Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

NCT ID: NCT03763604

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Interventions

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Abemaciclib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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Inclusion Criteria

* Patients with hormone receptor positive metastatic breast cancer for whom there is reasonable expectation that abemaciclib may provide clinical benefit and who are suitable to receive abemaciclib.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status

North West Cancer Centre

North Tamworth, New South Wales, Australia

Site Status

St Vincent's Hospital Sydney

Sydney, New South Wales, Australia

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Mater Hospital Sydney

Sydney, New South Wales, Australia

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Westmead Hospital

Westmead, New South Wales, Australia

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Wollongong Hospital

Wollongong, New South Wales, Australia

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

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Adelaide Oncology and Haematology, Calvary Central Districts Hospital

Elizabeth Vale, South Australia, Australia

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Icon Cancer Centre - Hobart

Hobart, Tasmania, Australia

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Royal Hobart Hospital

Hobart, Tasmania, Australia

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Box Hill Hospital Outpatients

Box Hill, Victoria, Australia

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Epworth Eastern Hospital

Box Hill, Victoria, Australia

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Melbourne Cancer Care

Brighton, Victoria, Australia

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Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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Dr. Zimet Private Room

Richmond, Victoria, Australia

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Slade Pharmacy Epworth Hospital

Richmond, Victoria, Australia

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Goulburn Valley Health

Shepparton, Victoria, Australia

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Icon Cancer Care - The Wesley Medical Centre

Auchenflower, , Australia

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Northern Beaches Hospital

Freches Forest, , Australia

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South Coast District Hospital

Victor Harbor, , Australia

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Tom Baker Cancer Center

Calgary, Alberta, Canada

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Cross Cancer Institute

Edmonton, Alberta, Canada

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BC Cancer Vancouver

Vancouver, British Columbia, Canada

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British Columbia Cancer Agency - Vancouver Island

Victoria, British Columbia, Canada

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Grand River Regional Cancer Centre

Kitchener, Ontario, Canada

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The Ottawa Hospital

Ottawa, Ontario, Canada

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Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

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Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

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CHUL du CHU de Québec

Québec, Quebec, Canada

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Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

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Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

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Cairo Oncology Center (Cairo Cure)

Mohandeseen, Cairo Governorate, Egypt

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Apollo Cancer Institute, Apollo Speciality Hospital

Teynampet, Chennai, India

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Indraprastha Apollo Hospital

New Delhi, , India

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Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Torre, Roma, Italy

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Istituto Oncologico Veneto IRCCS

Padua, Veneto, Italy

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Ospedale Di Circolo E Fondazione Macchi

Varese, , Italy

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Pantai Hospital Sungai Petani

Sungai Petani, Kedah, Malaysia

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Pantai Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

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Beacon Hospital

Off Jalan Templer, Petaling JAYA, Malaysia

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Pantai Hospital Penang

Bayan BARU, Pulau Pinang, Malaysia

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Gleneagles Penang

George Town, Pulau Pinang, Malaysia

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Loh Guan Lye Specialists' Centre

George Town, Pulau Pinang, Malaysia

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Penang Adventist Hospital

George Town, Pulau Pinang, Malaysia

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Mount Miriam Cancer Hospital

Tanjung Bungah, Pulau Pinang, Malaysia

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Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

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Subang Jaya Medical Centre

Petaling Jaya, Selangor, Malaysia

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Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

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Universiti Malaya Medical Centre

Kuala Lumpur, , Malaysia

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University Malaya Medical Centre

Kuala Lumpur, , Malaysia

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Institut Kanser Negara

Putrajaya, , Malaysia

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Elizabeth Au Oncology

Singapore, , Singapore

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Vincent Pallotti Hospital

Pinelands, Cape Town, South Africa

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Flora Clinic

Floracliff, Gauteng, South Africa

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Olivedale Clinic

Johannesburg, Gauteng, South Africa

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Netcare Linksfield Hospital

Johannesburg, Gauteng, South Africa

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Donald Gordon Medical Center

Johannesburg, Gauteng, South Africa

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Wits Donald Gordon Clinical Trial Center

Johannesburg, Gauteng, South Africa

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The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

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Sandton Oncology

Morningside, Gauteng, South Africa

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DGMC Oncology

Parktown, Gauteng, South Africa

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Amanzimtoti Oncology Centre

Durban, KwaZulu-Natal, South Africa

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Hopelands Cancer Centre Hilton

Hilton, KwaZulu-Natal, South Africa

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Abraham Oncology

Richards Bay, KwaZulu-Natal, South Africa

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Cancercare

George, Western Cape, South Africa

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Cancercare Rondebosch Oncology

Cape Town, , South Africa

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Dr Pirjol and Szpak Inc. Oncology Pratice

eManzimtoti, , South Africa

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National Cancer Center

Ilsandong-gu, Goyang-si Gyeonggi-do, South Korea

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

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Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

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St. Mary's Hospital

Gyeonggi-do, Korea, South Korea

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Gachon University Gil Medical Center

Namdong-gu, Incheon, Korea, South Korea

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Seoul St. Mary's Hospital

Seoul, Korea, South Korea

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National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

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Seoul National University Hospital

Seoul, Seoul, Korea, South Korea

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Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

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Ewha University Mokdong Hospital

Seoul, Yangcheon-gu, South Korea

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Chungbuk National University Hospital

Chungcheongbuk-do, , South Korea

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Kyungpook National University Medical Center Chilgok Hospital

Daegu, , South Korea

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Korea University Anam Hospital

Seoul, , South Korea

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

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Gangnam Severance Hospital

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

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Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

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Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

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Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona [Barcelona], Spain

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Hospital Universitari de Girona Dr. Josep Trueta

Girona, Barcelona, Spain

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Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

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Hospital Duran I Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

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Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

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Hospital Germans Trias i Pujol

Badalona, Catalunya [Cataluña], Spain

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Hospital Universitario de Canarias

Santa Cruz de Tenerife, La Laguna, Spain

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Hospital la Zarzuela

Aravaca, Madrid, Spain

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Hospital De Mostoles

Móstoles, Madrid, Spain

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Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

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Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

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Hospital Universitario Son Espases

Palma de Mallorca, Palma de Mallorca(Baleares), Spain

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H. San Francisco de Borja (H. GANDIA)

Gandia, Valencia, Spain

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Hospital Lluis Alcanyis

Xàtiva, Valencia, Spain

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Hospital De Basurto

Bilbao, Vizcaya, Spain

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Hospital Arquitecto Marcide (Área Sanitaria de Ferrol)

A Coruña, , Spain

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Hospital General de Albacete

Albacete, , Spain

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Hospital Quironsalud Barcelona- END

Barcelona, , Spain

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Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga

Barcelona, , Spain

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Hospital Universitari Dexeusa

Barcelona, , Spain

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Instituto Oncologico Dr Rosell (IOR)

Barcelona, , Spain

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Hospital Universitari Vall d'Hebron

Barcelona, , Spain

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Hospital Universitario San Cecilio

Granada, , Spain

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Cl. Universitaria Navarra

Madrid, , Spain

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Centro Oncológico MD Anderson

Madrid, , Spain

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Hospital Ruber Internacional

Madrid, , Spain

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Hospital Universitario 12 de Octubre

Madrid, , Spain

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Hospital Madrid Norte Sanchinarro

Madrid, , Spain

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Hospital Infanta Cristina

Madrid, , Spain

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Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

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Fundación Instituto Valenciano de Oncología

Valencia, , Spain

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Hospital Clinico Universitario Valencia

Valencia, , Spain

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Hospital Clínico Universitario de Valencia

Valencia, , Spain

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Hospital Arnau de Vilanova Valencia

Valencia, , Spain

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Hospital Doctor Peset

Valencia, , Spain

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Hospital de Sagunto

Valencia, , Spain

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IDCQ HOSPITALES Y SANIDAD, S.L.U. (Hospital Quirón Zaragoza)

Zaragoza, , Spain

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Hospital Universitario Miguel Servet

Zaragoza, , Spain

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Hospital Universitario Zaragoza

Zaragoza, , Spain

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Universitätsspital Basel

Basel, Canton of Basel-City, Switzerland

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Hôpital de la Tour, La Tour Hôpital Privé SA

Meyrin, Canton of Geneva, Switzerland

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Tumorzentrum ZeTuP Rapperswil-Jona

Rapperswil, Canton of St. Gallen, Switzerland

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Tumor- und Brustzentrum ZeTuP Sankt Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

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Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

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Oncologia Varini Calderoni Christinat

Lugano, Canton Ticino, Switzerland

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Hôpitaux Universitaires de Genève

Geneva, , Switzerland

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HUG-Hôpitaux Universitaires de Genève

Geneva, , Switzerland

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Luzerner Kantonsspital

Lucerne, , Switzerland

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OnkoZentrum Zürich AG

Zurich, , Switzerland

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Chiayi Chang Gung Memorial Hospital

Putzu City, Chiayi County, Taiwan

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Kaohsiung Chang Gung Memorial Hospital

Niaosong Dist, Kaohsiung City, Taiwan

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Tri-Service General Hospital

Taipei City, Taipei, Taiwan

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National Taiwan University Hospital Yunlin Branch

Zhongzheng District, Taipei, Taiwan

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MacKay Memorial Hospital

New Taipei City, Tamsui District, Taiwan

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Taichung Tzu Chi Hospital

Taichung, Tanzi District, Taiwan

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Saint Paul's Hospital

Taoyuan District, Taoyuan District, Taiwan

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National Taiwan University Hospital Yunlin Branch

Yunlin County, Douliu City, Yunlin County, Douliu City, Taiwan

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

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Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, , Taiwan

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China Medical University Hospital

Taichung, , Taiwan

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Taichung Veterans General Hospital

Taichung, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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Mackay Memorial Hospital

Taipei, , Taiwan

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Taipei Veterans General Hospital

Taipei, , Taiwan

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Koo Foundation Sun Yan-Sen Cancer Center

Taipei, , Taiwan

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Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

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Maharaj Nakorn Chiang Mai Hospital

Muang Chiangmai, Chiangmai, Thailand

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Rajavithi Hospital

Bangkok, Ratchathewi District, Thailand

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King Chulalongkorn Memoiral Hospsital

Bangkok, , Thailand

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Ramathibodi Hopsital

Bangkok, , Thailand

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Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

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Loom Dene

Radlett, Hertfordshire, United Kingdom

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Northern Centre for Cancer Treatment

Newcastle upon Tyne, Tyne and Wear, United Kingdom

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Countries

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Australia Canada Egypt India Italy Malaysia Singapore South Africa South Korea Spain Switzerland Taiwan Thailand United Kingdom

Other Identifiers

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I3Y-MC-Y001

Identifier Type: OTHER

Identifier Source: secondary_id

17088

Identifier Type: -

Identifier Source: org_study_id