Clinical trial • Phase III • Oncology
ABEMACICLIB for Breast cancer (HR+, HER2-) | Advanced/metastatic breast cancer
Phase III trial of ABEMACICLIB for Breast cancer (HR+, HER2-) | Advanced/metastatic breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer (HR+, HER2-) | Advanced/metastatic breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-01-2024
- First CTIS Authorization Date
- 26-02-2024
Trial design
Randomised, abemaciclib plus fulvestrant versus placebo plus fulvestrant; investigational abemaciclib product: verzenios 50 mg film-coated tablets (active substance abemaciclib); fulvestrant (fulvestrant) intramuscular; placebo to match abemaciclib-controlled Phase III trial across 39 sites in Poland, Denmark, France and others.
- Randomised
- Yes
- Comparator
- Abemaciclib plus Fulvestrant versus Placebo plus Fulvestrant; investigational abemaciclib product: Verzenios 50 mg film-coated tablets (active substance ABEMACICLIB); fulvestrant (FULVESTRANT) intramuscular; placebo to match abemaciclib
- Target Sample Size
- 193
- Trial Duration For Participant
- 1080
Eligibility
Recruits 193 adults.
Inclusion criteria
- {"criterion_text":"- Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer\n- Have radiologic evidence of disease progression or recurrence either On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer\n- Must be deemed appropriate for treatment with ET\n- If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression\n- Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)\n- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)\n- Have adequate renal, hematologic, and hepatic organ function\n- Must be able to swallow capsules/tablets"}
Exclusion criteria
- {"criterion_text":"- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis\n- Have symptomatic or untreated central nervous system metastasis\n- Have received any systemic therapy between disease recurrence/progression and study screening\n- Have received more than 1 line of therapy for advanced or metastatic disease.\n- Have received prior chemotherapy for metastatic breast cancer (MBC)\n- Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 193
- Recruitment Window Months
- 68
- Consent Approach
- Informed consent documented via Subject Information Sheets and Informed Consent Forms (multiple L1/L2 ICF documents listed). ICFs and subject information materials are available in multiple languages (examples in the document list include French, Hungarian, Italian, Spanish, Greek, Czech and variants for BE languages). Specifics on assent, who provides consent for vulnerable participants, or age-specific consent forms are not specified in the available text.
Methods
- Site-based recruitment through participating hospitals and oncology clinics (lists of planned sites provided)
- Patient recruitment activities conducted/managed by Publicis Healthcare Communications Group Limited (role: Patient recruitment)
- Use of Greenphire ClinCard and associated travel/reimbursement support (Greenphire ClinCard materials and messaging templates are listed)
- Invite letters and patient information materials (multiple ICF and subject information documents listed)
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 154
Poland
- Latest Decision Or Authorization Date
- 15-03-2024
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
- Department Name
- Oddzial Onkologii Klinicznej z Odcinkiem Dziennym
- Principal Investigator Name
- Barbara Radecka
- Principal Investigator Email
- brad@onkologia.opole.pl
- Contact Person Name
- Barbara Radecka
- Contact Person Email
- brad@onkologia.opole.pl
Denmark
- Latest Decision Or Authorization Date
- 26-02-2024
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Herlev Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Malgorzata Tuxen
- Principal Investigator Email
- malgorzata.tuxen@regionh.dk
- Contact Person Name
- Malgorzata Tuxen
- Contact Person Email
- malgorzata.tuxen@regionh.dk
- Site Name
- Region Midtjylland
- Department Name
- Kræftklinikken
- Principal Investigator Name
- Julia Kenholm
- Principal Investigator Email
- julikenh@rm.dk
- Contact Person Name
- Julia Kenholm
- Contact Person Email
- julikenh@rm.dk
France
- Latest Decision Or Authorization Date
- 01-03-2024
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- onco-hematologie
- Principal Investigator Name
- Frank PRIOU
- Principal Investigator Email
- frank.priou@chd-vendee.fr
- Contact Person Name
- Frank PRIOU
- Contact Person Email
- frank.priou@chd-vendee.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marc DEBLED
- Principal Investigator Email
- m.debled@bordeaux.unicancer.fr
- Contact Person Name
- Marc DEBLED
- Contact Person Email
- m.debled@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Institut de cancérologie et hématologie
- Principal Investigator Name
- Laura DEIANA
- Principal Investigator Email
- laura.deiana@chu-brest.fr
- Contact Person Name
- Laura DEIANA
- Contact Person Email
- laura.deiana@chu-brest.fr
- Site Name
- L'Hopital Prive Du Confluent
- Department Name
- Service d'oncologie médicale
- Principal Investigator Name
- Dorothee CHOCTEAU-BOUJU
- Principal Investigator Email
- dr.chocteau@groupeconfluent.fr
- Contact Person Name
- Dorothee CHOCTEAU-BOUJU
- Contact Person Email
- dr.chocteau@groupeconfluent.fr
Hungary
- Latest Decision Or Authorization Date
- 29-02-2024
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Oncoradiology
- Principal Investigator Name
- Istvan Sipocz
- Principal Investigator Email
- drsipocz@gmail.com
- Contact Person Name
- Istvan Sipocz
- Contact Person Email
- drsipocz@gmail.com
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Chemotherapy
- Principal Investigator Name
- Balazs Madaras
- Principal Investigator Email
- madaras.balazs@oncol.hu
- Contact Person Name
- Balazs Madaras
- Contact Person Email
- madaras.balazs@oncol.hu
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Zsuzsanna Papai
- Principal Investigator Email
- trial.zspapai@gmail.com
- Contact Person Name
- Zsuzsanna Papai
- Contact Person Email
- trial.zspapai@gmail.com
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Oncoradiology
- Principal Investigator Name
- Zsolt Horvath
- Principal Investigator Email
- horvathzso.study@kmk.hu
- Contact Person Name
- Zsolt Horvath
- Contact Person Email
- horvathzso.study@kmk.hu
Italy
- Latest Decision Or Authorization Date
- 28-02-2024
- Number Of Sites
- 8
- Number Of Participants
- 27
Sites
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Oncology Department
- Principal Investigator Name
- Elena Poletto
- Principal Investigator Email
- elena.poletto@asuiud.sanita.fvg.it
- Contact Person Name
- Elena Poletto
- Contact Person Email
- elena.poletto@asuiud.sanita.fvg.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Michela Palleschi
- Principal Investigator Email
- michela.palleschi@irst.emr.it
- Contact Person Name
- Michela Palleschi
- Contact Person Email
- michela.palleschi@irst.emr.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giampaolo Bianchini
- Principal Investigator Email
- bianchini.giampaolo@hsr.it
- Contact Person Name
- Giampaolo Bianchini
- Contact Person Email
- bianchini.giampaolo@hsr.it
- Site Name
- Azienda USL Toscana Sud Est
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Ilaria Pastina
- Principal Investigator Email
- ilaria.pastina@uslsudest.toscana.it
- Contact Person Name
- Ilaria Pastina
- Contact Person Email
- ilaria.pastina@uslsudest.toscana.it
- Site Name
- Belcolle Hospital
- Department Name
- U.O.C Oncologia
- Principal Investigator Name
- Maria Agnese Fabbri
- Principal Investigator Email
- agnese.fabbri@yahoo.it
- Contact Person Name
- Maria Agnese Fabbri
- Contact Person Email
- agnese.fabbri@yahoo.it
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Davide Quaresmini
- Principal Investigator Email
- d.quaresmini@oncologico.bari.it
- Contact Person Name
- Davide Quaresmini
- Contact Person Email
- d.quaresmini@oncologico.bari.it
- Site Name
- Humanitas Istituto Clinico Catanese S.p.A.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Michele Caruso
- Principal Investigator Email
- michele.caruso@ccocatania.it
- Contact Person Name
- Michele Caruso
- Contact Person Email
- michele.caruso@ccocatania.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giampaolo Bianchini
- Principal Investigator Email
- bianchini.giampaolo@hsr.it
- Contact Person Name
- Giampaolo Bianchini
- Contact Person Email
- bianchini.giampaolo@hsr.it
Czechia
- Latest Decision Or Authorization Date
- 27-02-2024
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Multiscan s.r.o.
- Principal Investigator Name
- Karel Odrazka
- Principal Investigator Email
- odrazka@multiscan.cz
- Contact Person Name
- Karel Odrazka
- Contact Person Email
- odrazka@multiscan.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika onkologie a radioterapie
- Principal Investigator Name
- Iveta Kolarova
- Principal Investigator Email
- iveta.kolarova@fnhk.cz
- Contact Person Name
- Iveta Kolarova
- Contact Person Email
- iveta.kolarova@fnhk.cz
Greece
- Latest Decision Or Authorization Date
- 01-04-2024
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Oncology Department, University Clinic of Therapeutics
- Principal Investigator Name
- Flora Zagouri
- Principal Investigator Email
- florazagouri@yahoo.co.uk
- Contact Person Name
- Flora Zagouri
- Contact Person Email
- florazagouri@yahoo.co.uk
- Site Name
- Athens Medical Center S.A.
- Department Name
- 3rd Department of Oncology
- Principal Investigator Name
- Konstantinos Papazisis
- Principal Investigator Email
- k.papazisis@oncomedicare.com
- Contact Person Name
- Konstantinos Papazisis
- Contact Person Email
- k.papazisis@oncomedicare.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Internal Medicine Clinic-Oncology Department
- Principal Investigator Name
- Angelos Koutras
- Principal Investigator Email
- angkoutr@otenet.gr
- Contact Person Name
- Angelos Koutras
- Contact Person Email
- angkoutr@otenet.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Internal Medicine-Oncology Clinic
- Principal Investigator Name
- Dimitrios Mavroudis
- Principal Investigator Email
- medoncsec@med.uoc.gr
- Contact Person Name
- Dimitrios Mavroudis
- Contact Person Email
- medoncsec@med.uoc.gr
Belgium
- Latest Decision Or Authorization Date
- 26-02-2024
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- Oncology
- Principal Investigator Name
- Didier Verhoeven
- Principal Investigator Email
- didier.verhoeven@klina.be
- Contact Person Name
- Didier Verhoeven
- Contact Person Email
- didier.verhoeven@klina.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Oncology
- Principal Investigator Name
- Annelies Requile
- Principal Investigator Email
- annelies.requile@jessazh.be
- Contact Person Name
- Annelies Requile
- Contact Person Email
- annelies.requile@jessazh.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Oncology
- Principal Investigator Name
- Donatienne Taylor
- Principal Investigator Email
- donatienne.taylor@chuuclnamur.uclouvain.be
- Contact Person Name
- Donatienne Taylor
- Contact Person Email
- donatienne.taylor@chuuclnamur.uclouvain.be
Spain
- Latest Decision Or Authorization Date
- 01-03-2024
- Number Of Sites
- 11
- Number Of Participants
- 58
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Miguel Martin
- Principal Investigator Email
- mmartin@geicam.org
- Contact Person Name
- Miguel Martin
- Contact Person Email
- mmartin@geicam.org
- Site Name
- Salut Sant Joan De Reus
- Department Name
- Oncology
- Principal Investigator Name
- Mireia Mele
- Principal Investigator Email
- mireia.mele@salutsantjoan.cat
- Contact Person Name
- Mireia Mele
- Contact Person Email
- mireia.mele@salutsantjoan.cat
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jose Luis Alonso
- Principal Investigator Email
- josel.alonso2@carm.es
- Contact Person Name
- Jose Luis Alonso
- Contact Person Email
- josel.alonso2@carm.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Principal Investigator Name
- Cristina Reboredo Rendo
- Principal Investigator Email
- cristina.reboredo.rendo@sergas.es
- Contact Person Name
- Cristina Reboredo Rendo
- Contact Person Email
- cristina.reboredo.rendo@sergas.es
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Dolores Torregosa
- Principal Investigator Email
- marilotorre@gmail.com
- Contact Person Name
- Maria Dolores Torregosa
- Contact Person Email
- marilotorre@gmail.com
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alba Gonzalez-Haba
- Principal Investigator Email
- alba.gonzalezehaba@salud-juntaex.es
- Contact Person Name
- Alba Gonzalez-Haba
- Contact Person Email
- alba.gonzalezehaba@salud-juntaex.es
- Site Name
- University Hospital Son Espases
- Department Name
- Oncology
- Principal Investigator Name
- Antonia Perello
- Principal Investigator Email
- antonia.perellom@ssib.es
- Contact Person Name
- Antonia Perello
- Contact Person Email
- antonia.perellom@ssib.es
- Site Name
- Universidad De Navarra
- Department Name
- Medical Oncology
- Principal Investigator Name
- Susana De la Cruz
- Principal Investigator Email
- susana.delacruz.sanchez@navarra.es
- Contact Person Name
- Susana De la Cruz
- Contact Person Email
- susana.delacruz.sanchez@navarra.es
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Medical Oncology
- Principal Investigator Name
- Juan David Cárdenas
- Principal Investigator Email
- juandacardenas@hotmail.com
- Contact Person Name
- Juan David Cárdenas
- Contact Person Email
- juandacardenas@hotmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medical Oncology
- Principal Investigator Name
- Facundo Alberti
- Principal Investigator Email
- facundoalbertivargas@hotmail.com
- Contact Person Name
- Facundo Alberti
- Contact Person Email
- facundoalbertivargas@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Montserrat Muñoz
- Principal Investigator Email
- mmunoz@clinic.cat
- Contact Person Name
- Montserrat Muñoz
- Contact Person Email
- mmunoz@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Eresearchtechnology Inc.
- Responsibilities
- sponsorDuties codes: 6
- Name
- Almac Clinical Services Limited
- Responsibilities
- sponsorDuties codes: 4
- Name
- Q2 Solutions LLC
- Responsibilities
- sponsorDuties codes: 4
- Name
- RWS Life Sciences Inc.
- Responsibilities
- sponsorDuties codes: 6
- Name
- Altasciences Compagnie Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties codes: 10
- Name
- Guardant Health Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Iqvia Rds Inc.
- Responsibilities
- sponsorDuties codes: 1
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"codes: 1, 12, 15 (Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices), 2, 5","organisation_type":"Industry"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Philips Pharma Solutions","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Industry"}
- {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"sponsorDuties codes: 15 (Patient recruitment)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: 15 (Patient recruitment / ClinCard travel/reimbursement support)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Brightech International, LLC","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Industry"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Verzenios 50 mg film-coated tablets
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/18/1307/001)
- Maximum Dose
- 300 mg daily (maxDailyDoseAmount 300 mg)
- Investigational Product Name
- FULVESTRANT
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR
- Route
- INTRAMUSCULAR
- Authorisation Status
- Authorised (product reference SCP15544179)
- Maximum Dose
- 500 mg (maxDailyDoseAmount 500 mg)
- Investigational Product Name
- Placebo to match abemaciclib
- Modality
- Other
- Authorisation Status
- Not applicable
- Combination Treatment
- Yes
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