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New drug shows promise for Hard-to-Treat breast cancer

NCT ID NCT03523585

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, trastuzumab deruxtecan (DS-8201a), against standard treatments for people with advanced HER2-positive breast cancer that had already been treated with T-DM1. The trial included 608 participants whose cancer could not be removed by surgery or had spread to other parts of the body. The main goal was to see if the new drug could delay cancer growth or improve survival compared to standard options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

608 people

The number who actually took part.

Started

Aug 2018

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is the age of majority in their country * Has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory 3. was previously treated with ado-trastuzumab emtansine (T-DM1) * Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy) * Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy. * Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least: 1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) 2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants) 3. 7 months after the last dose of trastuzumab/capecitabine * Has adequate hematopoietic, renal and hepatic functions Exclusion Criteria: * Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy * Has had prior treatment with capecitabine * Has uncontrolled or significant cardiovascular disease * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening * Has active central nervous system (CNS) metastases

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 251 General Air Force Hospital

    Athens, 11525, Greece

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900, Brazil

  • A.O.U. Policlinico di Modena

    Modena, 41124, Italy

  • AMO - Assistência Multidisciplinar em Oncologia

    Salvador, Estado de Bahia, 41950-640, Brazil

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Aberdeen Royal Infirmary

    Aberdeen, Grampian Region, AB25 2ZB, United Kingdom

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • Acibadem Adana Hospital

    Adana, 01130, Turkey (Türkiye)

  • Adana Numune Training and Research Hospital

    Adana, 01370, Turkey (Türkiye)

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681, Japan

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Akdeniz University Medical Faculty

    Antalya, 07058, Turkey (Türkiye)

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital

    Ankara, 6800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037, Australia

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Azienda Ospealiera della Provincia di Lecco

    Lecco, 23900, Italy

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

    Messina, 98158, Italy

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Cona, 44124, Italy

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127, Italy

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, Milano, 20900, Italy

  • Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

    Istanbul, 34147, Turkey (Türkiye)

  • Ballarat Oncology & Haematology Service

    Wendouree, Victoria, 3355, Australia

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin, Cotes d'Armor, 22190, France

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André, São Paulo, 09060-650, Brazil

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030, France

  • CHU Brest - Hôpital Morvan

    Brest, Finistere, 29609, France

  • CHU UCL Namur site de Sainte Elisabeth

    Namur, 5000, Belgium

  • COI - Clínicas Oncológicas Integradas

    Rio de Janeiro, 22793-080, Brazil

  • CRLCC Eugene Marquis

    Rennes, Ille Et Vilaine, 35042, France

  • Calvary North Adelaide Hospital

    Bruce, 2614, Australia

  • Centre François Baclesse

    Caen, Calvados, 14076, France

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079, France

  • Centre Henri Becquerel

    Rouen, Seine Maritime, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495, France

  • Centre Hospitalier de la côte Basque

    Bayonne, Pyrenees Atlantiques, 64109, France

  • Centre Oscar Lambret

    Lille, Nord, 59020, France

  • Centre René Huguenin

    Saint-Cloud, Hauts De Seine, 92110, France

  • Centre de cancerologie les Dentellieres

    Valenciennes, Nord, 59300, France

  • Chaim Sheba Medical Center

    Ramat Gan, 52363, Israel

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

  • CliniOnco - Tratamento Integrado do Câncer

    Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

  • Clinique Clementville

    Montpellier, Herault, 34070, France

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, Sarthe, 72015, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Community Hospital

    Munster, Indiana, 46321, United States

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006, Spain

  • Cornell-Beshore Cancer Institute

    Joplin, Missouri, 64804, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dayton Physicians, LLC

    Kettering, Ohio, 45409, United States

  • Derriford Hospital

    Plymouth, Devon, PL6 8BQ, United Kingdom

  • Escosteguy Barrios, Carlos Henrique

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Euromedica General Clinic Thessaloniki

    Thessaloniki, 54645, Greece

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Florida Cancer Specialists-Broadway

    Fort Myers, Florida, 33901, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Frankston Hospital

    Frankston, Victoria, 3199, Australia

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • General Hospital of Athens "Alexandra"

    Athens, 11528, Greece

  • General Oncology Hospital of Kifissia " Agioi Anargyroi"

    Athens, 14564, Greece

  • HGB - Hospital Giovanni Battista - Mãe de Deus Center

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001, Israel

  • Haematologisch-Onkologische Schwerpunktpraxis

    Troisdorf, 53840, Germany

  • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

    Kansas City, Missouri, 64132, United States

  • Helios-Kliniken Berlin-Buch

    Berlin, 13125, Germany

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518, Japan

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Infanta Cristina

    Badajoz, 06007, Spain

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37370, Spain

  • Hospital de Especialidades de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Hyōgo College of Medicine Hospital

    Hyōgo, 663-8501, Japan

  • Hôpital Nord - CHU Marseille

    Marseille, Bouches-du-Rhône, 13915, France

  • Hôpital Privé d'Antony

    Antony, Hauts De Seine, 92160, France

  • IBCC - Instituto Brasileiro de Controle do Câncer

    São Paulo, São Paulo, 03102-002, Brazil

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IEO Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128, Italy

  • IRCCS Centro di Riferimento Oncologico

    Aviano, Pordenone, 33081, Italy

  • Inha University Hospital

    Incheon, Gyeonggi-do, 22332, South Korea

  • Innovative Clinical Research Institute

    Whittier, California, 90603, United States

  • Institut Curie - site de Paris

    Paris, Paris, 75005, France

  • Institut Curie - site de Paris

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805, France

  • Institut Régional du Cancer de Montpellier

    Montpellier, Herault, 34298, France

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298, France

  • Institut Sainte Catherine

    Avignon, Vaculuse, 84918, France

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009, Spain

  • Ironwood Cancer Research Centers

    Chandler, Arizona, 85224, United States

  • Istanbul Medeniyet Uni Goztepe Training & Research Hospital

    Istanbul, 34854, Turkey (Türkiye)

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova, 16132, Italy

  • Izmir Medicalpark Hospital

    Izmir, 35530, Turkey (Türkiye)

  • Kanagawa Cancer Center

    Kanagawa, 241-8515, Japan

  • Kapiolani Medical Center for Women and Children/Univ of HI

    Honolulu, Hawaii, 96826, United States

  • Kartal Lutfi Kirdar Research and Training Hospital

    Istanbul, 34890, Turkey (Türkiye)

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kindai University Hospital

    Ōsakasayama-shi, Osaka, 589-8511, Japan

  • Kliniken Koeln

    Cologne, 51067, Germany

  • Klinikum der Universitaet Muenchen - Campus Grosshardern

    Munich, 81377, Germany

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675, Germany

  • Konya Necmettin Erbakan University Meram Faculty of Medicine

    Konya, 42080, Turkey (Türkiye)

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Loyola University Health System

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Centre

    Madrid, 28033, Spain

  • Macquarie University Hospital

    Sydney, New South Wales, 2109, Australia

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074, United States

  • Marienhospital Bottrop gGmbH

    Bottrop, Rhineland-Palatinate, 46236, Germany

  • Medical Park Goztepe Hospital

    Istanbul, 34732, Turkey (Türkiye)

  • Medical Park Samsun Hastanesi

    Samsun, 55200, Turkey (Türkiye)

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

    New York, New York, 10065, United States

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405, United States

  • NHO Hokkaido Cancer Center

    Hokkaido, 003-0804, Japan

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • NHO Osaka National Hospital

    Osaka, 540-0006, Japan

  • NHO Shikoku Cancer Center

    Ehime, 791-0280, Japan

  • NOB - Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110, Brazil

  • Namik Kemal University

    Tekirdağ, 59100, Turkey (Türkiye)

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital

    Chūōku, Tokyo-To, 104-0045, Japan

  • Nemocnice Na Bulovce

    Prague, 180 81, Czechia

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Nottingham University Hospitals City Campus

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Oncobio Servicos de Saude

    Nova Lima, Minas Gerais, 34000, Brazil

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ospedale Sacro Cuore Don Calabria

    Negrar, Verona, 37024, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Pacific Cancer Care

    Monterey, California, 93940, United States

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Pronutrir

    Fortaleza, Ceará, 60810-180, Brazil

  • Queen Mary University of London

    London, Greater London, EC1M 6BQ, United Kingdom

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 49100, Israel

  • Rambam Health Care Center

    Haifa, 3109601, Israel

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, EX2 5DW, United Kingdom

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Sakarya Traning and Research Hospital

    Sakarya, 54187, Turkey (Türkiye)

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sapir Medical Center, Meir Hospital

    Kfar Saba, 4428164, Israel

  • Sarah Cannon Research Institute UK

    London, Greater London, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University

    Seoul, 03772, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sharp Memorial Hospital

    San Diego, California, 92123, United States

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510, United States

  • Sociedade Beneficiente de Senhoras Hospital Sírio Libanês

    São Paulo, 01308, Brazil

  • South West Oncology

    Warrnambool, Victoria, 3280, Australia

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008, Australia

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 216-8511, Japan

  • Sunshine Hospital

    Saint Albans, Victoria, 3021, Australia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Tennessee Oncology, PLLC Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030, United States

  • The Ohio State University

    Columbus, Ohio, 43235, United States

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485, Australia

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • The West Clinic

    Germantown, Tennessee, 38138, United States

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • UCLA Hematology Oncology - Main Site

    Los Angeles, California, 90095, United States

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15213, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uludag University Medical Faculty

    Bursa, 16059, Turkey (Türkiye)

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103, Germany

  • Universitaetsklinikum Muenster

    Müenster, 48149, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • University College London Hospitals

    London, Greater London, NW1 2PG, United Kingdom

  • University General Hospital of Heraklion

    Heraklion, 71110, Greece

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Western General Hospital

    Edinburgh, Lothian Region, EH4 2XU, United Kingdom

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