Clinical trial NCT05132582: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Official title: A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HER2 Positive Breast Cancer
Keywords: HER2+ breast cancer
Breast Cancer
Metastatic breast cancer
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 654
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 works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.

All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Detailed description: Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days

Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days

Trastuzumab and pertuzumab will be administered as follows:

• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.

AND

* Pertuzumab will be given IV at 420 mg every 21 days. OR
* Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.

Eligibility criteria: Inclusion Criteria:

* Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH).
* Have unresectable locally advanced or metastatic disease.

  * If recurrent (after \[neo\]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
* Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
* Known hormone receptor status (per local guidelines; may be hormone receptor positive \[HR+\] or negative \[HR-\])
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:

  * No evidence of brain metastases
  * Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
  * Previously treated brain metastases which are asymptomatic

    * Brain metastases previously treated with local therapy must not have progressed since treatment

Exclusion Criteria:

* Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
* Unable to undergo contrast-enhanced MRI of the brain
* CNS Exclusion - Based on screening brain MRI and clinical assessment

  * Symptomatic brain metastasis after CNS-directed local therapy
  * Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
  * Ongoing use of systemic corticosteroids at a total daily dose of \>2 mg of dexamethasone (or equivalent)
  * Any untreated brain lesion in an anatomic site which may pose risk to participant
  * Known or suspected leptomeningeal disease (LMD)
  * Poorly controlled (\>1/week) seizures, or other persistent neurologic symptoms

Primary outcomes:
measure: Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 5 years
measure: PFS by blinded independent central review (BICR) per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Time to deterioration of health-related quality of life (HRQoL)
timeFrame: Up to approximately 3 years
measure: Central nervous system (CNS) PFS
timeFrame: Up to approximately 3 years
measure: Incidence of adverse events (AEs)
timeFrame: Through 30 days after last study treatment, approximately 18 months
measure: Incidence of laboratory abnormalities
timeFrame: Through 30 days after last study treatment, approximately 18 months
measure: Incidence of tucatinib dose alterations
timeFrame: Through 30 days after last study treatment, approximately 18 months
measure: Incidence of trastuzumab dose alterations
timeFrame: Through 30 days after last study treatment, approximately 18 months
measure: Incidence of pertuzumab dose alterations
timeFrame: Through 30 days after last study treatment, approximately 18 months
measure: Maximum concentration (Cmax)
timeFrame: Through 30 days after last study treatment, approximately 18 months
measure: Trough concentration (Ctrough)
timeFrame: Through 30 days after last study treatment, approximately 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Little Rock
country: United States
facility: CARTI Cancer Center,Central Arkansas Radiation Therapy Institute
state: Arkansas
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Beverly Hills
country: United States
facility: UCLA Hematology/Oncology - Beverly Hills
state: California
city: Burbank
country: United States
facility: UCLA Hematology/Oncology - Burbank
state: California
city: Encinitas
country: United States
facility: UCSD Medical Center - Encinitas
state: California
city: La Jolla
country: United States
facility: Koman Family Outpatient Pavilion
state: California
city: La Jolla
country: United States
facility: Sulpizio Cardiovascular Center at UC San Diego Health
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
state: California
city: La Jolla
country: United States
facility: UCSD Perlman Medical Offices
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Laguna Hills
country: United States
facility: UCLA Hematology/Oncology - Laguna Hills
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center - Hillcrest
state: California
city: San Luis Obispo
country: United States
facility: UCLA Hematology/Oncology - San Luis Obispo
state: California
city: Santa Barbara
country: United States
facility: UCLA Hematology/Oncology- Santa Barbara
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology Parkside
state: California
city: Torrance
country: United States
facility: Clinical And Translational Research Center
state: California
city: Torrance
country: United States
facility: Investigational Drug Service
state: California
city: Torrance
country: United States
facility: Lundquist Institute/Harbor-UCLA
state: California
city: Torrance
country: United States
facility: The Lundquist Institute for Biomedical Innovation at H arbor-UCLA M edical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Valencia
country: United States
facility: UCLA Hematology/Oncology - Santa Clarita
state: California
city: Vista
country: United States
facility: UCSD Medical Center - Vista
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology/Oncology- Westlake
state: California
city: Altamonte Springs
country: United States
facility: AdventHealth Altamonte Infusion Center
state: Florida
city: Altamonte Springs
country: United States
facility: AdventHealth Medical Group Altamonte(second location)
state: Florida
city: Altamonte Springs
country: United States
facility: AdventHealth Medical Group Altamonte
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Medical Group Orlando
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando Infusion Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Systems
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute - Downtown
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: Brownsboro Diagnostic Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, St Matthews Campus
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, St. Matthews Campus
state: Kentucky
city: Louisville
country: United States
facility: Norton Diagnostic Center - Dupont
state: Kentucky
city: Louisville
country: United States
facility: Norton Women's & Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Brownsboro Hospital Campus
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Louisville
country: United States
facility: Norton Diagnostic Center - Fern Creek
state: Kentucky
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Cancer Institute.
state: Missouri
city: Grand Island
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Grand Island
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Papillion
country: United States
facility: Oncology Hematology West PC dba Nebraska Cancer Specialists
state: Nebraska
city: Jersey City
country: United States
facility: RWJBarnabas Health- Jersey City Medical Center
state: New Jersey
city: Lakewood
country: United States
facility: RWJBarnabas Health- Monmouth Medical Center-Southern Campus
state: New Jersey
city: Livingston
country: United States
facility: RWJBarnabas Health- Cooperman Barnabas Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: RWJBarnabas Health- Monmouth Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Somerville
country: United States
facility: RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
state: New Jersey
city: Somerville
country: United States
facility: Steeplechase Cancer Center
state: New Jersey
city: Toms River
country: United States
facility: RWJBarnabas Health - Community Medical Center
state: New Jersey
city: West Long Branch
country: United States
facility: Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Einstein Comprehensive Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Strongsville
country: United States
facility: Cleveland Clinic Cancer Center - Strongsville
state: Ohio
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Shelbyville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital/Medical College of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University Clinical Trials Unit.
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Old Tonggabbie
country: Australia
facility: Baxter Healthcare Pty Limited
state: New South Wales
city: Sydney
country: Australia
facility: Pharmacy Macquarie University Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Western Sydney Local Health District (WSLHD), Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
city: Adelaide
country: Australia
facility: HPS Pharmacies -Adelaide (South Tee) (lnvestigational Product storage and dispensing)
state: South Australia
city: Adelaide
country: Australia
facility: St Andrews Medical Centre
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
state: Washington
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Schwaz
country: Austria
facility: Ordination Priv.-Doz. Dr. Michael Hubalek
state: Other
city: Graz
country: Austria
facility: Anstaltsapotheke des Landeskrankenhauses
city: Graz
country: Austria
facility: Medizinische Universitat Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Schwaz
country: Austria
facility: Marien Apotheke Schwaz
city: Wien
country: Austria
facility: Anstaltsapotheke des Allgemeinen Krankenhauses der Stadt Wien
city: Wien
country: Austria
facility: Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
state: Brussels
city: Bruxelles-Capitale
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Oost-vlaanderen
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
state: Walloon Brabant
city: Anderlecht
country: Belgium
facility: Jules Bordet lnstituut
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussels
country: Belgium
facility: UCL Saint-Luc
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel (UZ Brussel)
city: Ottignies
country: Belgium
facility: Clinique St Pierre
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia
state: Ceara
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional lntegrado de Oncologia
state: Ceara
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goias
city: Bela Vista
country: Brazil
facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda.
state: Other
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
state: Other
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
state: Other
city: Londrina
country: Brazil
facility: Hospital Do Cancer De Londrina
state: Parana
city: Natal
country: Brazil
facility: Liga Norte-Rio Grandense Contra o Cancer
state: RIO Grande DO Norte
city: Natal
country: Brazil
facility: Liga Norte-Rio-Grandense Contra o Cancer
state: RIO Grande DO Norte
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos - Fundacao Pio XII
state: SAO Paulo
city: Barretos
country: Brazil
facility: Fundacao Pio XII, Hospital do Amor de Barretos
state: SAO Paulo
city: Jau
country: Brazil
facility: Fundacao Dr Amaral Carvalho
state: SAO Paulo
city: Jaú
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
state: SAO Paulo
city: Santo Andre
country: Brazil
facility: CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
state: SAO Paulo
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
state: SAO Paulo
city: Sao Jose Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: SAO Paulo
city: Porto Alegre/RS
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
city: Sao Jose do Rio Preto
country: Brazil
facility: Faculdade Regional de Medicina de Sao Jose do Rio Preto
city: Sao Paulo
country: Brazil
facility: ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente (AC Camargo Cancer Center)
city: Sao Paulo
country: Brazil
facility: Sao Camilo Oncologia
city: Sao Paulo
country: Brazil
facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
city: São Paulo/SP
country: Brazil
facility: A.C. Camargo Câncer Center
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital - Toronto
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Motreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Limitada
state: Cautin
city: Recoleta
country: Chile
facility: Centro de Investigacion Clínica Bradford Hill
state: Santiago
city: Viña del Mar
country: Chile
facility: Oncocentro Apys
state: Valparaíso
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica Bradford Hill
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule
city: Temuco
country: Chile
facility: James Lind Centro De Investigacion Del Cancer
city: Hefei City
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital - Guangdong Province
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
state: Guangxi
city: Haikou
country: China
facility: The first Affiliated Hospital of Hainan Medical University
state: Hainan
city: Baoding City
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Zhengzhou City
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan City
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing City
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang City
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang City
country: China
facility: Liaoning Cancer Hospital & Insitute
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
state: Other
city: Shanghai
country: China
facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine
state: Other
city: Xi'an City
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Linyi City
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Binjiang District
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Nanjing
country: China
facility: Nanjing Medical University (NMU) - Jiangsu Province Hospital
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Tianjin City
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Praha
country: Czechia
facility: Lekarna Vseobecne fakultni nemocnice v Praze
state: Praha 2
city: Brno
country: Czechia
facility: Masarykuv Onkologicky Ustav
city: Brno
country: Czechia
facility: Ustavni lekarna Masarykuv onkologicky ustav
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4 - Krc
country: Czechia
facility: Lekarna FTN
city: Praha 4 - Krc
country: Czechia
facility: Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
city: Praha 5 - Motol
country: Czechia
facility: Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
city: Tampere
country: Finland
facility: Tampere University Hospital pharmacy
city: Tampere
country: Finland
facility: Tampere University Hospital, FONK/RSYO
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Rouen
country: France
facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
state: Bretagne
city: Bordeaux
country: France
facility: Institut Bergonie
state: Cedex
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
state: Languedoc-roussillon
city: Saint Herblain
country: France
facility: Institut de Cancerologie de lOuest-Saint Herblain
state: Loire-atlantique
city: Nice Cedex 2
country: France
facility: Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
state: Lyon
city: Saint Herblain cedex
country: France
facility: Institut de Cancerologie de lOuest - Site Rene Gauducheau
state: Mainet-et-loire
city: Avignon Cedex 9
country: France
facility: Institut Sainte-Catherine.
city: Besancon
country: France
facility: CHU Besancon - Pole Pharmaceutique - Unite essais cliniques
city: Besangon
country: France
facility: CHU Besancon
city: Bobigny
country: France
facility: Centre Hospitalier Universitaire Hopital Avicenne
city: Bobigny
country: France
facility: Hopital Avicenne
city: Caen Cedex 5
country: France
facility: Centre de Lutte contre le Cancer - François Baclesse
city: Caen
country: France
facility: CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Pharmacy
city: Dijon
country: France
facility: Center Georges-Francois Leclerc
city: Lille
country: France
facility: Centre de Lutte contre le Cancer (CLCC) - Centre Oscar Lambret
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Center Leon Berard
city: Montpellier Cedex 5
country: France
facility: Institut Régional du Cancer de Montpellier
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier Service lmagerie medicale
city: Montpellier
country: France
facility: lnstitut Regional du Cancer de Montpellier- Service Pharmacie
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Pharmacy :Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie - site de Paris - Pharmacy
city: Paris
country: France
facility: Institut Curie - site de Paris, Unitéd Investigation Clinique
city: Pierre Benite
country: France
facility: Hopitaux Civils de Lyon
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon
city: Plerin
country: France
facility: "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
city: Rennes
country: France
facility: Centre Eugene Marquis Pharmacie - Essais Cliniques
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Institut Curie - site St-Cloud
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
city: Strasbourg
country: France
facility: Centre Paul Strauss Pharmacie - Essais cliniques
city: Saint-Cloud
country: France
facility: Institut Curie
state: Île-de-france
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf (UKE)
state: North Rhine-westphalia
city: Mannheim
country: Germany
facility: Pharmacy:Fortuna Herstellung GmbH
state: Other
city: Augsburg
country: Germany
facility: "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
city: Berlin
country: Germany
facility: Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
city: Hamburg
country: Germany
facility: "Pharmacy: Universitatsklinikum Hamburg-Eppendorf Apotheke (Gebaude N19)"
city: Manheim
country: Germany
facility: Universitätsmedizin Mannheim Universitätsfrauenklinik
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar der Technischen Universitaet Muenchen
city: Munster
country: Germany
facility: University Hospital Muenster Senology
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
city: Ulm
country: Germany
facility: Apotheke des Universitatsklinikums Ulm
city: Wurzburg
country: Germany
facility: Universitatsklinikum Wurzburg Apotheke
city: Wurzburg
country: Germany
facility: Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
city: Wurzburg
country: Germany
facility: Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
city: Athens
country: Greece
facility: General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
state: Attica
city: Patra
country: Greece
facility: University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
state: Peloponnese
city: Larissa
country: Greece
facility: University General Hospital of Larissa, Oncology Clinic
city: Maroussi
country: Greece
facility: IASO
city: Pireaus
country: Greece
facility: Metaxa Anticancer Hospital of Piraeus
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria (AOU) Federico II
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
state: Campania
city: Napoli
country: Italy
facility: lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
state: Campania
city: Genova
country: Italy
facility: Farmacia centrale
state: Liguria
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico, San Martino
state: Liguria
city: Rozzano (Milano)
country: Italy
facility: Istituto Clinico Humanitas-Humanitas Cancer Center
state: Lombardia
city: Monza (MB)
country: Italy
facility: ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
state: Lombardy
city: Torrette
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
state: Marche
city: Monza
country: Italy
facility: U.O. Farmacia Asst Monza
state: Monza AND Brianza
city: Catania (CT)
country: Italy
facility: Humanitas lstituto Clinico Catanese
state: Sicily
city: Trento
country: Italy
facility: Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
state: Trentino
city: Trento
country: Italy
facility: SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
state: Trentino
city: Livorno
country: Italy
facility: Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
state: Tuscany
city: Prato
country: Italy
facility: S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
state: Tuscany
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
city: Bologna
country: Italy
facility: SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Divisione di Senologia Medica; Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: Farmacia Istituto Clinico Humanitas
city: Parma
country: Italy
facility: UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
city: Kamogawa-shi
country: Japan
facility: Tesshokai Kameda General Hospital
state: Chiba-ken
city: Kamogawa
country: Japan
facility: Medical Corporation Tesshokai Kameda Medical Center
state: Chiba
city: Kashiwa-Shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Shikoku Cancer Center
state: Ehime-ken
city: Matsuyama
country: Japan
facility: NHO Shikoku Cancer Center
state: Ehime
city: Fukuoka-city
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital
state: Lbaraki-ken
city: Naha-shi
country: Japan
facility: Naha Nishi Clinic
state: Okinawa-ken
city: Naha-shi
country: Japan
facility: Medical Corporation Nahanishikai Nahanishi Clinic
state: Okinawa
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka-fu
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo-to
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital.
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk Nationl University Hospital
state: Chungcheongbuk-do
city: Wonju-si
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Gangwon-do
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Goyang-Si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital, The Catholic University of Korea
state: Gyeonggido [kyonggi-do]
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Doedrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid-holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Utrecht
country: Netherlands
facility: St. Antonius Hospital
city: Venlo
country: Netherlands
facility: VieCuri Medsich Centrum
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: Opole
country: Poland
facility: SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
city: Gliwice
country: Poland
facility: Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
state: Śląskie
city: Braga
country: Portugal
facility: Centro Clinico Academico Braga Hospital de Braga
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Lisbon
country: Portugal
facility: Champalimaud Clinical Center
city: Lisbon
country: Portugal
facility: The Champalimaud Centre for the Unknown
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante
state: Comunidad Valenciana
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: EI Palmar
country: Spain
facility: Hospital Universitario Virgen De La Arrixaca
state: Murcia
city: La Laguna Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Santa CRUZ DE Tenerife
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Girona
country: Spain
facility: Institut Catala d'Oncologia Girona - ICO Girona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca (Spain Salamanca)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Fundacion lnstituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
city: Baden
country: Switzerland
facility: Kantonsspital Baden.
city: Zürich
country: Switzerland
facility: Brust-Zentrum AG
city: Changhua City
country: Taiwan
facility: Changhua Christian Medical Foundation Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital LinKou
city: London
country: United Kingdom
facility: Academic Oncology
state: England
city: Sutton
country: United Kingdom
facility: The Royal Marsden
state: Surrey
city: London
country: United Kingdom
facility: Finchley Memorial Hospital
city: London
country: United Kingdom
facility: University College London Hospital (UCLH) NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (RM)
city: London
country: United Kingdom
facility: The Royal Marsden
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: