Clinical trial NCT03975647: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HER2-positive Breast Cancer
Keywords: Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: * Inclusion Criteria:

  * Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory
  * History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
  * Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy
  * Measurable or non-measurable disease assessable by RECIST v1.1
  * ECOG performance status score of 0 or 1
  * CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following:

    (a) No evidence of brain metastases

    (b) Untreated brain metastases not needing immediate local therapy

    (c) Previously treated brain metastases
    1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
    2. Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met:

       (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days.

       (ii) Other sites of evaluable disease are present
    3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
* Exclusion Criteria:

  * Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity).
  * CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following:

    1. Any untreated brain lesions \>2 cm in size
    2. Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of \>2 mg of dexamethasone (or equivalent).
    3. Any brain lesion thought to require immediate local therapy
    4. Known or concurrent leptomeningeal disease as documented by the investigator
    5. Poorly controlled generalized or complex partial seizures

Primary outcomes:
measure: Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment
timeFrame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
measure: Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment
timeFrame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months)
measure: Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment
timeFrame: From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months)
measure: Overall Survival in Participants With Brain Metastases at Baseline
timeFrame: Up to approximately 5 years
measure: Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR)
timeFrame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
measure: Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR
timeFrame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
measure: Objective Response Rate as Per RECIST v1.1 Determined by BICR
timeFrame: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
measure: Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment
timeFrame: Up to approximately 5 years
measure: Duration of Response as Per RECIST v1.1 by BICR
timeFrame: Up to approximately 5 years
measure: Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment
timeFrame: Up to approximately 5 years
measure: Clinical Benefit Rate as Per RECIST v1.1 by BICR
timeFrame: Up to approximately 5 years
measure: Number of Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama - Mitchell Cancer Institute
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers - Chandler
state: Arizona
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America / Western Regional Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Encinitas
country: United States
facility: California Cancer Associates for Research and Excellence Inc (cCARE)
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare TRIO
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center University of California Irvine
state: California
city: Orange
country: United States
facility: University of California Irvine - Newport
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
state: California
city: Santa Monica
country: United States
facility: UCLA Department of Medicine - Hematology & Oncology
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network - TRIO
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center Northern California
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital / University of Colorado
state: Colorado
city: Broomfield
country: United States
facility: SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: University of Colorado Health Memorial Hospital
state: Colorado
city: Denver
country: United States
facility: Cancer Centers of Colorado - Denver
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Health System (PVHS)
state: Colorado
city: Newark
country: United States
facility: Helen F. Graham Cancer Center / Christiana Care Health Systems
state: Delaware
city: Washington
country: United States
facility: Lombardi Cancer Center / Georgetown University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South Region
state: Florida
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
city: Orlando
country: United States
facility: AdventHealth Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc. TRIO
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North Region
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute / Emory University School of Medicine
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Canton
country: United States
facility: Northside Hospital
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women and Children
state: Hawaii
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists - Arlington Heights
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Fort Wayne
country: United States
facility: Ft Wayne Medical Oncology and Hematology, Inc TRIO
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: CHI Saint Joseph Medical Group Cancer Care Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center -Weinberg Center
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Networks LLC
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center Hematology Oncology - Tupelo
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute LLC
state: Missouri
city: Kansas City
country: United States
facility: HCA Midwest Health Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center Cancer Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania / Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America / Eastern Regional Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Brig Center for Cancer Care and Survivorship
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology - Amarillo
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Austin Central
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders: Fortworth
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Houston Memorial City
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Houston
country: United States
facility: Baylor Clinic
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, PA
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Midlothian
country: United States
facility: Saint Francis Hospital / Bon Secours - Virginia
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
state: Virginia
city: Edmonds
country: United States
facility: Swedish Cancer Institute - Edmonds
state: Washington
city: Issaquah
country: United States
facility: Swedish Cancer Institute - Issaquah
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Other
city: Melbourne
country: Australia
facility: Austin Health
state: Other
city: Nedlands
country: Australia
facility: Breast Cancer Research Centre
state: Other
city: Sydney
country: Australia
facility: Mater Hospital
state: Other
city: Westmead
country: Australia
facility: Westmead Hospital
state: Other
city: Graz
country: Austria
facility: LKH- Universitat Klinikum Graz
state: Other
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
state: Other
city: Salzburg
country: Austria
facility: LKH Salzburg, Universitatsklinikum der PMU
state: Other
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
state: Other
city: Vienna
country: Austria
facility: Klinik Ottakring
state: Other
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
state: Other
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
state: Other
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Saint-Joseph
state: Other
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Other
city: Kortrijk
country: Belgium
facility: Academisch Ziekenhuis Groeninge
state: Other
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
state: Other
city: Liege
country: Belgium
facility: CHU de Liege
state: Other
city: Namur
country: Belgium
facility: CHU UCL Namur-Site de Saint Elisabeth
state: Other
city: Edmonton
country: Canada
facility: University of Alberta / Cross Cancer Institute
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario At Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa / Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval
city: Beijing City
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Other
city: Beijing
country: China
facility: Peking University People's Hospital
state: Other
city: Changghun
country: China
facility: Jilin Province Cancer Hospital
state: Other
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Other
city: Guangzhou City
country: China
facility: Sun Yat-sen University Cancer Center
state: Other
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Other
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital
state: Other
city: Hangzhou City
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Other
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Other
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Other
city: Nanjing
country: China
facility: Gulou Hospital Affiliated to Nanjing University Medical College
state: Other
city: Shenyang City
country: China
facility: Shengjing Hospital of China Medical University
state: Other
city: Tianjin
country: China
facility: Tianjin Medical University - Cancer Institute & Hospital
state: Other
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Other
city: Wuhan
country: China
facility: Wuhan University
state: Other
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Other
city: Xi'An
country: China
facility: Xi'An International Medical Center Hospital
state: Other
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Other
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Other
city: Zhan Jiang City
country: China
facility: The Affiliated Hospital of Guangdong Medical University
state: Other
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Other
city: Zigong City
country: China
facility: Zigong First People's Hospital
state: Other
city: Bejing
country: China
facility: Bejing Hospital
city: Guangzhou
country: China
facility: Center of Women and Children Hospital of Guangdong Province
city: Nanchang City
country: China
facility: Nanchang Third Hospital
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: Other
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Other
city: Copenhagen
country: Denmark
facility: Rigs Hospiltalet
state: Other
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Other
city: Odense C
country: Denmark
facility: Odense University Hospital
state: Other
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt - Vejle Sygehus
state: Other
city: Besancon cedex
country: France
facility: University Hospital of Besancon
state: Other
city: Brest
country: France
facility: Hospital Center Regional University Morvan De Brest
state: Other
city: Caen Cedex 5
country: France
facility: Centre de Lutte contre le Cancer - Francois Baclesse
state: Other
city: Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
state: Other
city: Dijon
country: France
facility: Center Georges Francois Leclerc
state: Other
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Other
city: Lyon cedex 08
country: France
facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
state: Other
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Other
city: Paris Cedex 10
country: France
facility: Hopital Saint-Louis / Service d'Hematologie
state: Other
city: Paris
country: France
facility: Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris
state: Other
city: Rouen
country: France
facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
state: Other
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
state: Other
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud IUCT-O
state: Other
city: TOURS Cedex 09
country: France
facility: CHU Tours - Hopital Bretonneau
state: Other
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
state: Other
city: Dessau-Rosslau
country: Germany
facility: Stadtisches Klinikum Dessau
state: Other
city: Essen
country: Germany
facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
state: Other
city: Frankfurt
country: Germany
facility: CHOP GmbH
state: Other
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf (UKE)
state: Other
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
state: Other
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Other
city: Koblenz
country: Germany
facility: InVO- Institut fUr Versorgungsforschung in der onkologie GbR
state: Other
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Other
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar der Technischen Universitaet Muenchen
state: Other
city: Munchen
country: Germany
facility: Klinikum der Universitat Munchen
state: Other
city: Offenbach am Main
country: Germany
facility: Sana Klinikum Offenbach GmbH
state: Other
city: Rostock
country: Germany
facility: University of Rostock
state: Other
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Other
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: Other
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
state: Other
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: Other
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
state: Other
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo FPO - IRCCS
state: Other
city: Meldola
country: Italy
facility: Irccs Irst
state: Other
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: Other
city: Napoli
country: Italy
facility: Seconda Università degli Studi di Napoli, AOU
state: Other
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato - Santo Stefano
state: Other
city: Rimini
country: Italy
facility: Ospedale degli Infermi
state: Other
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Other
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria di Terni
state: Other
city: Torrette
country: Italy
facility: A.O.U. - Ospedali Riuniti di Ancona
state: Other
city: Chiba
country: Japan
facility: Chiba Cancer Center
state: Other
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Other
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Other
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
state: Other
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
state: Other
city: Kagosima
country: Japan
facility: Hakuaikai Sagara Hospital/Breast Surgery
state: Other
city: Kamogawa
country: Japan
facility: Kameda General Hospital
state: Other
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Other
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Other
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
state: Other
city: Matsuyama
country: Japan
facility: NHO Shikoku Cancer Center
state: Other
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Other
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
state: Other
city: Osaka
country: Japan
facility: National Hospital Organization Osaka
state: Other
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
state: Other
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Other
city: Sunto-Gun
country: Japan
facility: Shizuoka Cancer Center
state: Other
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Other
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Other
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Other
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Other
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Other
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Other
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Other
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - Oncology
state: Other
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Other
city: AB Zwolle
country: Netherlands
facility: Isala Ziekenhuis Zwolle
state: Other
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Other
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Other
city: Delft
country: Netherlands
facility: Reinier de Graaf Hospital
state: Other
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
state: Other
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
state: Other
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Other
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum Daniel Den Hoed
state: Other
city: Singapore
country: Singapore
facility: National University Cancer Institute, Singapore
state: Other
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
state: Other
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Other
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Other
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Other
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
state: Other
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
state: Other
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Other
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
state: Other
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Other
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Other
city: Saint Joan Despi
country: Spain
facility: L'Institut Catala d'Oncologia
state: Other
city: San Cristóbal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Other
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Other
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Other
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Other
city: Gothenburg
country: Sweden
facility: Goteborgs Universitet - Sahlgrenska Akademin - Institutionen For Kliniska Vetenskaper (Institute Of Clinical Sciences)
state: Other
city: Jonkoping
country: Sweden
facility: Ryhov Hospital
state: Other
city: Lund
country: Sweden
facility: Skanes University Hospital - Universitetssjukhus
state: Other
city: Orebro
country: Sweden
facility: Orebro University Hospital
state: Other
city: Stockholm
country: Sweden
facility: Onkologklinike Sodersjukhuset
state: Other
city: Basel
country: Switzerland
facility: University Hospital Basel - Brustzentrum
state: Other
city: Bellinzona
country: Switzerland
facility: Institute of Oncology of Southern Switzerland
state: Other
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne CHUV
state: Other
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur (KSW)
state: Other
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
state: Other
city: Tainan
country: Taiwan
facility: National Taiwan University Hospital
state: Other
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: Other
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Other
city: Edinburgh
country: United Kingdom
facility: The University of Edinburgh
state: Other
city: Headington
country: United Kingdom
facility: Oxford University Hospitals
state: Other
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (RM)
state: Other
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: Other
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
state: Other
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Other
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
state: Other
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital, UK
state: Other
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital (Surrey)
state: Other
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
state: Other
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: