A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Inavolisib; Drug: Placebo; Drug: Palbociclib; Drug: Fulvestrant

• Registration Number: NCT04191499
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or wit...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-09
• Study Start: 2020-01-29
• Primary Completion: 2023-09-29
• Status Verified: 2024-09
• Results First Submitted: 2024-09-17
• Results First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Results First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inavolisib + Palbociclib + Fulvestrant	Inavolisib	Participants will receive inavolisib, palbociclib, and fulvestrant.
Inavolisib + Palbociclib + Fulvestrant	Palbociclib	Participants will receive inavolisib, palbociclib, and fulvestrant.
Inavolisib + Palbociclib + Fulvestrant	Fulvestrant	Participants will receive inavolisib, palbociclib, and fulvestrant.
Placebo + Palbociclib + Fulvestrant	Placebo	Participants will receive placebo, palbociclib, and fulvestrant.
Placebo + Palbociclib + Fulvestrant	Palbociclib	Participants will receive placebo, palbociclib, and fulvestrant.
Placebo + Palbociclib + Fulvestrant	Fulvestrant	Participants will receive placebo, palbociclib, and fulvestrant.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 3.7 years	PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target les...

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response Rate (ORR)	Up to approximately 6 years	ORR is defined as the percentage of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reductio...
Percentage of Participants With Best Overall Response Rate (BOR)	Up to approximately 6 years	BOR is defined as the percentage of participants with a CR or PR, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of t...
Duration of Response (DOR)	Up to approximately 6 years	DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). CR is defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reducti...
Percentage of Participants With Clinical Benefit Rate (CBR)	Up to approximately 6 years	CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1. CR= disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR=at least a 30% decrease in the sum ...
Overall Survival (OS)	Up to approximately 6 years	OS is defined as the time from randomization to death from any cause.
Time to Deterioration (TTD) in Pain	From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years)	TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and ...
TTD in Physical Function (PF)	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]	TTD in physical function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 ...
TTD in Role Function (RF)	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]	TTD in Role Function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-C30 RF scale (items 6 and 7). A ≥10-point change is defined as clinically me...
TTD in Global Health Status (GHS)	Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)]	TTD in (GHS)/health-related quality of life (HRQoL) is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-30 GHS/HRQoL scale. A ≥10-point change is def...
Number of Participants With Adverse Events (AEs)	Up to approximately 6 years	An AE is an untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered relate...
Plasma Concentration of Inavolisib	Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Plasma Concentration of Palbociclib	Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
Plasma Concentration of Fulvestrant	Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)

Trial Locations

Locations (158)

Clinica Universitaria de Navarra; Servicio de Oncologia; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario de Canarias;servicio de Oncologia; 🇪🇸 La Laguna, Tenerife, Spain

Hospital del Mar; Servicio de Oncologia; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department; 🇪🇸 Barcelona, Spain

Insituto Catalán de Oncologia (ICO); 🇪🇸 Barcelona, Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia; 🇪🇸 Jaen, Spain

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia; 🇪🇸 Madrid, Spain

Clinica Universidad de Navarra-Madrid; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; Servicio de Oncologia; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; Servicio de Oncologia; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen Macarena; Servicio de Oncologia; 🇪🇸 Sevilla, Spain

Instituto Valenciano Oncologia; Oncologia Medica; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia; 🇪🇸 Valencia, Spain

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery; 🇨🇳 Kaohsiung, Taiwan

Chi-Mei Medical Centre; Hematology & Oncology; 🇨🇳 Tainan, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology; 🇨🇳 Taipei City, Taiwan

VETERANS GENERAL HOSPITAL; Department of General Surgery; 🇨🇳 Taipei, Taiwan

National Taiwan Uni Hospital; General Surgery; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital, Division of General Surgery; 🇨🇳 Taipei, Taiwan

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc; 🇹🇭 Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial; 🇹🇭 Chiang Mai, Thailand

Chulabhorn Hospital; Medical Oncology; 🇹🇭 Lak Si, Thailand

Songklanagarind Hospital; Department of Oncology; 🇹🇭 Songkhla, Thailand

Adana Baskent University Hospital; Medical Oncology; 🇹🇷 Adana, Turkey

Gulhane Training and Research Hospital; 🇹🇷 Ankara, Turkey

Ege University Medical Faculty; Medical Oncology Department; 🇹🇷 Bornova, ?zm?r, Turkey

Istanbul University Cerrahpasa Faculty of Medicine; 🇹🇷 Istanbul, Turkey

Prof. Dr. Cemil Tascioglu City Hospital; Med Onc; 🇹🇷 Istanbul, Turkey

Uzhhorod Central City Clinical Hospital; 🇺🇦 Uzhhorod, KIEV Governorate, Ukraine

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department; 🇺🇦 Kharkiv, Kharkiv Governorate, Ukraine

Texas Oncology - Central South; 🇺🇸 Austin, Texas, United States

Beverly Hills Cancer Center; 🇺🇸 Beverly Hills, California, United States

Hopital du Saint Sacrement; 🇨🇦 Quebec City, Quebec, Canada

Beijing Cancer Hospital; 🇨🇳 Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun City, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

The First Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou City, China

Sun Yet-sen University Cancer Center; 🇨🇳 Guangzhou City, China

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department; 🇨🇳 Hangzhou City, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University); 🇨🇳 Nanjing City, China

Fudan University Shanghai Cancer Center; Medical Oncology; 🇨🇳 Shanghai City, China

Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province); 🇨🇳 Shijiazhuang, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan City, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China

Vejle Sygehus; Onkologisk Afdeling; 🇩🇰 Vejle, Denmark

Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne; 🇫🇷 Clermont-ferrand, France

Centre Georges Francois Leclerc; Oncologie 3; 🇫🇷 Dijon, France

Centre Oscar Lambret; Senologie; 🇫🇷 Lille, France

Hopital Dupuytren; Oncologie Medicale; 🇫🇷 Limoges, France

Hopital Prive Jean Mermoz; Cancerologie; 🇫🇷 Lyon, France

Institut régional du Cancer Montpellier; 🇫🇷 Montpellier, France

Institut Universitaire du Cancer de Toulouse-Oncopole; 🇫🇷 Toulouse, France

Acad. F. Todua Medical Center; 🇬🇪 Tbilisi, Georgia

Israel-Georgian Medical Research Clinic Healthycore; 🇬🇪 Tbilisi, Georgia

Cancer Research Centre; 🇬🇪 Tbilisi, Georgia

Tbilisi Oncology Dispensary; 🇬🇪 Tbilisi, Georgia

Multiprofile Clinic Consilium Medulla; 🇬🇪 Tbilisi, Georgia

S Khechinashvili University Clinic Ltd; 🇬🇪 Tbilisi, Georgia

Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters; 🇩🇪 Berlin, Germany

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum; 🇩🇪 Essen, Germany

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Mannheim; Frauenklinik; 🇩🇪 Mannheim, Germany

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie; 🇩🇪 Trier, Germany

Universitätsfrauenklinik Ulm; Abteilung Gynäkologie; 🇩🇪 Ulm, Germany

Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine; 🇬🇷 Athens, Greece

Univ General Hosp Heraklion; Medical Oncology; 🇬🇷 Heraklion, Greece

Euromedical General Clinic of Thessaloniki; Oncology Department; 🇬🇷 Thessaloniki, Greece

Queen Mary Hospital; Dept of Medicine; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; Department of Clinical Onocology; 🇭🇰 Shatin, Hong Kong

Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly; 🇭🇺 Budapest, Hungary

Uzsoki Utcai Korhaz; Onkoradiológiai Osztály; 🇭🇺 Budapest, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont; 🇭🇺 Szolnok, Hungary

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Napoli, Campania, Italy

A.O. Universitaria Di Parma; 🇮🇹 Parma, Emilia-Romagna, Italy

Irccs Centro Di Riferimento Oncologico (CRO); 🇮🇹 Aviano, Friuli-Venezia Giulia, Italy

Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina; 🇮🇹 Brescia, Lombardia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Lombardia, Italy

Ospedale Santa Maria Annunziata; Oncologia; 🇮🇹 Bagno a Ripoli, Toscana, Italy

Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2; 🇮🇹 Pisa, Toscana, Italy

IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II; 🇮🇹 Padova, Veneto, Italy

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Medical Center; 🇰🇷 Daegu, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang-si, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

National Cancer Institute IKN; 🇲🇾 Putrajaya, Federal Territory OF Putrajaya, Malaysia

Hospital Sultan Ismail; Oncology; 🇲🇾 Johor Bahru, Johor, Malaysia

Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care; 🇲🇾 Sarawak, Malaysia

Palmerston North Hospital; Regional Cancer Treatment Service; 🇳🇿 Palmerston North, New Zealand

Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi; 🇵🇱 Gliwice, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski; 🇵🇱 Konin, Poland

Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym; 🇵🇱 Opole, Poland

Lecznice Citomed Sp. z o.o.; 🇵🇱 Torun, Poland

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr; 🇵🇱 Warszawa, Poland

Centro Clinico Champalimaud; Oncologia Medica; 🇵🇹 Lisboa, Portugal

IPO do Porto; Servico de Oncologia Medica; 🇵🇹 Porto, Portugal

Moscow Clinical Scientific Center; 🇷🇺 Moscow, Moskovskaja Oblast, Russian Federation

Blokhin Cancer Research Center; Out-Patients Dept; 🇷🇺 Moscow, Moskovskaja Oblast, Russian Federation

MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy; 🇷🇺 Moscow, Moskovskaja Oblast, Russian Federation

LLC Medscan; 🇷🇺 Moskva, Moskovskaja Oblast, Russian Federation

Clinical Hospital Lapino (LLC Haven); 🇷🇺 Yudino, Moskovskaja Oblast, Russian Federation

Medical Clinic "AB Medical group"; 🇷🇺 Sankt-peterburg, Sankt Petersburg, Russian Federation

Volgograd Regional Clinical Oncology Dispensary; 🇷🇺 Volgograd, Russian Federation

Regional Clinical Oncology Hospital; 🇷🇺 Yaroslavl, Russian Federation

National University Hospital; National University Cancer Institute, Singapore (NCIS); 🇸🇬 Singapore, Singapore

National Cancer Centre; Medical Oncology; 🇸🇬 Singapore, Singapore

Hospital General Universitario de Elche; Servicio de Oncologia; 🇪🇸 Elche, Alicante, Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario Puerta de Hierro; Servicio de Oncologia; 🇪🇸 Majadahonda, Madrid, Spain

Vall d?Hebron Institute of Oncology (VHIO), Barcelona; 🇪🇸 Barcelona, Spain

Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

Massachusetts General Hospital.; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Sarah Cannon Research Institute / Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Texas Tech University Health Sciences Center; Department of Internal Medicine; 🇺🇸 El Paso, Texas, United States

Texas Oncology - Northeast Texas; 🇺🇸 Tyler, Texas, United States

Northwest Medical Specialties; 🇺🇸 Tacoma, Washington, United States

Fundación CENIT para la Investigación en Neurociencias; 🇦🇷 Buenos Aires, Argentina

Centro Oncologico Korben; Oncology; 🇦🇷 Ciudad Autonoma Buenos Aires, Argentina

Hosp Provincial D. Centenarios; Oncology Dept; 🇦🇷 Rosario, Argentina

Macquarie University Hospital; 🇦🇺 Macquarie Park, New South Wales, Australia

Westmead Hospital; Medical Oncology and Pallative Care; 🇦🇺 Westmead, New South Wales, Australia

Southern Medical Day Care Centre; 🇦🇺 Wollongong, New South Wales, Australia

Mater Adult Hospital; Oncology; 🇦🇺 South Brisbane, Queensland, Australia

Princess Alexandra Hospital; Cancer Trials Unit; 🇦🇺 Woolloongabba, Queensland, Australia

Western Health; 🇦🇺 Fitzroy, Victoria, Australia

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

Peninsula and South Eastern Haematology and Oncology Group; 🇦🇺 Frankston, Victoria, Australia

Hospital Araujo Jorge; Departamento de Ginecologia E Mama; 🇧🇷 Goiania, GO, Brazil

Santa Casa de Misericordia de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Tom Baker Cancer Centre-Calgary; 🇨🇦 Calgary, Alberta, Canada

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda; 🇧🇷 Sao Paulo, SP, Brazil

London Regional Cancer Program, London Health Sciences Centre, Baines Centre; 🇨🇦 London, Ontario, Canada

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada

Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2; 🇺🇦 Ivano-Frankivsk, KIEV Governorate, Ukraine

City Clinical Hospital #4; 🇺🇦 Dnipropetrovsk, Ukraine

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department; 🇺🇦 Kryvyi Rih, Ukraine

Kyiv City Clinical Oncological Center; 🇺🇦 Kyiv, Ukraine

RCI Sumy Regional Clinical Oncological Dispensary; 🇺🇦 Sumy, Ukraine

Princess Alexandra Hospital; Oncology Department; 🇬🇧 Harlow, United Kingdom

Barts Health NHS Trust; Cancer Research Delivery Group; 🇬🇧 London, United Kingdom

St Georges University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Churchill Hospital; Department of Oncology; 🇬🇧 Oxford, United Kingdom

Peterborough City Hospital, Edith Cavell Campus; Oncology Department; 🇬🇧 Peterborough, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom