Clinical trial • Phase III • Oncology
LY3484356 for Breast cancer
Phase III trial of LY3484356 for Breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-02-2024
- First CTIS Authorization Date
- 27-03-2024
Trial design
Randomised, open-label, investigator’s choice endocrine therapy (arm b): fulvestrant or exemestane (dose/schedule not specified in provided data).-controlled Phase III trial in Austria, Netherlands, Greece and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Investigator’s Choice Endocrine Therapy (Arm B): fulvestrant or exemestane (dose/schedule not specified in provided data).
- Biomarker Stratified
- True, ESR1 mutation detected population
- Target Sample Size
- 611
Eligibility
Recruits 611 Vulnerable population selected (isVulnerablePopulationSelected: true). No specific consent/assent procedures or minor-assent details are provided in the available JSON..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). No specific consent/assent procedures or minor-assent details are provided in the available JSON.
Inclusion criteria
- {"criterion_text":"- Participants must have HR+ HER2- breast cancer"}
- {"criterion_text":"- Participants must have cancer that is advanced or has spread to another part of the body"}
- {"criterion_text":"- Participants must have already received a drug that blocks the production of estrogen"}
- {"criterion_text":"- Participants must have adequate body organ function"}
- {"criterion_text":"- Participants must be in fair to good health"}
- {"criterion_text":"- Participants must be able to swallow capsules/tablets"}
Exclusion criteria
- {"criterion_text":"- Participants must not have received chemotherapy or some targeted therapies for advanced breast cancer"}
- {"criterion_text":"- Participants must not have cancer that has spread to the brain that has not been treated or is causing symptoms"}
- {"criterion_text":"- Participants must not have another serious medical condition"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Investigator-assessed PFS (between Arm A and Arm B) in the ITT population","definition_or_measurement_approach":"Progression-free survival assessed by investigator (investigator-assessed PFS) in the intent-to-treat (ITT) population."}
- {"endpoint_text":"- Investigator-assessed PFS (between Arm A and Arm B) in the ESR1-mutation detected population","definition_or_measurement_approach":"Progression-free survival assessed by investigator (investigator-assessed PFS) in the population with ESR1 mutation detected."}
- {"endpoint_text":"- Investigator-assessed PFS(between Arm C and Arm A) in the ITT population","definition_or_measurement_approach":"Progression-free survival assessed by investigator (investigator-assessed PFS) in the ITT population comparing Arm C and Arm A."}
Recruitment
- Planned Sample Size
- 611
- Recruitment Window Months
- 64
- Consent Approach
- Informed consent materials (subject information and ICF) are provided; multiple language versions and country-specific ICFs are present in the documents list (examples include ENG, FR, DE, ES, NL, GR, IT, BEFR, BEDU). Specifics on assent are not provided. Separate ICFs for pregnant participants/partners are present in the document list.
Methods
- Greenphire LLC - Patient Screening, Recruitment, and/or Retention (role listed in sponsor third parties).
- Praxis Communications LLC - Patient Screening, Recruitment, and/or Retention (role listed in sponsor third parties).
- Other third parties listed with sponsor duties include laboratory, CRO and vendor organisations noted in the dossier (roles provided as sponsorDuties codes or values in the source JSON).
Geography
- Total Number Of Sites
- 52
- Total Number Of Participants
- 263
Austria
- Latest Decision Or Authorization Date
- 15-04-2024
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Medical University of Graz
- Department Name
- Department of Obstetrics and Gynecology
- Contact Person Name
- Vassiliki Kolovetsiou-Kreiner
- Contact Person Email
- vassiliki.kolovetsiou@medunigraz.at
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Department of Internal Medicine III
- Contact Person Name
- Lukas Weiss
- Contact Person Email
- lu.weiss@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Obstetrics and Gynecology, Division of General Gynecology and Gynecologic Oncology
- Contact Person Name
- Christian Singer
- Contact Person Email
- christian.singer@meduniwien.ac.at
Netherlands
- Latest Decision Or Authorization Date
- 27-03-2024
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Universiteit Maastricht
- Department Name
- Oncology
- Contact Person Name
- Maaike de Boer
- Contact Person Email
- maaike.de.boer@mumc.nl
- Site Name
- Frisius MC
- Department Name
- Oncology
- Contact Person Name
- Lisanne Hamming
- Contact Person Email
- lisanne.hamming@mcl.nl
Greece
- Latest Decision Or Authorization Date
- 20-05-2024
- Number Of Sites
- 6
- Number Of Participants
- 29
Sites
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Clinic of Medical Oncology
- Contact Person Name
- Eleni Timotheadou
- Contact Person Email
- timotheadoue@gmail.com
- Site Name
- Athens Medical Center S.A.
- Department Name
- Oncology Department
- Contact Person Name
- Sofia Baka
- Contact Person Email
- bakasofia@hotmail.com
- Site Name
- St Savas Hospital
- Department Name
- 2nd Department of Internal Medicine - Oncology
- Contact Person Name
- Dimitrios Tryfonopoulos
- Contact Person Email
- tryfonopoulos@hotmail.com
- Site Name
- Athens Medical Center S.A. (Pylea)
- Department Name
- 3rd department of Oncology
- Contact Person Name
- Konstantinos Papazisis
- Contact Person Email
- k.papazisis@oncomedicare.com
- Site Name
- Alexandra Hospital
- Department Name
- Oncology Department, University Clinic of Therapeutics
- Contact Person Name
- Flora Zagouri
- Contact Person Email
- florazagouri@yahoo.co.uk
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Internal Medicine-Oncology Clinic
- Contact Person Name
- Dimitrios Mavroudis
- Contact Person Email
- medoncsec@med.uoc.gr
Germany
- Latest Decision Or Authorization Date
- 05-04-2024
- Number Of Sites
- 7
- Number Of Participants
- 19
Sites
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Senologie/ Brustzentrum
- Principal Investigator Name
- Sherko Kümmel
- Principal Investigator Email
- s.kuemmel@kem-med.com
- Contact Person Name
- Sherko Kümmel
- Contact Person Email
- s.kuemmel@kem-med.com
- Site Name
- Onkologiezentrum Donauwörth
- Contact Person Name
- Bastian Fleischmann
- Contact Person Email
- b.fleischmann_stu@onko-medeor.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Frauenklinik Brustzentrum
- Principal Investigator Name
- Nadia Harbeck
- Principal Investigator Email
- nadia.harbeck@med.uni-muenchen.de
- Contact Person Name
- Nadia Harbeck
- Contact Person Email
- nadia.harbeck@med.uni-muenchen.de
- Site Name
- RKH Klinken Ludwigsburg-Bietigheim gGmbH
- Department Name
- Klinik für Geburtshilfe und Frauenheilkunde
- Contact Person Name
- Claudia Annette Hänle
- Contact Person Email
- claudia.haenle@rkh-gesundheit.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Gynäkologie und Geburtshilfe, Studienzentrale
- Contact Person Name
- Marion Tina van Mackelenbergh
- Contact Person Email
- marion.vanmackelenbergh@uksh.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Klinik für Gynäkologie und Geburtshilfe
- Principal Investigator Name
- Peter A Fasching
- Principal Investigator Email
- peter.fasching.studien@uk-erlangen.de
- Contact Person Name
- Peter A Fasching
- Contact Person Email
- peter.fasching.studien@uk-erlangen.de
- Site Name
- Agaplesion Frankfurter Diakonie Kliniken gGmbH
- Department Name
- Brustzentrum
- Principal Investigator Name
- Marc Thill
- Principal Investigator Email
- marc.thill@agaplesion.de
- Contact Person Name
- Marc Thill
- Contact Person Email
- marc.thill@agaplesion.de
Belgium
- Latest Decision Or Authorization Date
- 15-04-2024
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology
- Principal Investigator Name
- Philippe Aftimos
- Principal Investigator Email
- philippe.aftimos@hubruxelles.be
- Contact Person Name
- Philippe Aftimos
- Contact Person Email
- philippe.aftimos@hubruxelles.be
- Site Name
- Vitaz
- Department Name
- Oncology
- Contact Person Name
- Ines Deleu
- Contact Person Email
- ines.deleu@vitaz.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Principal Investigator Name
- Patrick Neven
- Principal Investigator Email
- patrick.neven@uzleuven.be
- Contact Person Name
- Patrick Neven
- Contact Person Email
- patrick.neven@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Oncology
- Contact Person Name
- Hannelore Denys
- Contact Person Email
- hannelore.denys@ugent.be
- Site Name
- UZ Brussel
- Department Name
- Oncology
- Contact Person Name
- Christel Fontaine
- Contact Person Email
- christel.fontaine@uzbrussel.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Oncology
- Contact Person Name
- Laure Nuytemans
- Contact Person Email
- laure.nuytemans@azgroeninge.be
Italy
- Latest Decision Or Authorization Date
- 11-04-2024
- Number Of Sites
- 7
- Number Of Participants
- 24
Sites
- Site Name
- Careggi University Hospital
- Department Name
- SOD Radioterapia
- Contact Person Name
- Lorenzo Livi
- Contact Person Email
- lorenzo.livi@unifi.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Dipartimento di Medicina Clinica e Chirurgia
- Contact Person Name
- Mario Giuliano
- Contact Person Email
- m.giuliano@unina.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia 2
- Contact Person Name
- Valentina Guarneri
- Contact Person Email
- valentina.guarneri@iov.veneto.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Oncologia Medica 2
- Contact Person Name
- Lucia Del Mastro
- Contact Person Email
- lucia.delmastro@hsanmartino.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Oncologia Clinica Sperimentale di Senologia
- Contact Person Name
- Michelino De Laurentiis
- Contact Person Email
- delauren@breastunit.org
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- SCIENZE DELLA SALUTE DELLA DONNA E DEL BAMBINO E DI SANITÀ PUBBLICA
- Contact Person Name
- Ida Paris
- Contact Person Email
- ida.paris@policlinicogemelli.it
- Site Name
- Istituto Oncologico Veneto (additional listed site)
Spain
- Latest Decision Or Authorization Date
- 02-04-2024
- Number Of Sites
- 12
- Number Of Participants
- 82
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Begoña Bermejo de las Heras
- Principal Investigator Email
- begobermejo@gmail.com
- Contact Person Name
- Begoña Bermejo de las Heras
- Contact Person Email
- begobermejo@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Maria Fernandez Abad
- Principal Investigator Email
- mariafernandezabad@hotmail.com
- Contact Person Name
- Maria Fernandez Abad
- Contact Person Email
- mariafernandezabad@hotmail.com
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Oncology
- Principal Investigator Name
- Josefina Cruz Jurado
- Principal Investigator Email
- jcruzjurado@gmail.com
- Contact Person Name
- Josefina Cruz Jurado
- Contact Person Email
- jcruzjurado@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Cristina Arqueros Nuñez
- Principal Investigator Email
- carqueros@santpau.cat
- Contact Person Name
- Cristina Arqueros Nuñez
- Contact Person Email
- carqueros@santpau.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Cristina Saura
- Principal Investigator Email
- csaura@vhio.net
- Contact Person Name
- Cristina Saura
- Contact Person Email
- csaura@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Ruiz Borrego
- Principal Investigator Email
- ruizsabater@gmail.com
- Contact Person Name
- Manuel Ruiz Borrego
- Contact Person Email
- ruizsabater@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Jose Angel Garcia Saenz
- Principal Investigator Email
- jgsaenz@salud.madrid.org
- Contact Person Name
- Jose Angel Garcia Saenz
- Contact Person Email
- jgsaenz@salud.madrid.org
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Oncology
- Principal Investigator Name
- Isabel Blancas
- Principal Investigator Email
- isabelblancas@hotmail.com
- Contact Person Name
- Isabel Blancas
- Contact Person Email
- isabelblancas@hotmail.com
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- Oncology
- Principal Investigator Name
- Santiago Gonzalez Santiago
- Principal Investigator Email
- santigsanti@gmail.com
- Contact Person Name
- Santiago Gonzalez Santiago
- Contact Person Email
- santigsanti@gmail.com
- Site Name
- Hospital Quironsalud Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Antonio Llombart Cussac
- Principal Investigator Email
- allombart1@yahoo.com
- Contact Person Name
- Antonio Llombart Cussac
- Contact Person Email
- allombart1@yahoo.com
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Oncology
- Principal Investigator Name
- Serafin Morales Murillo
- Principal Investigator Email
- serafinmorales01@gmail.com
- Contact Person Name
- Serafin Morales Murillo
- Contact Person Email
- serafinmorales01@gmail.com
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncology
- Principal Investigator Name
- Alejandro Martinez Bueno
- Principal Investigator Email
- amartinez@oncorosell.com
- Contact Person Name
- Alejandro Martinez Bueno
- Contact Person Email
- amartinez@oncorosell.com
France
- Latest Decision Or Authorization Date
- 15-04-2024
- Number Of Sites
- 9
- Number Of Participants
- 67
Sites
- Site Name
- Centre Regional Lutte Contre Le Cancer
- Department Name
- Medical Oncology
- Contact Person Name
- Laura Somme
- Contact Person Email
- l.bender@icans.eu
- Site Name
- Besancon University Hospital Center
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Mansi
- Principal Investigator Email
- lmansi@chu-besancon.fr
- Contact Person Name
- Laura Mansi
- Contact Person Email
- lmansi@chu-besancon.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Medical Oncology
- Principal Investigator Name
- Thomas Grellety
- Principal Investigator Email
- tgrellety@ch-cotebasque.fr
- Contact Person Name
- Thomas Grellety
- Contact Person Email
- tgrellety@ch-cotebasque.fr
- Site Name
- Institut Curie (Paris)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francois Clement Bidard
- Principal Investigator Email
- francois-clement.bidard@curie.fr
- Contact Person Name
- Francois Clement Bidard
- Contact Person Email
- francois-clement.bidard@curie.fr
- Site Name
- Institut Curie (Saint-Cloud)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francois Clement Bidard
- Principal Investigator Email
- francois-clement.bidard@curie.fr
- Contact Person Name
- Francois Clement Bidard
- Contact Person Email
- francois-clement.bidard@curie.fr
- Site Name
- Centre De Cancerologue Du Grand Montpellier
- Department Name
- Medical Oncology
- Principal Investigator Name
- Cristian Villanueva
- Principal Investigator Email
- cvillanueva@oncoclem.org
- Contact Person Name
- Cristian Villanueva
- Contact Person Email
- cvillanueva@oncoclem.org
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Medical Oncology
- Principal Investigator Name
- Vincent Massard
- Principal Investigator Email
- v.massard@nancy.unicancer.fr
- Contact Person Name
- Vincent Massard
- Contact Person Email
- v.massard@nancy.unicancer.fr
- Site Name
- Clinique Victor Hugo
- Department Name
- Medical Oncology
- Principal Investigator Name
- Yoann Pointreau
- Principal Investigator Email
- essaispointreau@i-l-c.fr
- Contact Person Name
- Yoann Pointreau
- Contact Person Email
- essaispointreau@i-l-c.fr
- Site Name
- Polyclinique De Blois
- Department Name
- Unité de Recherche Clinique La Cerisaie
- Principal Investigator Name
- Philippe Laplaige
- Principal Investigator Email
- dr.laplaige@wanadoo.fr
- Contact Person Name
- Philippe Laplaige
- Contact Person Email
- dr.laplaige@wanadoo.fr
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 1 (responsibility details not provided in JSON)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties codes: 10 (responsibility details not provided in JSON)
- Name
- Macrostat (Shanghai) Clinical Research Co. Ltd.
- Responsibilities
- sponsorDuties codes: 10 (responsibility details not provided in JSON)
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: 4 (no textual duty provided)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 10 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 4 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Macrostat (Shanghai) Clinical Research Co. Ltd.","duties_or_roles":"sponsorDuties codes: 10 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Techdata Service Company LLC","duties_or_roles":"sponsorDuties codes: 10 (no textual duty provided)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"sponsorDuties codes: 4 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Patient Screening, Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Brightech International LLC","duties_or_roles":"sponsorDuties codes: 10 (no textual duty provided)","organisation_type":"Health care"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: 4 (no textual duty provided)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 6 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Multiple sponsor duties including codes 1,12,15,2,5 and text: '(Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices)'","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"sponsorDuties codes: 4 (no textual duty provided)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- LY3484356 (Imlunestrant)
- Active Substance
- LY3484356
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Investigational (prodAuthStatus=1 in source data)
- Investigational Product Name
- ABEMACICLIB
- Active Substance
- Abemaciclib
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Authorised (prodAuthStatus=2 in source data)
- Investigational Product Name
- FULVESTRANT
- Active Substance
- Fulvestrant
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- IM/Injection (solution for injection)
- Authorisation Status
- Authorised (prodAuthStatus=2 in source data)
- Investigational Product Name
- EXEMESTANE
- Active Substance
- Exemestane
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Authorised (prodAuthStatus=2 in source data)
- Combination Treatment
- Yes
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