Clinical trial NCT01942135: Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
Official title: MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Keywords: Palbociclib (PD-0332991)
Fulvestrant
Goserelin
Hormone receptor-+
HER2-negative
Prior Endocrine treatment
any menopausal status
PALOMA-3
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2013-09-13
Enrollment: 521
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 a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).


Eligibility criteria: Inclusion Criteria:

* Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
* Confirmed diagnosis of HR+/HER2- breast cancer
* Any menopausal status
* Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
* On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
* Measurable disease defined by RECIST version 1.1, or bone-only disease
* Eastern Cooperative Oncology Group (ECOG) PS 0-1
* Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
* Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

* Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
* Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
* Major surgery or any anti-cancer therapy within 2 weeks of randomization
* Prior stem cell or bone marrow transplantation
* Use of potent CYP3A4 inhibitors or inducers

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 (assessed up to 12 months)
Secondary outcomes:
measure: Overall Survival (OS)-Number of Participants Who Died
timeFrame: From randomization until death (up to 4.5 years)
measure: Overall Survival (OS)
timeFrame: From randomization until death (up to 4.5 years)
measure: Survival Probabilities at Year 1, Year 2, and Year 3
timeFrame: From randomization until death (assessed up to 36 months)
measure: Objective Response (OR)
timeFrame: From randomization until end of treatment (assessed up to 2 years)
measure: Duration of Response (DR)
timeFrame: From randomization until end of treatment (assessed up to 2 years)
measure: Clinical Benefit Response (CBR)
timeFrame: From randomization until end of treatment (assessed up to 2 years)
measure: Observed Plasma Trough Concentration (Ctrough) for Palbociclib
timeFrame: Cycle 1/Day 15 and Cycle 2/Day 15
measure: Ctrough for Fulvestrant
timeFrame: Cycles 2/Day 1 and Cycle 3/Day 1
measure: Ctrough for Goserelin
timeFrame: Cycles 2/ Day 1 and Cycle 3/ Day 1
measure: Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
timeFrame: From Cycle 1 to 14, as of 05 December 2014.
measure: Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores
timeFrame: From Cycle 1 to 14, as of 05 December 2014.
measure: Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
timeFrame: From Cycle 1 to 14, as of 05 December 2014.
measure: Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores
timeFrame: From Cycle 1 to 14, as of 05 December 2014.
measure: Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores
timeFrame: From Cycle 1 to 14, as of 05 December 2014.
measure: Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale
timeFrame: From Cycle 1 to 14, as of 05 December 2014.
measure: Time to Deterioration (TTD)
timeFrame: Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment, as of 05 December 2014
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)
timeFrame: From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
measure: Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results
timeFrame: From baseline to end of treatment/withdrawal (up to 4.5 years)
measure: Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Chemistry Results
timeFrame: From baseline to end of treatment/withdrawal (up to 4.5 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, The Kirklin Clinic
state: Alabama
city: Birmingham
country: United States
facility: UAB Hospital-Investigational Drug Service
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Daphne
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center,PC
state: Alabama
city: Avondale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Chandler
country: United States
facility: Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
state: Arizona
city: Flagstaff
country: United States
facility: Arizona Oncology Associates, PC- HAL
state: Arizona
city: Gilbert
country: United States
facility: Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
state: Arizona
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology
state: Arizona
city: Glendale
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Goodyear
country: United States
facility: Western Regional Medical Center, Inc.
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
state: Arizona
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates, PC- HAL
state: Arizona
city: Sedona
country: United States
facility: Arizona Oncology Associates, PC- HAL
state: Arizona
city: Surprise
country: United States
facility: Arizona Center for Cancer Care
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center- North Campus
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
state: California
city: Culver City
country: United States
facility: Administrative Management Only: Translational Research Management
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center-La Jolla
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC & USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology Oncology
state: California
city: Orange
country: United States
facility: Breastlink Medical Group, Inc.
state: California
city: Orange
country: United States
facility: Hematology Oncology Medical Group of Orange County, Inc. (HOMG)
state: California
city: Orange
country: United States
facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
state: California
city: Pasadena
country: United States
facility: UCLA Hematology/Oncology - Pasadena
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center-Hillcrest
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco: Helen Diller 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 Ana
country: United States
facility: Breastlink Medical Group, Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: South Pasadena
country: United States
facility: City of Hope
state: California
city: Torrance
country: United States
facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network-Cancer Care
state: California
city: West Hills
country: United States
facility: Wellness Oncology & Hematology
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology - Oncology Clinic - Westlake Village
state: California
city: Aurora
country: United States
facility: ATTN - Research Pharmacist
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
state: Colorado
city: Aventura
country: United States
facility: Mount Sinai Medical Center- Aventura
state: Florida
city: Deerfield Beach
country: United States
facility: Sylvester Comprehensive Cancer Center Deerfield Beach
state: Florida
city: Deerfield Beach
country: United States
facility: University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center
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: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospitals & Clinics
state: Florida
city: Ocoee
country: United States
facility: Orlando Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
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 at Plantation
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Austell
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
state: Georgia
city: Cartersville
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Zion
country: United States
facility: Cancer Treatment Centers of America at Midwestern Regional Medical Center
state: Illinois
city: Brunswick
country: United States
facility: Maine Center for Cancer Medicine, dba: New England Cancer Specialists
state: Maine
city: Kennebunk
country: United States
facility: Maine Center for Cancer Medicine, dba: New England Cancer Specialists
state: Maine
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine, dba: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
state: Maryland
city: Lutherville
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System/Comprehensive Cancer Center
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Edina
country: United States
facility: Fairview Southdale Oncology Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Physicians, Masonic Cancer Center
state: Minnesota
city: Ballwin
country: United States
facility: Mercy Clinic St. Louis Cancer and Breast Institute
state: Missouri
city: Chesterfield
country: United States
facility: Mercy Ministry Office
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
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St.Louis- David C. Pratt Cancer Center
state: Missouri
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: 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: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Brewster
country: United States
facility: CareMount Medical
state: New York
city: Lake Success
country: United States
facility: ProHEALTHCARE Associates, LLP
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: Asheville
country: United States
facility: Hope Women's Cancer Centers
state: North Carolina
city: Asheville
country: United States
facility: Mission Hospital, Inc.
state: North Carolina
city: Monroeville
country: United States
facility: UPMC Cancer Center, Monroeville
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology- Dallas Presbyterian Hospital
state: Texas
city: Fort Worth
country: United States
facility: Investigational Products Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Irving
country: United States
facility: US Oncology lnvestigational Products Center (IPC)
state: Texas
city: Longview
country: United States
facility: Texas Oncology- Longview Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology- McAllen South Second Street
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Tyler
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology- Weslaco
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Arlington
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center
state: Virginia
city: Fairfax
country: United States
facility: Inova Medical Group
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Leesburg
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology, P.C.
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center First Hill IDS Pharmacy
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Mequon
country: United States
facility: Columbia St. Mary's
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's
state: Wisconsin
city: Bankstown
country: Australia
facility: Bankstown - Lidcombe Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Auchenflower
country: Australia
facility: River City Pharmacy
state: Queensland
city: Nambour
country: Australia
facility: Sunshine Coast Hospital and Health Service
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Care Southport
state: Queensland
city: Brighton
country: Australia
facility: Cabrini Brighton
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Frankston
country: Australia
facility: Peninsula and Southeast Oncology
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health, University Hospital Geelong
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre Pharmacy
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital Clinical Trials Pharmacy
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital - Cancer Centre
state: Western Australia
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre
state: Brabant Wallon
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
state: Bruxelles Capitale
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Site Notre Dame
state: Hainaut
city: Haine St. Paul
country: Belgium
facility: INDC Entité Jolimontoise - CH de Jolimont-Lobbes
state: Hainaut
city: Tournai
country: Belgium
facility: CHWaPi - Site IMC
state: Hainaut
city: Libramont-Chevigny
country: Belgium
facility: C.H. de l'Ardenne - site Libramont
state: Luxembourg
city: Bruxelles
country: Belgium
facility: Hopital Erasme
state: Region DE Bruxelles-capital
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Namur
country: Belgium
facility: CHU UCL Namur - Site Sainte-Elisabeth
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen - Campus St Augustinus
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: British Columbia Cancer Agency - Fraser Valley Centre
state: British Columbia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre, General Campus
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System Walker Family Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig AoeR
city: Leipzig
country: Germany
facility: Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz
city: München
country: Germany
facility: Klinikum der Universität München
city: München
country: Germany
facility: Klinikum der Universität München
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Bagno A Ripoli (FI)
country: Italy
facility: Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna
city: Bagno A Ripoli (FI)
country: Italy
facility: S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata
city: Bologna
country: Italy
facility: SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi
city: Catania
country: Italy
facility: U.O. di Oncologia Medica P.O. Policlinico G. Rodolico"
city: Legnago (VR)
country: Italy
facility: Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis
city: Legnago (VR)
country: Italy
facility: Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago
city: Meldola (FC)
country: Italy
facility: IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Farmacia IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: IRCCS Ospedale S. Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Servizio di Farmacia - Istituto Europeo di Oncologia
city: Modena
country: Italy
facility: Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Roma
country: Italy
facility: Farmacia - Fondazione Policlinico Universitario A. Gemelli
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Terni
country: Italy
facility: S.C. Oncologia, A.O.S. Maria
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: Kita-adachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama,japan
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kagoshima
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
city: Osaka
country: Japan
facility: National Hospital Organization
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: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
state: Limburg
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medisch Centrum
state: Limburg
city: Tilburg
country: Netherlands
facility: TweeSteden Ziekenhuis
state: Noord-brabant
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
state: Zuid-holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-holland
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
state: Zuid-holland
city: Lisboa
country: Portugal
facility: Champalimaud Cancer Center/ Breast Unit
city: Porto
country: Portugal
facility: Instituto Português de Oncologia
city: Bucharest
country: Romania
facility: Spitalul Clinic CF nr.2 Bucuresti
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
city: Tg. Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Belgorod,
country: Russian Federation
facility: OGBUZ Belgorod Oncology Dispensary
state: Belgorodskaya Oblast',
city: Stariy Oskol
country: Russian Federation
facility: OGBUZ Belgorod Oncology Dispensary
state: Belgorodskaya Oblast'
city: Village Kuzmolovsky
country: Russian Federation
facility: GBUZ Leningrad regional oncological dispensary
state: Leningradskaya Oblast'
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
state: Republic OF Bashkortostan
city: Lermontov
country: Russian Federation
facility: FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
state: Stavropol Territory
city: Pyatigorsk,
country: Russian Federation
facility: GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
state: Stavropol Territory
city: Chelyabinsk
country: Russian Federation
facility: GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
city: Moscow
country: Russian Federation
facility: FSBSI Russian Cancer Research Center n.a.NN Blokhin
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg GBUZ City Clinical Oncology Dispensary
city: Stavropol
country: Russian Federation
facility: GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
city: Village Pesochny
country: Russian Federation
facility: FGBU Russian Research Center for Radiology and Surgical Technologies
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
state: Bornova
city: Chernivtsi
country: Ukraine
facility: Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr"
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,
city: Kharkiv
country: Ukraine
facility: Komunalne nekomertsiyne pidpryiemstvo "Oblasnyi
city: Lviv
country: Ukraine
facility: KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi
city: Odesa
country: Ukraine
facility: Komunalna ustanova "Odeska oblasna klinichna likarnia"
city: Vinnytsia
country: Ukraine
facility: Podilskyi rehionalnyi tsentr onkolohii,
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre
state: Hampshire
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
state: South Glamorgan
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital
state: South Yorkshire
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
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