Clinical trial • Phase III • Oncology
INAVOLISIB for Hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutation
Phase III trial of INAVOLISIB for Hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutation.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutation
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-05-2024
- First CTIS Authorization Date
- 04-07-2024
Trial design
Randomised, placebo plus palbociclib (125 mg, oral, max daily dose listed) and fulvestrant (faslodex 250 mg solution for injection, intramuscular). (investigational arm: inavolisib plus palbociclib and fulvestrant.)-controlled Phase III trial in Portugal, Belgium, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo plus palbociclib (125 mg, oral, max daily dose listed) and fulvestrant (Faslodex 250 mg solution for injection, intramuscular). (Investigational arm: inavolisib plus palbociclib and fulvestrant.)
- Biomarker Stratified
- True, biomarker: PIK3CA mutation
- Target Sample Size
- 233
Eligibility
Recruits 233 Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is handled via subject information and informed consent forms (multiple ICF documents are included in the dossier). No specific assent procedures or additional details for paediatric/assent handling are provided in the available CTIS metadata..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Informed consent is handled via subject information and informed consent forms (multiple ICF documents are included in the dossier). No specific assent procedures or additional details for paediatric/assent handling are provided in the available CTIS metadata.
Inclusion criteria
- {"criterion_text":"- Confirmed diagnosis of HR+/HER2-negative breast cancer\n- Metastatic or Locally Advanced disease not amenable to curative therapy\n- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)\n- Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen\n- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)"}
Exclusion criteria
- {"criterion_text":"- Metaplastic breast cancer\n- Any history of leptomeningeal disease or carcinomatous meningitis\n- Any prior systemic therapy for metastatic breast cancer\n- Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of patients that have received fulvestrant or any selective estrogen receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months\n- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Progression-free survival","definition_or_measurement_approach":"Not specified in the endpoint listing; the main objective states evaluation on the basis of progression-free survival."}
Secondary endpoints
- {"endpoint_text":"- 1. Overall survival","definition_or_measurement_approach":""}
- {"endpoint_text":"- 2. Objective response rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- 3. Best overall response rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- 4. Clinical benefit rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- 5. Duration of response","definition_or_measurement_approach":""}
- {"endpoint_text":"- 6. Time to confirmed deterioration (TTCD) in pain","definition_or_measurement_approach":""}
- {"endpoint_text":"- 7. TTCD in physical function","definition_or_measurement_approach":""}
- {"endpoint_text":"- 8. TTCD in Role Function","definition_or_measurement_approach":""}
- {"endpoint_text":"- 9. TTCD in GHS/HRQoL","definition_or_measurement_approach":""}
- {"endpoint_text":"- 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v5.0 (explicitly stated)."}
- {"endpoint_text":"- 11. Change from baseline in targeted vital signs","definition_or_measurement_approach":""}
- {"endpoint_text":"- 12. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":""}
- {"endpoint_text":"- 13. Change from baseline in ECG parameters","definition_or_measurement_approach":""}
- {"endpoint_text":"- 14. Plasma concentration of inavolisib at specified timepoints","definition_or_measurement_approach":"Measured as plasma concentrations at specified timepoints (PK)."}
- {"endpoint_text":"- 15. Plasma concentration of inavolisib at additional specified timepoints in patients enrolled in China","definition_or_measurement_approach":"Measured as plasma concentrations at additional specified timepoints in China (PK)."}
- {"endpoint_text":"- 16. Plasma concentration of palbociclib at specified timepoints","definition_or_measurement_approach":"Measured as plasma concentrations at specified timepoints (PK)."}
- {"endpoint_text":"- 17. Plasma concentration of fulvestrant at specified timepoints","definition_or_measurement_approach":"Measured as plasma concentrations at specified timepoints (PK)."}
Recruitment
- Planned Sample Size
- 233
- Recruitment Window Months
- 120
- Consent Approach
- Informed consent obtained using subject information and informed consent forms (multiple ICF documents in the dossier). ICF documents are available in multiple languages (examples in dossier filenames: English, French, Dutch, Spanish, Hungarian, Polish, Portuguese, German). Consent is obtained via the documented ICFs (pre-screening and main ICFs present); no specific assent arrangements for minors are provided in the CTIS metadata.
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 91
Portugal
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 04-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Oncologia Médica
- Contact Person Name
- Joana Bordalo Sá
- Contact Person Email
- joana.sa@ipoporto.min-saude.pt
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Oncologia Médica
- Contact Person Name
- Fatima Cardoso
- Contact Person Email
- info@research.fchampalimaud.org
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 05-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- UZ Leuven
- Department Name
- Gynaecologic Oncology
- Contact Person Name
- Patrick Neven
- Contact Person Email
- Patrick.neven@uzleuven.be
Italy
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 29-07-2024
- Processing Time Days
- 45
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Ospedale Santa Maria Annunziata
- Department Name
- Oncology department
- Contact Person Name
- Carlotta Bacci
- Contact Person Email
- carlotta.bacci@uslcentro.toscana.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica 1
- Contact Person Name
- Giulia Bianchi
- Contact Person Email
- giulia.bianchi@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- Medical Oncology Unit
- Contact Person Name
- Daniela Boggiani
- Contact Person Email
- boggiani@ao.pr.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 04-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Onkologiai Kozpont
- Contact Person Name
- Anna Lengyel
- Contact Person Email
- lengyelanna66@freemail.hu
- Site Name
- Budapesti Uzsoki Utcai Korhaz
- Department Name
- Onkoradiologiai Osztaly
- Contact Person Name
- Meszaros Edina
- Contact Person Email
- m.edina@uzsoki.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 18-07-2024
- Processing Time Days
- 34
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka
- Department Name
- Przychodnia Lekarska KOMED, Roman Karaszewski
- Contact Person Name
- Bogusława Karaszewska
- Contact Person Email
- komed.badania@gmail.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
- Department Name
- Centrum Diagnostyki i Leczenia Chorób Piersi
- Contact Person Name
- Michał Jarząb
- Contact Person Email
- michal.jarzab@io.gliwice.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
- Department Name
- Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
- Contact Person Name
- Zbigniew Nowecki
- Contact Person Email
- nowotworypiersi@pib-nio.pl
France
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 24
- Number Of Sites
- 8
- Number Of Participants
- 12
Sites
- Site Name
- Hopital Prive Jean Mermoz
- Department Name
- Medical Oncology
- Contact Person Name
- Olfa Derbel
- Contact Person Email
- o.derbelmermoz@gmail.com
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology
- Contact Person Name
- Charlotte Bellier
- Contact Person Email
- c-bellier@o-lambret.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Medical Oncology
- Contact Person Name
- FLORENCE DALENC
- Contact Person Email
- dalenc.florence@iuct-oncopole.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncology
- Contact Person Name
- William Jacot
- Contact Person Email
- William.Jacot@icm.unicancer.fr
- Site Name
- Polyclinique Bordeaux Nord Aquitaine
- Department Name
- Radiotherapy
- Contact Person Name
- NADINE DOHOLLOU
- Contact Person Email
- n.dohollou@bordeauxnord.com
- Site Name
- Centre Jean Perrin
- Department Name
- Medical Oncology
- Contact Person Name
- MARIE ANGE MOURET REYNIER
- Contact Person Email
- Marie-Ange.MOURET-REYNIER@clermont.unicancer.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Oncology
- Contact Person Name
- Laurence Bouvet
- Contact Person Email
- laurence.venat-bouvet@chu-limoges.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Contact Person Name
- Isabelle Desmoulins
- Contact Person Email
- idesmoulins@cgfl.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Abteilung Gynäkologie
- Contact Person Name
- Angelika Fink
- Contact Person Email
- angelina.fink@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Frauenklinik
- Contact Person Name
- Frederik Marmé
- Contact Person Email
- frederik.marme@umm.de
- Site Name
- Klinikum Mutterhaus der Borromaeerinnen gGmbH
- Department Name
- Hämatologie/Onkologie
- Contact Person Name
- Ameen Aslan
- Contact Person Email
- ameen.aslan@mutterhaus.de
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Department Name
- Gyn. Onk. Frauenklinik, Uniklinikum Heidelberg
- Contact Person Name
- Andreas Schneeweiss
- Contact Person Email
- andreas.schneeweiss@med.uni-heidelberg.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Senologie / Brustzentrum
- Contact Person Name
- Sherko Kümmel
- Contact Person Email
- brustzentrum@kem-med.com
Greece
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 18-09-2024
- Processing Time Days
- 96
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Dimitris Mavroudis
- Contact Person Email
- medoncsec@med.uoc.gr
- Site Name
- St Savas Hospital
- Department Name
- 2nd Department of Medical Oncology
- Contact Person Name
- Dimitrios Tryfonopoulos
- Contact Person Email
- tryfonopoulos@hotmail.com
- Site Name
- Athens Medical Center S.A.
- Department Name
- 3rd Department of Oncology
- Contact Person Name
- Konstantinos Papazisis
- Contact Person Email
- k.papazisis@oncomedicare.com
Spain
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 24
- Number Of Sites
- 17
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Contact Person Name
- José Ángel Garcia Saenz
- Contact Person Email
- jgsaenz@salud.madrid.org
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Contact Person Name
- Sonia Servitja Tormo
- Contact Person Email
- sservitja@psmar.cat
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncology
- Contact Person Name
- Blanca Cantos
- Contact Person Email
- blanca.cantos@salud.madrid.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Rafael Villanueva Vazquez
- Contact Person Email
- ravillanueva@iconcologia.net
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Contact Person Name
- Luis De La Cruz Merino
- Contact Person Email
- ldelacruzmerino@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Contact Person Name
- Joaquin Gavila Gregori
- Contact Person Email
- jgavila@fivo.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Eva Ciruelos Gil
- Contact Person Email
- Eva.ciruelos@gmail.com
- Site Name
- Hospital Clinico De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Montserrat Muñoz Mateu
- Contact Person Email
- mmunoz@clinic.cat
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Oncology
- Contact Person Name
- Josefina Cruz Jurado
- Contact Person Email
- jcruzjurado@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Contact Person Name
- Yolanda Jeréz Gilarranz
- Contact Person Email
- itacayoli@hotmail.com
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncology
- Contact Person Name
- Antonio González
- Contact Person Email
- agonzalezma@unav.es
- Site Name
- Hospital Universitario De Jaen
- Department Name
- Oncology
- Contact Person Name
- Pedro Sanchez Rovira
- Contact Person Email
- oncopsr@yahoo.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Contact Person Name
- Begoña Bermejo De Las Heras
- Contact Person Email
- begobermejo@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Contact Person Name
- Mireia Margeli Vila
- Contact Person Email
- mmargeli@iconcologia.net
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncology
- Contact Person Name
- Antonio González
- Contact Person Email
- agonzalezma@unav.es
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Oncology
- Contact Person Name
- Alvaro Rodriguez Lescure
- Contact Person Email
- onkopinha@gmail.com
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- Oncology
- Contact Person Name
- Cristina Saura
- Contact Person Email
- csaura@vhio.net
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Labcorp Central Laboratory Services S.a.r.l.
- Responsibilities
- Global CRO
- Name
- IQVIA Limited
- Responsibilities
- code 1
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- code 6
- Name
- Parexel International Services India Private Limited
- Responsibilities
- code 11
Third parties
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"code 11","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"Other Third Party Duty; code 3","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- INAVOLISIB
- Active Substance
- INAVOLISIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 9 mg (maxDailyDoseAmount)
- Investigational Product Name
- PALBOCICLIB
- Active Substance
- PALBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 2 (marketingAuthNumber: - relabelled for trial use)
- Maximum Dose
- 125 mg (maxDailyDoseAmount)
- Investigational Product Name
- Faslodex 250 mg solution for injection.
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- INTRAMUSCULAR INJECTION
- Authorisation Status
- prodAuthStatus: 2 (marketingAuthNumber: EU/1/03/269/002)
- Maximum Dose
- 500 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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