Clinical trial • Phase III • Oncology

INAVOLISIB for Hormone receptor-positive HER2-negative advanced breast cancer (PIK3CA‑mutated)

Phase III trial of INAVOLISIB for Hormone receptor-positive HER2-negative advanced breast cancer (PIK3CA‑mutated).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hormone receptor-positive HER2-negative advanced breast cancer (PIK3CA‑mutated)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-12-2024
First CTIS Authorization Date
07-04-2025

Trial design

Randomised, experimental arm: inavolisib plus a cdk4/6 inhibitor and letrozole. comparator arm: placebo (inavolisib placebo) plus a cdk4/6 inhibitor and letrozole. dosing information available in product records: inavolisib (max daily dose listed 9 mg), palbociclib (max daily dose listed 125 mg), letrozole (max daily dose listed 2.5 mg). specific schedules not stated in the ctis summary.-controlled Phase III trial across 71 sites in France, Germany, Italy and others.

Randomised
Yes
Comparator
Experimental arm: Inavolisib plus a CDK4/6 inhibitor and letrozole. Comparator arm: Placebo (Inavolisib placebo) plus a CDK4/6 inhibitor and letrozole. Dosing information available in product records: inavolisib (max daily dose listed 9 mg), palbociclib (max daily dose listed 125 mg), letrozole (max daily dose listed 2.5 mg). Specific schedules not stated in the CTIS summary.
Biomarker Stratified
True, PIK3CA mutation (participants must have a study-eligible PIK3CA-mutation)
Target Sample Size
274

Eligibility

Recruits 274 adults.

Inclusion criteria

  • {"criterion_text":"- De-novo hormone receptor-positive (HR +) , HER2- advanced breast cancer (ABC), or, alternatively, relapsed HR + , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy – If a CDK4/6i was included as part of that early breast cancer treatment, progression must not have occurred during or within 1 year of last receipt of the CDK4/6i\n- Confirmation of biomarker eligibility: valid results from either central testing of blood or pre-existing local testing of blood or tumor tissue documenting the presence of a study-eligible PIK3CA-mutation.\n- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n- Men or women of postmenopausal or premenopausal/perimenopausal status\n- For men (and women of pre-/peri-menopausal status: willingness to undergo and maintain treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment\n- Adequate hematologic and organ function within 14 days prior to initiation of study treatment"}

Exclusion criteria

  • {"criterion_text":"- Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer\n- Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., patients with visceral crisis)\n- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n- Inability or unwillingness to swallow pills\n- Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)\n- History of malignancy within 5 years prior to consent, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Time from randomization to the first occurrence of disease progression, as determined by the investigator according to response evaluation criteria in solid tumors, Version 1.1 (RECIST v1.1), or death from any cause (whichever occurs first)","definition_or_measurement_approach":"Time from randomization to first investigator-determined disease progression per RECIST v1.1 or death from any cause (whichever occurs first); investigator-assessed."}

Secondary endpoints

  • {"endpoint_text":"- 1. Time from randomization to death from any cause","definition_or_measurement_approach":"Time from randomization to death from any cause."}
  • {"endpoint_text":"- 2. Investigator-assessed confirmed objective response rate (ORR), defined as the proportion of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Proportion of participants with CR and/or PR confirmed on at least two consecutive assessments ≥4 weeks apart per RECIST v1.1, investigator-assessed."}
  • {"endpoint_text":"- 3. Investigator-assessed duration of response (DOR), defined as the time from the first occurrence of a confirmed objective response to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)","definition_or_measurement_approach":"Time from first confirmed objective response to first investigator-determined progression per RECIST v1.1 or death (whichever occurs first)."}
  • {"endpoint_text":"- 4. Investigator-assessed clinical benefit rate (CBR), defined as the proportion of participants with a CR, PR, and/or stable Disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1","definition_or_measurement_approach":"Proportion of participants with CR, PR, or SD lasting ≥24 weeks per RECIST v1.1, investigator-assessed."}
  • {"endpoint_text":"- 5. Time to confirmed deterioration (TTCD) in pain, defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline held for two consecutive timepoints on the \"worst pain\" item from the Brief Pain Inventory-Short Form (BPI-SF)","definition_or_measurement_approach":"Time from randomization to first documentation of ≥2-point increase from baseline on BPI‑SF 'worst pain' item sustained for two consecutive assessments."}
  • {"endpoint_text":"- 6. TTCD in Physical Function, defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive timepoints on the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Function scale (items 1-5)","definition_or_measurement_approach":"Time from randomization to first documentation of ≥10-point decrease from baseline on EORTC QLQ-C30 Physical Function (items 1–5) sustained for two consecutive assessments."}
  • {"endpoint_text":"- 7. TTCD in Role Function, defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive timepoints on the EORTC QLQ-C30 Role Function scale (items 6 and 7)","definition_or_measurement_approach":"Time from randomization to first documentation of ≥10-point decrease from baseline on EORTC QLQ-C30 Role Function (items 6–7) sustained for two consecutive assessments."}
  • {"endpoint_text":"- 8. TTCD in HRQoL, defined as the time from randomization to the first documentation of a ≥ 10- point decrease from baseline held for two consecutive timepoints on the EORTC QLQ-30 GHS/QoL scale (items 29 and 30)","definition_or_measurement_approach":"Time from randomization to first documentation of ≥10-point decrease from baseline on EORTC QLQ-C30 Global Health Status/QoL (items 29–30) sustained for two consecutive assessments."}
  • {"endpoint_text":"- 9. Incidence and severity of adverse events, with severity determined according to the national cancer institute common terminology criteria for adverse events (NCI CTCAE) v5.0","definition_or_measurement_approach":"Incidence and severity graded per NCI CTCAE v5.0."}
  • {"endpoint_text":"- 10. Change from baseline in targeted vital signs","definition_or_measurement_approach":"Change from baseline in pre-specified vital signs."}
  • {"endpoint_text":"- 11. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in specified clinical laboratory test values."}
  • {"endpoint_text":"- 12. Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities (i.e., diarrhea, nausea, vomiting, decreased appetite, fatigue, mouth sores, rash, muscle pain, joint pain, hot flashes and vaginal dryness), as assessed through use of the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) instrument","definition_or_measurement_approach":"Patient-reported symptomatic toxicities assessed via NCI PRO-CTCAE (presence, frequency, severity, interference with daily activities)."}
  • {"endpoint_text":"- 13. Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side-effect bother single-item General Population, Question 5 (GP5) from the functional assessment of cancer therapy-general questionnaire (FACT-G)","definition_or_measurement_approach":"Proportion reporting each response option to FACT-G GP5 at each assessment, by arm."}
  • {"endpoint_text":"- 14. Change from baseline in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of the PRO-CTCAE and FACT-G GP5 item, respectively","definition_or_measurement_approach":"Change from baseline in PRO-CTCAE symptomatic toxicities and in FACT-G GP5 'treatment side-effect bother'."}

Recruitment

Digital Remote Recruitment
True, social media post document present (K2_Recruitment Material_Social Media Post_WO45654) indicating planned digital/social media recruitment material
Planned Sample Size
274
Recruitment Window Months
69
Consent Approach
Subject information and informed consent forms (L1_SIS and ICF) are provided in the dossier (multiple versions and redacted/unredacted documents listed). Multiple language protocol synopses exist. No explicit assent or age-specific consent text is available in the provided CTIS JSON.

Methods

  • K1_Recruitment arrangements (document titles present in CTIS document list) - general recruitment arrangements document referenced for multiple countries.
  • K2_Recruitment Material_Social Media Post_WO45654 - indicates use of social media as a recruitment channel (document present in dossier).
  • K2_Recruitment material leaflet - indicates use of printed leaflet recruitment materials (document present in dossier).

Geography

Total Number Of Sites
71
Total Number Of Participants
176

France

Earliest CTIS Part Ii Submission Date
17-02-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
374
Number Of Sites
12
Number Of Participants
35

Sites

Site Name
Centre Henri Becquerel
Department Name
Oncologie Médicale
Principal Investigator Name
Marianne LEHEURTEUR
Principal Investigator Email
marianne.leheurteur@chb.unicancer.fr
Contact Person Name
Marianne LEHEURTEUR
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie Médicale
Principal Investigator Name
Florence DALENC
Principal Investigator Email
dalenc.florence@iuct-oncopole.fr
Contact Person Name
Florence DALENC
Site Name
Centre Oscar Lambret
Department Name
Oncologie Médicale
Principal Investigator Name
Coralie PREBET
Principal Investigator Email
investigation@o-lambert.fr
Contact Person Name
Coralie PREBET
Contact Person Email
investigation@o-lambert.fr
Site Name
Institut Curie (Saint-Cloud)
Department Name
Oncologie Médicale
Principal Investigator Name
François-Clément BIDARD
Principal Investigator Email
francois-clement.bidard@curie.fr
Contact Person Name
François-Clément BIDARD
Site Name
Institut De Cancerologie De L Ouest (Saint-Herblain Cedex)
Department Name
Oncologie Médicale
Principal Investigator Name
Mario CAMPONE
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario CAMPONE
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie Médicale
Principal Investigator Name
Nicolas ISAMBERT
Principal Investigator Email
nicolas.isambert@chu-poitiers.fr
Contact Person Name
Nicolas ISAMBERT
Site Name
Institut Gustave Roussy
Department Name
Oncologie Médicale
Principal Investigator Name
CHAYMA BOUSRIH
Principal Investigator Email
chayma.bousrih@gustave.roussy.fr
Contact Person Name
CHAYMA BOUSRIH
Site Name
CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
Department Name
Oncologie Médicale
Principal Investigator Name
Anne-Claire Hardy-Bessard
Principal Investigator Email
ac.hardy@cario-sante.fr
Contact Person Name
Anne-Claire Hardy-Bessard
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie Médicale
Principal Investigator Name
Fanny LE DU
Principal Investigator Email
f.ledu@rennes.unicancer.fr
Contact Person Name
Fanny LE DU
Contact Person Email
f.ledu@rennes.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncologie Médicale
Principal Investigator Name
Mario CAMPONE
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario CAMPONE
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncologie Médicale
Principal Investigator Name
Cristian Villanueva
Principal Investigator Email
villanueva@ccgm.fr
Contact Person Name
Cristian Villanueva
Contact Person Email
villanueva@ccgm.fr
Site Name
Institut Curie (Paris)
Department Name
Oncologie Médicale
Principal Investigator Name
François-Clément BIDARD
Principal Investigator Email
francois-clement.bidard@curie.fr
Contact Person Name
François-Clément BIDARD

Germany

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
364
Number Of Sites
16
Number Of Participants
28

Sites

Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
N.A.
Principal Investigator Name
Rudolf Weide
Principal Investigator Email
weide@invo-koblenz.de
Contact Person Name
Rudolf Weide
Contact Person Email
weide@invo-koblenz.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Sektion Gynäkologische Onkologie
Principal Investigator Name
Carlo Fremd
Principal Investigator Email
carlo.fremd@med.uni-heidelberg.de
Contact Person Name
Carlo Fremd
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Frauenklinik Brustzentrum
Principal Investigator Name
Mustafa Deryal
Principal Investigator Email
m.deryal@caritasklinikum.de
Contact Person Name
Mustafa Deryal
Contact Person Email
m.deryal@caritasklinikum.de
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Brustklinik am Krankenhaus Jerusalem
Principal Investigator Name
Christian Schem
Principal Investigator Email
schem@mammazentrum.eu
Contact Person Name
Christian Schem
Contact Person Email
schem@mammazentrum.eu
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
N.A.
Principal Investigator Name
Johanna Frindte
Principal Investigator Email
j.frindte@kem-med.com
Contact Person Name
Johanna Frindte
Contact Person Email
j.frindte@kem-med.com
Site Name
St. Elisabeth Krankenhaus GmbH
Department Name
Brustzentrum
Principal Investigator Name
Julian Puppe
Principal Investigator Email
Julian.Puppe@hohenlind.de
Contact Person Name
Julian Puppe
Contact Person Email
Julian.Puppe@hohenlind.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Gynäkologie
Principal Investigator Name
Susanne Barrot
Principal Investigator Email
susanne.barrot@uk-halle.de
Contact Person Name
Susanne Barrot
Contact Person Email
susanne.barrot@uk-halle.de
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
N.A.
Principal Investigator Name
Dorothea Fischer
Principal Investigator Email
dorothea.fischer@klinikumevb.de
Contact Person Name
Dorothea Fischer
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Frauenklinik und Geburtshilfe
Principal Investigator Name
Kerstin Pfister
Principal Investigator Email
kerstin.pfister@uniklinik-ulm.de
Contact Person Name
Kerstin Pfister
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Theresa Link
Principal Investigator Email
theresa.link@uniklinikum-dresden.de
Contact Person Name
Theresa Link
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Abteilung für Frauengesundheit
Principal Investigator Name
Andreas Hartkopf
Principal Investigator Email
Andreas.hartkopf@med.uni-tuebingen.de
Contact Person Name
Andreas Hartkopf
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Stephan Seitz
Principal Investigator Email
sseitz@csj.de
Contact Person Name
Stephan Seitz
Contact Person Email
sseitz@csj.de
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Department Name
N.A.
Principal Investigator Name
Andreas Köhler
Principal Investigator Email
dr.koehler@onkologie-langen.de
Contact Person Name
Andreas Köhler
Contact Person Email
dr.koehler@onkologie-langen.de
Site Name
Universitaet Muenster
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Joke Tio
Principal Investigator Email
joke.tio@ukmuenster.de
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Ann-Katrin Bittner
Principal Investigator Email
Ann-Kathrin.Bittner@uk-essen.de
Contact Person Name
Ann-Katrin Bittner
Site Name
Medizinische Hochschule Hannover
Department Name
Abteilung Gynäkologische Onkologie
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
park-simon.tjoung-won@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon

Italy

Earliest CTIS Part Ii Submission Date
19-03-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
345
Number Of Sites
17
Number Of Participants
53

Sites

Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
S.C. Oncologia
Principal Investigator Name
Jennifer Foglietta
Principal Investigator Email
j.foglietta@aospterni.it
Contact Person Name
Jennifer Foglietta
Contact Person Email
j.foglietta@aospterni.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Antonino Musolino
Principal Investigator Email
antonino.musolino@irst.emr.it
Contact Person Name
Antonino Musolino
Contact Person Email
antonino.musolino@irst.emr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Principal Investigator Name
Giulia Valeria Bianchi
Principal Investigator Email
giulia.bianchi@istitutotumori.mi.it
Contact Person Name
Giulia Valeria Bianchi
Site Name
Humanitas Mirasole S.p.A.
Department Name
Breast Oncology Unit
Principal Investigator Name
Carmen Criscitiello
Contact Person Name
Carmen Criscitiello
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
S.C.D.U. Oncologia
Principal Investigator Name
Alessandra Gennari
Principal Investigator Email
alessandra.gennari@med.uniupo.it
Contact Person Name
Alessandra Gennari
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
S.S.D. Oncologia Medica - Zamagni
Principal Investigator Name
Claudio Zamagni
Principal Investigator Email
zamagniclaudio.sper@aosp.bo.it
Contact Person Name
Claudio Zamagni
Contact Person Email
zamagniclaudio.sper@aosp.bo.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. Oncologia, COM
Principal Investigator Name
Federico Piacentini
Principal Investigator Email
federico.piacentini@unimore.it
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Central Hospital Of Bolzano
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Luca Tondulli
Principal Investigator Email
Luca.tondulli@sabes.it
Contact Person Name
Luca Tondulli
Contact Person Email
Luca.tondulli@sabes.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
S.C. Oncologia
Principal Investigator Name
Alberto Zambelli
Principal Investigator Email
azambelli@asst-pg23.it
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
U.O.C. Oncologia Medica
Principal Investigator Name
Grazia Arpino
Principal Investigator Email
grazia.arpino@unina.it
Contact Person Name
Grazia Arpino
Contact Person Email
grazia.arpino@unina.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
U.O.C. Oncologia Clinica Sperimentale di Senologia
Principal Investigator Name
Michelino De Laurentiis
Principal Investigator Email
m.delaurentiis@istitutotumori.na.it
Contact Person Name
Michelino De Laurentiis
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.S.D. Medicina di Precisione in Senologia
Principal Investigator Name
Alessandra Fabi
Principal Investigator Email
alessandra.fabi@policlinicogemelli.it
Contact Person Name
Alessandra Fabi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. 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
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncologia
Principal Investigator Name
Maria Vita Sanò
Principal Investigator Email
mariavita.sano@humanitascatania.it
Contact Person Name
Maria Vita Sanò
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
U.O.C. Oncologia Medica Livorno
Principal Investigator Name
Giacomo Allegrini
Principal Investigator Email
giacomo.allegrini@uslnordovest.toscana.it
Contact Person Name
Giacomo Allegrini
Site Name
Azienda Ospedaliera Sant'anna E San Sebastiano Di Caserta
Department Name
U.O.C. Oncologia Medica a Direzione Universitaria
Principal Investigator Name
Michele Orditura
Principal Investigator Email
michele.orditura@aorncaserta.it
Contact Person Name
Michele Orditura

Spain

Earliest CTIS Part Ii Submission Date
17-03-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
350
Number Of Sites
16
Number Of Participants
35

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Rafael Villanueva Vazquez
Principal Investigator Email
ravillanueva@iconcologia.net
Contact Person Name
Rafael Villanueva Vazquez
Contact Person Email
ravillanueva@iconcologia.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Ramon Colomer Bosch
Principal Investigator Email
rcolomer@seom.org
Contact Person Name
Ramon Colomer Bosch
Contact Person Email
rcolomer@seom.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Eva Ciruelos Gil
Principal Investigator Email
eva.ciruelos@gmail.com
Contact Person Name
Eva Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com
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 Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
Ana Godoy Ortiz
Principal Investigator Email
anagodort@gmail.com
Contact Person Name
Ana Godoy Ortiz
Contact Person Email
anagodort@gmail.com
Site Name
Hospital General Universitario De Elche
Department Name
Oncology
Principal Investigator Name
Alvaro Rodriguez-Lescure
Principal Investigator Email
alescure@geicam.org
Contact Person Name
Alvaro Rodriguez-Lescure
Contact Person Email
alescure@geicam.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Javier Salvador Bofill
Principal Investigator Email
jsalvad2002@yahoo.es
Contact Person Name
Javier Salvador Bofill
Contact Person Email
jsalvad2002@yahoo.es
Site Name
Hospital Universitario De La Princesa
Department Name
Oncology
Principal Investigator Name
Ramon Colomer Bosch
Principal Investigator Email
rcolomer@seom.org
Contact Person Name
Ramon Colomer Bosch
Contact Person Email
rcolomer@seom.org
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Principal Investigator Name
Susana de la Cruz Sanchez
Principal Investigator Email
sdelacrs@navarra.es
Contact Person Name
Susana de la Cruz Sanchez
Contact Person Email
sdelacrs@navarra.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Cristina Saura Manich
Principal Investigator Email
csaura@vhio.net
Contact Person Name
Cristina Saura Manich
Contact Person Email
csaura@vhio.net
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Principal Investigator Name
Cristina Saavedra Serrano
Principal Investigator Email
cristina.saavedra@iobmadrid.com
Contact Person Name
Cristina Saavedra Serrano
Site Name
Hospital Universitario Basurto
Department Name
Oncology
Principal Investigator Name
Elena Galve Calvo
Principal Investigator Email
elena.galvecalvo@osakidetza.eus
Contact Person Name
Elena Galve Calvo
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 Infanta Leonor
Department Name
Oncology
Principal Investigator Name
Ramon Colomer Bosch
Principal Investigator Email
rcolomer@seom.org
Contact Person Name
Ramon Colomer Bosch
Contact Person Email
rcolomer@seom.org
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Joaquin Gavila Gregori
Principal Investigator Email
jogagre@hotmail.com
Contact Person Name
Joaquin Gavila Gregori
Contact Person Email
jogagre@hotmail.com
Site Name
Hospital Universitario 12 De Octubre (additional site entry)
Department Name
Oncology
Principal Investigator Name
Eva Ciruelos Gil
Principal Investigator Email
eva.ciruelos@gmail.com
Contact Person Name
Eva Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
336
Number Of Sites
10
Number Of Participants
25

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział Onkologii Klinicznej i Chemioterapii
Principal Investigator Name
Aleksandra Łacko
Principal Investigator Email
badaniakliniczne@dcopih.pl
Contact Person Name
Aleksandra Łacko
Contact Person Email
badaniakliniczne@dcopih.pl
Site Name
Przychodnia Lekarska KOMED Roman Karaszewski
Principal Investigator Name
Bogusława Karaszewska
Principal Investigator Email
komed.badania@gmail.com
Contact Person Name
Bogusława Karaszewska
Contact Person Email
komed.badania@gmail.com
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Natalia Ścirka-Wołczko
Principal Investigator Email
nscirka@cozl.pl
Contact Person Name
Natalia Ścirka-Wołczko
Contact Person Email
nscirka@cozl.pl
Site Name
Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie
Department Name
Oddział Kliniczny Onkologii Klinicznej i Chemioterapii
Principal Investigator Name
Joanna Streb
Principal Investigator Email
onkologia@narutowicz.krakow.pl
Contact Person Name
Joanna Streb
Contact Person Email
onkologia@narutowicz.krakow.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Principal Investigator Name
Zbigniew Nowecki
Principal Investigator Email
nowotworypiersi@pib-nio.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@pib-nio.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
Principal Investigator Name
Anna Szafryna-Kliwicka
Principal Investigator Email
clinicaltrials@wco.pl
Contact Person Name
Anna Szafryna-Kliwicka
Contact Person Email
clinicaltrials@wco.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej
Principal Investigator Name
Bogumiła Czartoryska-Arłukowicz
Principal Investigator Email
bco@onkologia.bialystok.pl
Contact Person Name
Bogumiła Czartoryska-Arłukowicz
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Principal Investigator Name
Ewa Kalinka
Principal Investigator Email
ewakalinka@wp.pl
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Mruk-Med I Sp. z o.o.
Principal Investigator Name
Andrzej Mruk
Principal Investigator Email
badaniakliniczne.mrukmed@gmail.com
Contact Person Name
Andrzej Mruk

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Third parties

  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Central Laboratory Provider, Biomarker Labs","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Central Laboratory Provider","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Central Laboratory Provider, Pharmacokinetics Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IXRS Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"Central Laboratory Provider, Pharmacokinetics Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Central Imaging Provider","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
INAVOLISIB
Active Substance
INAVOLISIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
1
Maximum Dose
9 mg (maxDailyDoseAmount listed)
Investigational Product Name
Inavolisib placebo
Modality
Other
Investigational Product Name
PALBOCICLIB (IBRANCE)
Active Substance
PALBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
125 mg (maxDailyDoseAmount listed)
Investigational Product Name
LETROZOLE
Active Substance
LETROZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
2.5 mg (maxDailyDoseAmount listed)
Investigational Product Name
RIBOCICLIB
Active Substance
RIBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
600 mg (maxDailyDoseAmount listed)
Combination Treatment
Yes

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