Metastatic Breast CancerNCT03763604
Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
A study testing Abemaciclib in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 160 sites in 14 countries.
Trial summary
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 160 sitesin 14 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
160 sites in 14 countries.
160 sites in 14 countries
Spain42 sites
Hospital Arquitecto Marcide (Área Sanitaria de Ferrol)
A Coruña, 15405
Hospital General de Albacete
Albacete, 02006
Hospital Virgen de los Lirios
Alcoy, Alicante, 03800
Hospital la Zarzuela
Aravaca, Madrid, 28023
Hospital Germans Trias i Pujol
Badalona, Catalunya [Cataluña], 08916
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 8035
Hospital Quironsalud Barcelona- END
Barcelona, 08023
Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
Barcelona, 08023
Hospital Universitari Dexeusa
Barcelona, 08028
Instituto Oncologico Dr Rosell (IOR)
Barcelona, 08028
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital De Basurto
Bilbao, Vizcaya, 48013
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
H. San Francisco de Borja (H. GANDIA)
Gandia, Valencia, 46702
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Barcelona, 17007
Hospital Universitario San Cecilio
Granada, 18016
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Cl. Universitaria Navarra
Madrid, 28022
Centro Oncológico MD Anderson
Madrid, 28033
Hospital Ruber Internacional
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Madrid Norte Sanchinarro
Madrid, 28050
Hospital Infanta Cristina
Madrid, 28981
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital De Mostoles
Móstoles, Madrid, 28935
Hospital Universitario Son Espases
Palma de Mallorca, Palma de Mallorca(Baleares), 07120
Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona [Barcelona], 08915
Hospital Universitario de Canarias
Santa Cruz de Tenerife, La Laguna, 38320
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Hospital Clinico Universitario Valencia
Valencia, 46010
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Arnau de Vilanova Valencia
Valencia, 46015
Hospital Doctor Peset
Valencia, 46017
Hospital de Sagunto
Valencia, 46500
Hospital Lluis Alcanyis
Xàtiva, Valencia, 46800
IDCQ HOSPITALES Y SANIDAD, S.L.U. (Hospital Quirón Zaragoza)
Zaragoza, 50006
Hospital Universitario Miguel Servet
Zaragoza, 50009
Hospital Universitario Zaragoza
Zaragoza, 50009
Australia20 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Icon Cancer Care - The Wesley Medical Centre
Auchenflower, 4066
Box Hill Hospital Outpatients
Box Hill, Victoria, 3128
Epworth Eastern Hospital
Box Hill, Victoria, 3128
Melbourne Cancer Care
Brighton, Victoria, 3186
Adelaide Oncology and Haematology, Calvary Central Districts Hospital
Elizabeth Vale, South Australia, 5112
Northern Beaches Hospital
Freches Forest, 2086
Icon Cancer Centre - Hobart
Hobart, Tasmania, 7000
Royal Hobart Hospital
Hobart, Tasmania, 7001
Liverpool Hospital
Liverpool, New South Wales, 2170
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
North West Cancer Centre
North Tamworth, New South Wales, 2340
Dr. Zimet Private Room
Richmond, Victoria, 3121
Slade Pharmacy Epworth Hospital
Richmond, Victoria, 3121
Goulburn Valley Health
Shepparton, Victoria, 3630
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
Mater Hospital Sydney
Sydney, New South Wales, 2060
South Coast District Hospital
Victor Harbor, 5211
Westmead Hospital
Westmead, New South Wales, 2145
Wollongong Hospital
Wollongong, New South Wales, 2500
South Korea17 sites
Chungbuk National University Hospital
Chungcheongbuk-do, 28644
Kyungpook National University Medical Center Chilgok Hospital
Daegu, 41404
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
St. Mary's Hospital
Gyeonggi-do, Korea, 11765
National Cancer Center
Ilsandong-gu, Goyang-si Gyeonggi-do, 10408
Inha University Hospital
Incheon, Incheon-gwangyeoksi [Incheon], 22332
Gachon University Gil Medical Center
Namdong-gu, Incheon, Korea, 21556
Seoul St. Mary's Hospital
Seoul, Korea, 06591
Seoul National University Hospital
Seoul, Seoul, Korea, 03080
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Ewha University Mokdong Hospital
Seoul, Yangcheon-gu, 07985
Korea University Anam Hospital
Seoul, 02841
Severance Hospital, Yonsei University Health System
Seoul, 03722
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Taiwan16 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Municipal Siaogang Hospital
Kaohsiung City, 812
MacKay Memorial Hospital
New Taipei City, Tamsui District, 251
Kaohsiung Chang Gung Memorial Hospital
Niaosong Dist, Kaohsiung City, 833
Chiayi Chang Gung Memorial Hospital
Putzu City, Chiayi County, 61363
Taichung Tzu Chi Hospital
Taichung, Tanzi District, 427
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100229
Mackay Memorial Hospital
Taipei, 10449
Taipei Veterans General Hospital
Taipei, 11217
Koo Foundation Sun Yan-Sen Cancer Center
Taipei, 112
Tri-Service General Hospital
Taipei City, Taipei, 114
Saint Paul's Hospital
Taoyuan, Taoyuan District, 330
National Taiwan University Hospital Yunlin Branch
Yunlin County, Douliu City, Yunlin County, Douliu City, 64041
National Taiwan University Hospital Yunlin Branch
Zhongzheng District, Taipei, 10048
South Africa15 sites
Cancercare Rondebosch Oncology
Cape Town, 7700
Amanzimtoti Oncology Centre
Durban, KwaZulu-Natal, 4126
Dr Pirjol and Szpak Inc. Oncology Pratice
eManzimtoti, 4126
Flora Clinic
Floracliff, Gauteng, 1715
Cancercare
George, Western Cape, 7764
Hopelands Cancer Centre Hilton
Hilton, KwaZulu-Natal, 3245
Olivedale Clinic
Johannesburg, Gauteng, 2158
Netcare Linksfield Hospital
Johannesburg, Gauteng, 2192
Donald Gordon Medical Center
Johannesburg, Gauteng, 2193
Wits Donald Gordon Clinical Trial Center
Johannesburg, Gauteng, 2193
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196
Sandton Oncology
Morningside, Gauteng, 2196
DGMC Oncology
Parktown, Gauteng, 2193
Vincent Pallotti Hospital
Pinelands, Cape Town, 7405
Abraham Oncology
Richards Bay, KwaZulu-Natal, 3900
Malaysia14 sites
Pantai Hospital Penang
Bayan BARU, Pulau Pinang, 11900
Gleneagles Penang
George Town, Pulau Pinang, 10050
Loh Guan Lye Specialists' Centre
George Town, Pulau Pinang, 10400
Penang Adventist Hospital
George Town, Pulau Pinang, 11350
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 59100
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Universiti Malaya Medical Centre
Kuala Lumpur, 59100
University Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Umum Sarawak
Kuching, Sarawak, 93586
Beacon Hospital
Off Jalan Templer, Petaling JAYA, 46050
Subang Jaya Medical Centre
Petaling Jaya, Selangor, 47500
Institut Kanser Negara
Putrajaya, 62250
Pantai Hospital Sungai Petani
Sungai Petani, Kedah, 08000
Mount Miriam Cancer Hospital
Tanjung Bungah, Pulau Pinang, 11200
Canada11 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
CHUL du CHU de Québec
Québec, Quebec, G1V 4G2
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
British Columbia Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R 6V5
Switzerland10 sites
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
Hôpitaux Universitaires de Genève
Geneva, 1205
HUG-Hôpitaux Universitaires de Genève
Geneva, 1211
Luzerner Kantonsspital
Lucerne, 6000
Oncologia Varini Calderoni Christinat
Lugano, Canton Ticino, 6900
Hôpital de la Tour, La Tour Hôpital Privé SA
Meyrin, Canton of Geneva, 1217
Tumorzentrum ZeTuP Rapperswil-Jona
Rapperswil, Canton of St. Gallen, 8640
Tumor- und Brustzentrum ZeTuP Sankt Gallen
Sankt Gallen, Canton of St. Gallen, 9000
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
OnkoZentrum Zürich AG
Zurich, 8038
Thailand5 sites
Rajavithi Hospital
Bangkok, Ratchathewi District, 10400
King Chulalongkorn Memoiral Hospsital
Bangkok, 10330
Ramathibodi Hopsital
Bangkok, 10400
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110
Maharaj Nakorn Chiang Mai Hospital
Muang Chiangmai, Chiangmai, 50200
Italy3 sites
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Torre, Roma, 00133
Ospedale Di Circolo E Fondazione Macchi
Varese, 21100
United Kingdom3 sites
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Northern Centre for Cancer Treatment
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Loom Dene
Radlett, Hertfordshire, WD7 8AA
India2 sites
Indraprastha Apollo Hospital
New Delhi, 110076
Apollo Cancer Institute, Apollo Speciality Hospital
Teynampet, Chennai, 600018
Egypt1 site
Cairo Oncology Center (Cairo Cure)
Mohandeseen, Cairo Governorate, 12655
About this study
Official title: 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Abemaciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY2835219
Administered orally.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763604
- Sponsor's protocol ID
- 17088
- Other IDs
- I3Y-MC-Y001
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2018
- Last updated
- 16 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Named Patient Use Program to Provide Abemaciclib for the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03763604
- Acronym / sponsor ID
- 17088
- Conditions
- Metastatic Breast Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibAlso: LY2835219Administered orally. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
160 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abemaciclib in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 160 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 160 sites in Spain, Australia, South Korea, Taiwan, South Africa and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.