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

December 11, 2024 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
        • Icon Cancer Care - The Wesley Medical Centre
      • Freches Forest, Australia, 2086
        • Northern Beaches Hospital
      • Victor Harbor, Australia, 5211
        • South Coast District Hospital
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • North Tamworth, New South Wales, Australia, 2340
        • North West Cancer Centre
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • Sydney, New South Wales, Australia, 2060
        • Mater Hospital Sydney
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Elizabeth Vale, South Australia, Australia, 5112
        • Adelaide Oncology and Haematology, Calvary Central Districts Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Royal Hobart Hospital
      • Hobart, Tasmania, Australia, 7000
        • Icon Cancer Centre - Hobart
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital Outpatients
      • Box Hill, Victoria, Australia, 3128
        • Epworth Eastern Hospital
      • Brighton, Victoria, Australia, 3186
        • Melbourne Cancer Care
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
      • Richmond, Victoria, Australia, 3121
        • Dr. Zimet Private Room
      • Richmond, Victoria, Australia, 3121
        • Slade Pharmacy Epworth Hospital
      • Shepparton, Victoria, Australia, 3630
        • Goulburn Valley Health
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Tom Baker Cancer Center
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program
      • Toronto, Ontario, Canada, M5B 1W8
        • Unity Health Toronto, St. Michael's Hospital
    • Quebec
      • Québec, Quebec, Canada, G1V 4G2
        • CHUL du CHU de Québec
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Egypt
    • Cairo Governorate
      • Mohandeseen, Cairo Governorate, Egypt, 12655
        • Cairo Oncology Center (Cairo Cure)
  • India
      • New Delhi, India, 110076
        • Indraprastha Apollo Hospital
    • Chennai
      • Teynampet, Chennai, India, 600018
        • Apollo Cancer Institute, Apollo Speciality Hospital
  • Italy
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
    • Roma
      • Torre, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Istituto Oncologico Veneto IRCCS
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia, 59100
        • Universiti Malaya Medical Centre
      • Putrajaya, Malaysia, 62250
        • Institut Kanser Negara
    • Kedah
      • Sungai Petani, Kedah, Malaysia, 08000
        • Pantai Hospital Sungai Petani
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • Pantai Hospital Kuala Lumpur
    • Petaling JAYA
      • Off Jalan Templer, Petaling JAYA, Malaysia, 46050
        • Beacon Hospital
    • Pulau Pinang
      • Bayan BARU, Pulau Pinang, Malaysia, 11900
        • Pantai Hospital Penang
      • George Town, Pulau Pinang, Malaysia, 10050
        • Gleneagles Penang
      • George Town, Pulau Pinang, Malaysia, 10400
        • Loh Guan Lye Specialists' Centre
      • George Town, Pulau Pinang, Malaysia, 11350
        • Penang Adventist Hospital
      • Tanjung Bungah, Pulau Pinang, Malaysia, 11200
        • Mount Miriam Cancer Hospital
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Hospital Umum Sarawak
    • Selangor
      • Petaling Jaya, Selangor, Malaysia, 47500
        • Subang Jaya Medical Centre
  • Singapore
      • Singapore, Singapore, 228510
        • Elizabeth Au Oncology
  • South Africa
      • Cape Town, South Africa, 7700
        • Cancercare Rondebosch Oncology
      • eManzimtoti, South Africa, 4126
        • Dr Pirjol and Szpak Inc. Oncology Pratice
    • Cape Town
      • Pinelands, Cape Town, South Africa, 7405
        • Vincent Pallotti Hospital
    • Gauteng
      • Floracliff, Gauteng, South Africa, 1715
        • Flora Clinic
      • Johannesburg, Gauteng, South Africa, 2196
        • The Medical Oncology Centre of Rosebank
      • Johannesburg, Gauteng, South Africa, 2158
        • Olivedale Clinic
      • Johannesburg, Gauteng, South Africa, 2192
        • Netcare Linksfield Hospital
      • Johannesburg, Gauteng, South Africa, 2193
        • Donald Gordon Medical Center
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Donald Gordon Clinical Trial Center
      • Morningside, Gauteng, South Africa, 2196
        • Sandton Oncology
      • Parktown, Gauteng, South Africa, 2193
        • DGMC Oncology
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4126
        • Amanzimtoti Oncology Centre
      • Hilton, KwaZulu-Natal, South Africa, 3245
        • Hopelands Cancer Centre Hilton
      • Richards Bay, KwaZulu-Natal, South Africa, 3900
        • Abraham Oncology
    • Western Cape
      • George, Western Cape, South Africa, 7764
        • Cancercare
  • South Korea
      • Chungcheongbuk-do, South Korea, 28644
        • Chungbuk National University Hospital
      • Daegu, South Korea, 41404
        • Kyungpook National University Medical Center Chilgok Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
    • Goyang-si Gyeonggi-do
      • Ilsandong-gu, Goyang-si Gyeonggi-do, South Korea, 10408
        • National Cancer Center
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], South Korea, 22332
        • Inha University Hospital
    • Korea
      • Gyeonggi-do, Korea, South Korea, 11765
        • St. Mary's Hospital
      • Namdong-gu, Incheon, Korea, South Korea, 21556
        • Gachon University Gil Medical Center
      • Seoul, Korea, South Korea, 06591
        • Seoul St. Mary'S Hospital
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, South Korea, 10408
        • National Cancer Center
    • Seoul, Korea
      • Seoul, Seoul, Korea, South Korea, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Samsung Medical Center
    • Yangcheon-gu
      • Seoul, Yangcheon-gu, South Korea, 07985
        • Ewha University Mokdong Hospital
  • Spain
      • A Coruña, Spain, 15405
        • Hospital Arquitecto Marcide (Área Sanitaria de Ferrol)
      • Albacete, Spain, 02006
        • Hospital General de Albacete
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08023
        • Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
      • Barcelona, Spain, 08023
        • Hospital Quironsalud Barcelona- END
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeusa
      • Barcelona, Spain, 08028
        • Instituto Oncologico Dr Rosell (IOR)
      • Granada, Spain, 18016
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Madrid, Spain, 28033
        • Centro Oncologico MD Anderson
      • Madrid, Spain, 28981
        • Hospital Infanta Cristina
      • Madrid, Spain, 28022
        • Cl. Universitaria Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario Valencia
      • Valencia, Spain, 46500
        • Hospital de Sagunto
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
      • Zaragoza, Spain, 50006
        • IDCQ HOSPITALES Y SANIDAD, S.L.U. (Hospital Quirón Zaragoza)
      • Zaragoza, Spain, 50009
        • Hospital Universitario Zaragoza
    • Alicante
      • Alcoy, Alicante, Spain, 03800
        • Hospital Virgen de los Lirios
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Barcelona
      • Girona, Barcelona, Spain, 17007
        • Hospital Universitari de Girona Dr. Josep Trueta
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Duran i Reynals
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Catala D'oncologia
      • Sabadell, Barcelona, Spain, 08208
        • Corporación Sanitaria Parc Taulí
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Sant Cugat del Vallès, Barcelona [Barcelona], Spain, 08915
        • Hospital Universitari General de Catalunya
    • Catalunya [Cataluña]
      • Badalona, Catalunya [Cataluña], Spain, 08916
        • Hospital Germans Trías i Pujol
    • La Laguna
      • Santa Cruz de Tenerife, La Laguna, Spain, 38320
        • Hospital Universitario de Canarias
    • Madrid
      • Aravaca, Madrid, Spain, 28023
        • Hospital La Zarzuela
      • Móstoles, Madrid, Spain, 28935
        • Hospital De Mostoles
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramon y Cajal
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
    • Palma de Mallorca(Baleares)
      • Palma de Mallorca, Palma de Mallorca(Baleares), Spain, 07120
        • Hospital Universitario Son Espases
    • Valencia
      • Gandia, Valencia, Spain, 46702
        • H. San Francisco de Borja (H. GANDIA)
      • Xàtiva, Valencia, Spain, 46800
        • Hospital Lluis Alcanyis
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • Switzerland
      • Geneva, Switzerland, 1205
        • Hopitaux Universitaires de Geneve
      • Geneva, Switzerland, 1211
        • HUG-Hôpitaux Universitaires de Genève
      • Lucerne, Switzerland, 6000
        • Luzerner Kantonsspital
      • Zurich, Switzerland, 8038
        • OnkoZentrum Zürich AG
    • Canton Ticino
      • Lugano, Canton Ticino, Switzerland, 6900
        • Oncologia Varini Calderoni Christinat
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Universitätsspital Basel
    • Canton of Geneva
      • Meyrin, Canton of Geneva, Switzerland, 1217
        • Hôpital de la Tour, La Tour Hôpital Privé SA
    • Canton of St. Gallen
      • Rapperswil, Canton of St. Gallen, Switzerland, 8640
        • Tumorzentrum ZeTuP Rapperswil-Jona
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9000
        • Tumor- und Brustzentrum ZeTuP Sankt Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan, 812
        • Kaohsiung Municipal Siaogang Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 100229
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yan-Sen Cancer Center
    • Chiayi County
      • Putzu City, Chiayi County, Taiwan, 61363
        • Chiayi Chang Gung Memorial Hospital
    • Kaohsiung City
      • Niaosong Dist, Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Zhongzheng District, Taipei, Taiwan, 10048
        • National Taiwan University Hospital Yunlin Branch
    • Tamsui District
      • New Taipei City, Tamsui District, Taiwan, 251
        • Mackay Memorial Hospital
    • Tanzi District
      • Taichung, Tanzi District, Taiwan, 427
        • Taichung Tzu Chi Hospital
    • Taoyuan District
      • Taoyuan, Taoyuan District, Taiwan, 330
        • Saint Paul's Hospital
    • Yunlin County, Douliu City
      • Yunlin County, Douliu City, Yunlin County, Douliu City, Taiwan, 64041
        • National Taiwan University Hospital Yunlin Branch
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memoiral Hospsital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hopsital
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Songklanagarind Hospital
    • Chiangmai
      • Muang Chiangmai, Chiangmai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
    • Ratchathewi District
      • Bangkok, Ratchathewi District, Thailand, 10400
        • Rajavithi Hospital
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
    • Hertfordshire
      • Radlett, Hertfordshire, United Kingdom, WD7 8AA
        • Loom Dene
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Northern Centre for Cancer Treatment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 16, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17088
  • I3Y-MC-Y001 (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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