Clinical trial NCT01740427: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
Official title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: breast cancer
postmenopausal women
estrogen-receptor positive
HER2 negative
locoregionally recurrent
metastatic
Palbociclib (PD-0332991)
PALOMA-2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 666
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


Eligibility criteria: Inclusion Criteria:

* Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Confirmed diagnosis of ER positive breast cancer
* No prior systemic anti-cancer therapy for advanced ER+ disease.
* Postmenopausal women
* Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease
* Eastern Cooperative Oncology Group \[ECOG\] 0-2
* Adequate organ and marrow function
* Patient must agree to provide tumor tissue

Exclusion Criteria:

* Confirmed diagnosis of HER2 positive disease
* Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
* Known uncontrolled or symptomatic CNS metastases
* Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
* Prior treatment with any CDK 4/6 inhibitor.

Primary outcomes:
measure: Progression-Free Survival (PFS) as Assessed by the Investigator
timeFrame: From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)
Secondary outcomes:
measure: Objective Response as Assessed by the Investigator
timeFrame: From randomization until end of treatment (up to approximately 2.5 years)
measure: Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator
timeFrame: From randomization until end of treatment (up to approximately 2.5 years)
measure: Duration of Response (DR)
timeFrame: From randomization until end of treatment (up to approximately 2.5 years)
measure: Disease Control (DC)/Clinical Benefit Response (CBR)
timeFrame: From randomization until end of treatment (up to approximately 2.5 years)
measure: PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
timeFrame: From randomization until end of treatment (up to approximately 24 Months)
measure: Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14
timeFrame: Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
measure: Percentage of Participants With Corrected QT Interval (QTc)
timeFrame: For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)
measure: Observed Plasma Trough Concentration (Ctrough) at Steady-State
timeFrame: 0 hour (predose) on Day 14 of cycles 1 and 2
measure: Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
timeFrame: From Baseline up to 2.5 years
measure: Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: From Baseline up to 2.5 years
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities
timeFrame: From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)
measure: Overall Survival (OS): Primary Analysis
timeFrame: From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)
measure: Overall Survival (OS): Final Analysis
timeFrame: From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)
measure: Survival Probability at 1 Year, 2 Year and 3 Year
timeFrame: 1, 2 and 3 years after randomization
measure: Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade
timeFrame: From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Glendale
country: United States
facility: Los Angeles Hematology/Oncology Medical Group
state: California
city: Irvine
country: United States
facility: UCLA Hematology/ Oncology- Irvine
state: California
city: Laguna Hills
country: United States
facility: UCLA Hematology Oncology- Laguna Hills
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology/Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Translational Research Management
state: California
city: Los Angeles
country: United States
facility: Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy: Drug Management Only
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy; Drug Management Only
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy
state: California
city: Los Angeles
country: United States
facility: Administrative Address: UCLA Hematology/Oncology
state: California
city: Los Angeles
country: United States
facility: Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: Regulatory Management Only: TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: TRIO-US Central Administration: Regulatory Management Only
state: California
city: Los Angeles
country: United States
facility: TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Pasadena
country: United States
facility: UCLA Hematology/ Oncology- Pasadena
state: California
city: Redondo Beach
country: United States
facility: Torrance Health Association, DBa Torrance Memorial Physician Network
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
state: California
city: San Luis Obispo
country: United States
facility: San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Medical Center and Orthopaedic Hospital
state: California
city: Stanford
country: United States
facility: Stanford Women's Cancer Center
state: California
city: West Hills
country: United States
facility: Wellness Oncology & Hematology
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology/Oncology- Westlake
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Norwalk
country: United States
facility: Whittingham Cancer Center @ Norwalk Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Deerfield Beach
country: United States
facility: Sylvester at Deerfield Beach
state: Florida
city: Hollywood
country: United States
facility: Memorial Breast Cancer Center at Memorial Regional Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute at Memorial Regional Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialist of North Florida, Pharmacy
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida-Southpoint
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Breast Cancer Center at Memorial Hospital West
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial Hospital West
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Plantation
country: United States
facility: Sylvester Comprehensive Cancer Center Plantation
state: Florida
city: Saint Augustine
country: United States
facility: Cancer Specialists of North Florida - St. Augustine
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Clinic Cancer Services
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Clinic Cancer Services
state: Idaho
city: Chicago
country: United States
facility: The Mark M. Connolly Center for Cancer and Specialty Care
state: Illinois
city: Danville
country: United States
facility: Carle Foundation Hospital DBA Carle Cancer Center
state: Illinois
city: Effingham
country: United States
facility: Carle Foundation Hospital DBA Carle Cancer Center
state: Illinois
city: Evanston
country: United States
facility: Presence Infusion Care- Evanston
state: Illinois
city: Mattoon
country: United States
facility: Carle Foundation Hospital DBA Carle Cancer Center
state: Illinois
city: Skokie
country: United States
facility: Presence Infusion Care- Skokie
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital DBA Carle Cancer Center
state: Illinois
city: Louisville
country: United States
facility: James Graham Brown Cancer Center and University Hospital
state: Kentucky
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Corinth
country: United States
facility: The West Clinic, PC
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic, PC dba West Cancer Centre
state: Mississippi
city: Ballwin
country: United States
facility: Mercy Clinic St. Louis Cancer and Breast Institute
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Clinic St. Louis Cancer and Breast Institute
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis - David C. Pratt Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Grand Island
country: United States
facility: Saint Francis Medical Center
state: Nebraska
city: Grand Island
country: United States
facility: Saint Francis Medical Center, Saint Francis Cancer Treatment Center
state: Nebraska
city: Hastings
country: United States
facility: Saint Francis Medical Center
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Brewster
country: United States
facility: CareMount Medical
state: New York
city: Mount Kisco
country: United States
facility: CareMount Medical
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University- Cancer Center
state: New York
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest Region
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing 2
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Portland
country: United States
facility: OHSU Research Pharmacy Services
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Germantown
country: United States
facility: The West Clinic, PC dba West Cancer Centre
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, PC dba West Cancer Centre
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Nashville
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: Smyrna
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: El Paso
country: United States
facility: Texas oncology-west Texas
state: Texas
city: El Paso
country: United States
facility: Texas oncology-West Texas
state: Texas
city: El Paso
country: United States
facility: Texas Oncology-west Texas
state: Texas
city: Fort Worth
country: United States
facility: Investigational Products Center (IPC)
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center.
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
state: Virginia
city: Low Moor
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology PC
state: Virginia
city: Wytheville
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists P.C.
state: Washington
city: Morgantown
country: United States
facility: WVU Medicine
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Port Macquarie
country: Australia
facility: Laverty Pathology
state: New South Wales
city: Port Macquarie
country: Australia
facility: Mid North Coast Diagnostic Imaging
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Care
state: Queensland
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care Corporate Office
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bendigo
country: Australia
facility: Bendigo Health Care Group, The Bendigo Hospital Campus
state: Victoria
city: Epping
country: Australia
facility: Northern Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Ringwood East
country: Australia
facility: Maroondah Hospital
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Wilrijk
country: Belgium
facility: Gasthuis Zusters Antwerpen - Campus Sint- Augustinus
state: Antwerpen
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Oncologie
city: Brussel
country: Belgium
facility: UZ Brussel
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi / Service d'Hematologie et Oncologie
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Liege
country: Belgium
facility: CHU Start Tilman
city: Verviers
country: Belgium
facility: CHR East Belgium - Verviers
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Surrey
country: Canada
facility: BC Cancer Agency-Fraser Valley Centre
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency-Vancouver Centre
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre, Victoria General Site
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre- Stronach Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur
state: Quebec
city: Quebec City
country: Canada
facility: Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie
city: Anger Cedex 02
country: France
facility: Institut de Cancerologie de l'Ouest- Paul Papin
city: Caen Cedex 5
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Montpellier CEDEX 5
country: France
facility: Centre Val d'Aurelle,
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Paris Cedex 05
country: France
facility: Institut Curie, Departement d'Oncologie Medicale
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Cloud
country: France
facility: Hopital Rene Huguenin/Institut Curie
city: St Herblain
country: France
facility: Institut de Cancérologie de l'Ouest-Rene Gauducheau
city: Toulouse CEDEX-9
country: France
facility: Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Muenchen
country: Germany
facility: IOZ- Munchen, PGM- Studien GmbH
state: Bavaria
city: Boblingen
country: Germany
facility: Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen, Frauenklinik
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz
city: Muenchen
country: Germany
facility: Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen
city: Munich
country: Germany
facility: Rotkreuzklinikum Munchen, Frauenklinik,
city: Munich
country: Germany
facility: Breast Cancer, University of Munich, Grosshadern Hospital
city: Trier
country: Germany
facility: Klinikum Mutterhaus
city: Budapest
country: Hungary
facility: Szent Margit Korhaz
city: Budapest
country: Hungary
facility: Affidea Diagnosztika Kft.
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ,
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet "B" Belgyogyaszati osztaly
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet, Nuklearis Medicina Osztaly
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily
city: Györ
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Teaching Hospital,
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar
city: Szeged
country: Hungary
facility: Diagnoscan Magyarorszag Kft.
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Dublin 4
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: St. James Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Galway
country: Ireland
facility: Department of Medical Oncology
city: Limerick
country: Ireland
facility: Mid Western Regional Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
state: BO
city: Meldola
country: Italy
facility: Irccs Irst
state: FC
city: Milano
country: Italy
facility: IRCCS - Istituto Europeo di Oncologia
state: Milan
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri
city: Sora (FR)
country: Italy
facility: Ospedale SS Trinita
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-city
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kumamoto-shi
country: Japan
facility: Kumamoto City Hospital
state: Kumamoto
city: Kita-adachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
city: Kagoshima
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital 2-15-3
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Center for Breast Cancer
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock
state: Mazovia
city: Gdańsk
country: Poland
facility: Oncology and Radiotherapy Clinic
city: Zory
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian
city: Kursk
country: Russian Federation
facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical
state: Kursk Region
city: Kuzmolovo
country: Russian Federation
facility: State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"
state: Leningrad Region
city: Kazan
country: Russian Federation
facility: GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan
city: Moscow Area
country: Russian Federation
facility: State Budget Healthcare Institution Moscow City Oncology Hospital
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution
city: Omsk
country: Russian Federation
facility: Budget Institution of Healthcare
city: Omsk
country: Russian Federation
facility: Budget Institution of Healthcare
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Healthcare Institution (SBHCI)
city: St Petersburg
country: Russian Federation
facility: Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways
city: Ufa
country: Russian Federation
facility: Republican Clinical Hospital n.a. G.G. Kuvatov
city: Ufa
country: Russian Federation
facility: State Budget Medical Institution Republican Clinical Oncology
city: Ufa
country: Russian Federation
facility: SBHI of Republic of Bashkortostan Emergency Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Islas Baleares
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion de Alcorcon
state: Madrid
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa CRUZ DE Tenerife
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Donostia- San Sebastian
country: Spain
facility: Hospital de Donostia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: L'Hospitalet De Llobregat (Barcelona)
country: Spain
facility: Instituto Catalan de Oncologia L'Hospitalet
city: La Coruna
country: Spain
facility: Centro Oncologico de Galicia
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional España
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: HOSPITAL Universitario 12 DE OCTUBRE
city: Madrid
country: Spain
facility: Hospital Madrid Universitario Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Veterans General Hospital-Taipei
city: Taipei
country: Taiwan
facility: Mackay Memory Hospital
city: Dnipro
country: Ukraine
facility: MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council
city: Dnipro
country: Ukraine
facility: State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine
city: Kharkiv
country: Ukraine
facility: Municipal Non-profit Enterprise "Regional Centre of Oncology"
city: Lviv
country: Ukraine
facility: Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department
city: Makiivka
country: Ukraine
facility: Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"
city: Sumy
country: Ukraine
facility: Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
city: Uzhgorod
country: Ukraine
facility: City Oncology Centre of Central Municipal Clinical Hospital
city: Uzhgorod
country: Ukraine
facility: Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.
city: Zaporizhzhia
country: Ukraine
facility: MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,
city: Zaporizhzhya
country: Ukraine
facility: State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",
city: Maidstone
country: United Kingdom
facility: Kent Oncology Center
state: Kent
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre, Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Beatson Institute for Cancer Research
state: Scotland
city: London
country: United Kingdom
facility: Guys Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Research And Development Office, The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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