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NCT06105632Active, not recruitingPhase 2

A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: * are 18 years of age or older; * are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; * have advanced or metastatic breast cancer after taking other treatments before this study; * have not taken or need to take medications that are not allowed by the study protocol; * do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: * Fulvestrant alone taken as shot into the muscle. * Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: * imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. * the study doctor thinks the participant is no longer benefitting from the study medicine. * has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. * the participant chooses to stop taking part.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
333 (actual)
First submitted
24 Oct 2023
Start date
9 Jan 2024
Primary completion date
12 Jan 2026
Lead sponsor
Pfizer
NCT number
NCT06105632
EU CT number
2023-506487-13-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 333
  • From 9 Jan 2024 to the primary completion date, 12 Jan 2026
  • 166 sites in 28 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with any of the following:
  • Prior chemotherapy in the advanced setting
  • Radiation within 2 weeks of randomization
  • Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 \[CYP3A4/5\] or uridine 5' diphosphate-glucuronosyltransferase 2B7 \[UGT2B7\] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).

Other illness

  • Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
  • Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
  • Everolimus or investigational anti-cancer agents in any setting

Other

  • In visceral crisis at risk of immediately life-threatening complications in the short term.
  • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Who the study is looking for

  • Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
  • Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor
  • Documented HER2-negative tumor
  • Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
  • Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
  • Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (166)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIPREC
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Buenos AiresArgentinaUnknown status
Clínica Universitaria Reina Fabiola
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CórdobaArgentinaUnknown status
Instituto de Oncología de Rosario
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RosarioArgentinaUnknown status
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
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San Miguel de TucumánArgentinaUnknown status
Clinica Viedma S.A.
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ViedmaArgentinaUnknown status
Icon Cancer Centre Townsville
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RossleaAustraliaUnknown status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumCompleted
Institut Jules Bordet
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AnderlechtBelgiumCompleted
Algemeen Ziekenhuis klina
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BrasschaatBelgiumCompleted
Cliniques universitaires Saint-Luc
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BrusselsBelgiumCompleted
Grand Hopital de Charleroi
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CharleroiBelgiumCompleted
Ziekenhuis Oost-Limburg
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GenkBelgiumCompleted
Az Maria Middelares Gent
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GentBelgiumCompleted
AZ Sint-Lucas & Volkskliniek
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GentBelgiumCompleted
Centre Hospitalier D`Ardenne - Forget
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LibramontBelgiumCompleted
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumCompleted
Algemeen Ziekenhuis Damiaan Oostende
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OstendBelgiumCompleted
Clinique Saint Pierre
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Ottignies-Louvain-la-NeuveBelgiumCompleted
AZ Delta vzw
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RoeselareBelgiumCompleted
AZ Turnhout
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TurnhoutBelgiumCompleted
Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
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GabrovoBulgariaCompleted
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
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HaskovoBulgariaCompleted
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaCompleted
Complex Oncological Center - Plovdiv, EOOD
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PlovdivBulgariaCompleted
Complex Oncological Center - Shumen EOOD
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ShumenBulgariaCompleted
Mbal Za Zhensko Zdrave Nadezhda OOD
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SofiaBulgariaCompleted
Complex Oncology Center Vratsa EOOD
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VratsaBulgariaCompleted
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco
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RecifeBrazilUnknown status
Royal Victoria Regional Health Centre
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BarrieCanadaUnknown status
CIUSSS- saguenay-Lac-Saint-Jean
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ChicoutimiCanadaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
Fakultni nemocnice v Motole
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PragueCzechiaCompleted
Fakultni nemocnice Bulovka
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PragueCzechiaCompleted
Fakultni Thomayerova nemocnice
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Prague 4CzechiaCompleted
Klinikum Aschaffenburg-Alzenau gGmbH
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AschaffenburgGermanyCompleted
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyCompleted
Haematologisch-Onkologische Praxis Eppendorf (HOPE)
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HamburgGermanyCompleted
Institut fuer Versorgungsforschung in der Onkologie GbR
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KoblenzGermanyCompleted
Universitaetsklinikum Muenster AöR
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MuensterGermanyCompleted
Klinikum Ernst von Bergmann gGmbH
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PotsdamGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Region Hovedstaden
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HerlevDenmarkCompleted
Region Midtjylland
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HerningDenmarkCompleted
Sygehus Soenderjylland Soenderborg
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SoenderborgDenmarkCompleted
Institut Catala d'Oncologia
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BadalonaSpainCompleted
Hospital Universitario de Cruces
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BarakaldoSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitario Clínico San Cecilio
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GranadaSpainCompleted
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainCompleted
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Salut Sant Joan de Reus
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ReusSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainCompleted
Universidade De Santiago De Compostela
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Santiago De CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Quironsalud Valencia
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ValenciaSpainCompleted
Fundación Instituto Valenciano de Oncología
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ValenciaSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
HUS-Yhtymae
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HelsinkiFinlandCompleted
Kuopio University Hospital
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KuopioFinlandCompleted
Tampere University Hospital
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TampereFinlandCompleted
Institut de Cancerologie de L'Ouest
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AngersFranceCompleted
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Polyclinique Bordeaux Nord Aquitaine
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Bordeaux CedexFranceCompleted
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceCompleted
Centre Jean Perrin
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Clermont Ferrand Cedex1FranceCompleted
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceCompleted
Centre Hospitalier Departemental Vendee
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La Roche Sur Yon Cedex 9FranceCompleted
Centre Oscar Lambret
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LilleFranceCompleted
Institut Curie
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ParisFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Hôpital Privé des Côtes d'Armor
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PlérinFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Henri Becquerel
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RouenFranceCompleted
Institut Curie
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Saint-CloudFranceCompleted
Institut De Cancerologie De L Ouest
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St HerblainFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Sarah Cannon Research Institute UK
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LondonUnited KingdomUnknown status
Imperial College Healthcare NHS Trust, Charing Cross Hospital
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LondonUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceCompleted
St Savas Hospital
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AthensGreeceCompleted
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Bioclinic S.A.
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ThessalonikiGreeceCompleted
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz
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BudapestHungaryCompleted
Orszagos Onkologiai Intezet
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Budapest XIIHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryCompleted
Nograd Varmegyei Szent Lazar Korhaz
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SalgótarjánHungaryCompleted
Tolna Varmegyei Balassa Janos Korhaz
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SzekszárdHungaryCompleted
Zala Varmegyei Szent Rafael Korhaz
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ZalaegerszegHungaryCompleted
Rambam Health Care Campus
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Rajiv Gandhi Cancer Institute And Research Centre
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New DelhiIndiaUnknown status
Sahyadri Super Speciality Hospital
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PuneIndiaUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
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LeghornItalyCompleted
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyCompleted
IRCCS - Ospedale San Raffaele
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MilanoItalyCompleted
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyCompleted
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Chiba Cancer Center
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ChibaJapanUnknown status
St. Luke's International Hospital
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Chuo-kuJapanUnknown status
Hiroshima City Hiroshima Citizens Hospital
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HiroshimaJapanUnknown status
National Hospital Organization Osaka National Hospital
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OsakaJapanUnknown status
Gunma Prefectural Cancer Center
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OtashiJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Osaka University Hospital
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SuitaJapanUnknown status
Gangnam Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
COI Centro Oncologico Internacional S.A.P.I. de C.V.
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Mexico CityMexicoUnknown status
Filios Alta Medicina S.A. de C.V.
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MonterreyMexicoUnknown status
Oaxaca Site Management Organization S.C.
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Oaxaca CityMexicoUnknown status
Instituto Veracruzano en Investigación Clínica S.C.
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VeracruzMexicoUnknown status
Jagiellonskie Centrum Innowacji Sp. z o.o.
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CracowPolandCompleted
Szpitale Pomorskie Sp z o o
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GdyniaPolandCompleted
Przychodnia Lekarska "KOMED"
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KoninPolandCompleted
Pleszewskie Centrum Medyczne W Pleszewie Sp. z o.o.
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PleszewPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Mazowiecki Szpital Onkologiczny Sp. z o.o.
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WieliszewPolandCompleted
Region Joenkoepings Laen
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JonkopingSwedenCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Region Oerebro Laen
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OrebroSwedenCompleted
Soedersjukhuset AB
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StockholmSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
Västmanlands Sjukhus Västerås
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VästeråsSwedenCompleted
Medeon s.r.o.
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BankaSlovakiaCompleted
Narodny onkologicky ustav
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BratislavaSlovakiaCompleted
Nemocnica AGEL Komarno s.r.o.
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KomarnoSlovakiaCompleted
Vychodoslovensky Onkologicky Ustav a.s.
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KošiceSlovakiaCompleted
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
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MichalovceSlovakiaCompleted
Fakultna Nemocnica Nitra
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NitraSlovakiaCompleted
Fakultna nemocnica s poliklinikou Nove Zamky
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Nové ZámkySlovakiaCompleted
Fakultna nemocnica Trencin
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TrenčínSlovakiaCompleted
Fakultna nemocnica Trnava
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TrnavaSlovakiaCompleted
Fakultna nemocnica s poliklinikou Zilina
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ŽilinaSlovakiaCompleted
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
Intermountain Health St. Vincent Regional Hospital
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BillingsUnited StatesUnknown status
Memorial Hermann Cancer Center
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HoustonUnited StatesUnknown status
Hoag Health Center Irvine
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IrvineUnited StatesUnknown status
Hoag Hospital Irvine
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IrvineUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Keck Hospital of USC
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Los AngelesUnited StatesUnknown status
Los Angeles General Medical Center
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Los AngelesUnited StatesUnknown status
Hoag Memorial Hospital Presbyterian
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Newport BeachUnited StatesUnknown status
MedStar Washington Hospital Center
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Washington D.C.United StatesUnknown status
Gulhane Egitim Arastirma Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Ultramar Medical Imaging Center
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AnkaraTurkey (Türkiye)Unknown status
Medipol Mega Universite Hastanesi
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StanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.