas Medical Center Cancer Center, Livingston, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Northwest Cancer Specialists, P.C., Tigard, Oregon, United States
University of Pennsylvania / Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America / Eastern Regional Medical Center, Philadelphia, Pennsylvania, United States
Brig Center for Cancer Care and Survivorship, Knoxville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - Amarillo, Amarillo, Texas, United States
Texas Oncology - Austin Central, Austin, Texas, United States
Texas Oncology - DFW, Bedford, Texas, United States
Texas Oncology - DFW, Dallas, Texas, United States
Texas Oncology - Medical City Dallas, Dallas, Texas, United States
Texas Oncology - DFW, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The Center for Cancer and Blood Disorders: Fortworth, Fort Worth, Texas, United States
Texas Oncology - Houston Memorial City, Houston, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Baylor Clinic, Houston, Texas, United States
Oncology Consultants, PA, Houston, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Saint Francis Hospital / Bon Secours - Virginia, Midlothian, Virginia, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care, Salem, Virginia, United States
Swedish Cancer Institute - Edmonds, Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah, Issaquah, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Peter MacCallum Cancer Centre, Melbourne, Other, Australia
Austin Health, Melbourne, Other, Australia
Breast Cancer Research Centre, Nedlands, Other, Australia
Mater Hospital, Sydney, Other, Australia
Westmead Hospital, Westmead, Other, Australia
LKH- Universitat Klinikum Graz, Graz, Other, Austria
Medizinische Universitat Innsbruck, Innsbruck, Other, Austria
LKH Salzburg, Universitatsklinikum der PMU, Salzburg, Other, Austria
Medizinische Universitat Wien, Vienna, Other, Austria
Klinik Ottakring, Vienna, Other, Austria
Institut Jules Bordet, Anderlecht, Other, Belgium
Cliniques Universitaires Saint Luc, Brussels, Other, Belgium
Grand Hôpital de Charleroi - Saint-Joseph, Charleroi, Other, Belgium
Universitair Ziekenhuis Antwerpen, Edegem, Other, Belgium
Academisch Ziekenhuis Groeninge, Kortrijk, Other, Belgium
CHU de Liege, Liege, Other, Belgium
Universitair Ziekenhuis Leuven, Lueven, Other, Belgium
CHU UCL Namur-Site de Saint Elisabeth, Namur, Other, Belgium
University of Alberta / Cross Cancer Institute, Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
Cancer Centre of Southeastern Ontario At Kingston General Hospital, Kingston, Ontario, Canada
London Health Sciences Centre - Victoria Hospital, London, Ontario, Canada
University of Ottawa / Ottawa General Hospital, Ottawa, Ontario, Canada
University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval, Quebec, , Canada
Cancer Hospital Chinese Academy of Medical Sciences, Beijing City, Other, China
Peking University People's Hospital, Beijing, Other, China
Jilin Province Cancer Hospital, Changghun, Other, China
Hunan Cancer Hospital, Changsha, Other, China
Sun Yat-sen University Cancer Center, Guangzhou City, Other, China
Guangdong Provincial People's Hospital, Guangzhou, Other, China
Zhejiang Cancer Hospital, Hangzhou City, Other, China
First Affiliated Hospital of Zhejiang University, Hangzhou City, Other, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Other, China
Shandong Cancer Hospital, Jinan, Other, China
Gulou Hospital Affiliated to Nanjing University Medical College, Nanjing, Other, China
Shengjing Hospital of China Medical University, Shenyang City, Other, China
Tianjin Medical University - Cancer Institute & Hospital, Tianjin, Other, China
Hubei Cancer Hospital, Wuhan, Other, China
Wuhan University, Wuhan, Other, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Other, China
Xi'An International Medical Center Hospital, Xi'An, Other, China
Xuzhou Central Hospital, Xuzhou, Other, China
The Affiliated Hospital of Xuzhou Medical College, Xuzhou, Other, China
The Affiliated Hospital of Guangdong Medical University, Zhan Jiang City, Other, China
Henan Cancer Hospital, Zhengzhou, Other, China
Zigong First People's Hospital, Zigong City, Other, China
Bejing Hospital, Bejing, , China
Center of Women and Children Hospital of Guangdong Province, Guangzhou, , China
Nanchang Third Hospital, Nanchang City, , China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, , China
Aalborg Universitetshospital, Aalborg, Other, Denmark
Aarhus University Hospital, Aarhus N, Other, Denmark
Rigs Hospiltalet, Copenhagen, Other, Denmark
Herlev Hospital, Herlev, Other, Denmark
Odense University Hospital, Odense C, Other, Denmark
Sygehus Lillebaelt - Vejle Sygehus, Vejle, Other, Denmark
University Hospital of Besancon, Besancon cedex, Other, France
Hospital Center Regional University Morvan De Brest, Brest, Other, France
Centre de Lutte contre le Cancer - Francois Baclesse, Caen Cedex 5, Other, France
Hopital Europeen Georges Pompidou, Cedex 15, Other, France
Center Georges Francois Leclerc, Dijon, Other, France
Clinique Victor Hugo Le Mans, Le Mans, Other, France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes, Lyon cedex 08, Other, France
Institut Paoli Calmettes, Marseille, Other, France
Hopital Saint-Louis / Service d'Hematologie, Paris Cedex 10, Other, France
Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris, Paris, Other, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer, Rouen, Other, France
Hopitaux Universitaires de Strasbourg, Strasbourg, Other, France
Institut Claudius Regaud IUCT-O, Toulouse Cedex 9, Other, France
CHU Tours - Hopital Bretonneau, TOURS Cedex 09, Other, France
Helios Klinikum Berlin-Buch, Berlin, Other, Germany
Stadtisches Klinikum Dessau, Dessau-Rosslau, Other, Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung, Essen, Other, Germany
CHOP GmbH, Frankfurt, Other, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE), Hamburg, Other, Germany
Universitatsklinikum Heidelberg, Heidelberg, Other, Germany
Universitatsklinikum Schleswig-Holstein, Kiel, Other, Germany
InVO- Institut fUr Versorgungsforschung in der onkologie GbR, Koblenz, Other, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, Other, Germany
Klinikum Rechts der Isar der Technischen Universitaet Muenchen, Muenchen, Other, Germany
Klinikum der Universitat Munchen, Munchen, Other, Germany
Sana Klinikum Offenbach GmbH, Offenbach am Main, Other, Germany
University of Rostock, Rostock, Other, Germany
Shaare Zedek Medical Center, Jerusalem, Other, Israel
Meir Medical Center, Kfar Saba, Other, Israel
Rabin Medical Center, Petach Tikva, Other, Israel
Kaplan Medical Center, Rehovot, Other, Israel
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, Other, Italy
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo FPO - IRCCS, Candiolo, Other, Italy
Irccs Irst, Meldola, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Seconda Università degli Studi di Napoli, AOU, Napoli, Other, Italy
Nuovo Ospedale di Prato - Santo Stefano, Prato, Other, Italy
Ospedale degli Infermi, Rimini, Other, Italy
Policlinico Universitario Agostino Gemelli, Roma, Other, Italy
Azienda Ospedaliera S. Maria di Terni, Terni, Other, Italy
A.O.U. - Ospedali Riuniti di Ancona, Torrette, Other, Italy
Chiba Cancer Center, Chiba, Other, Japan
National Cancer Center Hospital, Chuo-ku, Other, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, Other, Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Other, Japan
University of Tsukuba Hospital, Ibaraki, Other, Japan
Hakuaikai Sagara Hospital/Breast Surgery, Kagosima, Other, Japan
Kameda General Hospital, Kamogawa, Other, Japan
National Cancer Center Hospital East, Kashiwa-shi, Other, Japan
Saitama Cancer Center, Kitaadachi-gun, Other, Japan
Kumamoto Shinto General Hospital, Kumamoto, Other, Japan
NHO Shikoku Cancer Center, Matsuyama, Other, Japan
Aichi Cancer Center, Nagoya-shi, Other, Japan
Hyogo College of Medicine Hospital, Nishinomiya, Other, Japan
National Hospital Organization Osaka, Osaka, Other, Japan
Osaka International Cancer Institute, Osaka, Other, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Other, Japan
Shizuoka Cancer Center, Sunto-Gun, Other, Japan
The Cancer Institute Hospital of JFCR, Tokyo, Other, Japan
Kanagawa Cancer Center, Yokohama, Other, Japan
National Cancer Center, Goyang-si, Other, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Other, Korea, Republic of
Korea University Anam Hospital, Seoul, Other, Korea, Republic of
Seoul National University Hospital, Seoul, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Other, Korea, Republic of
Asan Medical Center - Oncology, Seoul, Other, Korea, Republic of
Samsung Medical Center, Seoul, Other, Korea, Republic of
Isala Ziekenhuis Zwolle, AB Zwolle, Other, Netherlands
Netherlands Cancer Institute, Amsterdam, Other, Netherlands
Amphia Ziekenhuis, Breda, Other, Netherlands
Reinier de Graaf Hospital, Delft, Other, Netherlands
University Medical Center Groningen, Groningen, Other, Netherlands
Martini Ziekenhuis, Groningen, Other, Netherlands
Maastricht University Medical Center, Maastricht, Other, Netherlands
Erasmus Medisch Centrum Daniel Den Hoed, Rotterdam, Other, Netherlands
National University Cancer Institute, Singapore, Singapore, Other, Singapore
National Cancer Centre Singapore, Singapore, Other, Singapore
Hospital del Mar, Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
Hospital Universitario Reina Sofia, Cordoba, Other, Spain
Hospital General Universitario Gregorio Marañon, Madrid, Other, Spain
Hospital Ruber Internacional, Madrid, Other, Spain
Hospital Clinico San Carlos, Madrid, Other, Spain
Hospital Universitario HM Sanchinarro, Madrid, Other, Spain
Hospital Universitario Virgen de la Victoria, Malaga, Other, Spain
Hospital Universitario Son Espases, Palma de Mallorca, Other, Spain
L'Institut Catala d'Oncologia, Saint Joan Despi, Other, Spain
Hospital Universitario de Canarias, San Cristóbal de la Laguna, Other, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Other, Spain
Hospital Clinico Universitario de Valencia, Valencia, Other, Spain
Hospital Universitario Miguel Servet, Zaragoza, Other, Spain
Goteborgs Universitet - Sahlgrenska Akademin - Institutionen For Kliniska Vetenskaper (Institute Of Clinical Sciences), Gothenburg, Other, Sweden
Ryhov Hospital, Jonkoping, Other, Sweden
Skanes University Hospital - Universitetssjukhus, Lund, Other, Sweden
Orebro University Hospital, Orebro, Other, Sweden
Onkologklinike Sodersjukhuset, Stockholm, Other, Sweden
University Hospital Basel - Brustzentrum, Basel, Other, Switzerland
Institute of Oncology of Southern Switzerland, Bellinzona, Other, Switzerland
University Hospital Lausanne CHUV, Lausanne, Other, Switzerland
Kantonsspital Winterthur (KSW), Winterthur, Other, Switzerland
National Cheng-Kung University Hospital, Tainan, Other, Taiwan
National Taiwan University Hospital, Tainan, Other, Taiwan
University Hospitals Birmingham NHS Foundation Trust, Birmingham, Other, United Kingdom
Addenbrooke's Hospital, Cambridge, Other, United Kingdom
The University of Edinburgh, Edinburgh, Other, United Kingdom
Oxford University Hospitals, Headington, Other, United Kingdom
The Royal Marsden NHS Foundation Trust (RM), London, Other, United Kingdom
Sarah Cannon Research Institute UK, London, Other, United Kingdom
Maidstone and Tunbridge Wells NHS Trust, Maidstone, Other, United Kingdom
The Christie NHS Foundation Trust, Manchester, Other, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, Other, United Kingdom
Mount Vernon Hospital, UK, Northwood, Other, United Kingdom
The Royal Marsden Hospital (Surrey), Sutton, Other, United Kingdom
Royal Cornwall Hospitals NHS Trust, Truro, Other, United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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