Clinical trial • Phase II • Oncology
INAVOLISIB for Endocrine-resistant hormone receptor-positive, HER2-negative advanced breast cancer | Advanced breast cancer with chromosome 8p loss and without PIK3CA mutation
Phase II trial of INAVOLISIB for Endocrine-resistant hormone receptor-positive, HER2-negative advanced breast cancer | Advanced breast cancer with chromos…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Endocrine-resistant hormone receptor-positive, HER2-negative advanced breast cancer | Advanced breast cancer with chromosome 8p loss and without PIK3CA mutation
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-11-2025
- First CTIS Authorization Date
- 23-03-2026
Trial design
Randomised, placebo plus ribociclib plus fulvestrant (comparator arm: placebo + ribociclib + fulvestrant); investigational arm: inavolisib plus ribociclib plus fulvestrant. doses and schedules not specified in metadata.-controlled Phase II trial in France, Germany, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo plus Ribociclib plus Fulvestrant (comparator arm: Placebo + Ribociclib + Fulvestrant); investigational arm: Inavolisib plus Ribociclib plus Fulvestrant. Doses and schedules not specified in metadata.
- Biomarker Stratified
- True, biomarker: absence of PIK3CA mutation (PIK3CAnmd) and presence of heterozygous chromosome 8p loss (chr8p loss)
- Target Sample Size
- 36
Eligibility
Recruits 36 Vulnerable population selected. Country-specific subject information sheets and informed consent forms are provided (documents listed), including specific ICFs for pregnant patients, pregnancy partner, newborn and infant; informed consent obtained using these ICFs (country-specific versions). Assent procedures are not specified in the available metadata..
- Vulnerable Population
- Vulnerable population selected. Country-specific subject information sheets and informed consent forms are provided (documents listed), including specific ICFs for pregnant patients, pregnancy partner, newborn and infant; informed consent obtained using these ICFs (country-specific versions). Assent procedures are not specified in the available metadata.
Inclusion criteria
- {"criterion_text":"- Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n- Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as ≥1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)\n- Patients must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen.\n- Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)\n- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)"}
Exclusion criteria
- {"criterion_text":"- Metaplastic breast cancer (BC)\n- Radiotherapy within 2 weeks before randomization\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- Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible\n- Any history of leptomeningeal disease or carcinomatous meningitis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Investigator-Assessed Confirmed ORR","definition_or_measurement_approach":"Investigator-assessed confirmed objective response rate (ORR) as main efficacy endpoint; measured as investigator-assessed confirmed ORR per trial objective and RECIST v1.1 as applicable."}
Secondary endpoints
- {"endpoint_text":"- PFS","definition_or_measurement_approach":"Progression-Free Survival (PFS)"}
- {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall Survival (OS)"}
- {"endpoint_text":"- Investigator-assessed DOR","definition_or_measurement_approach":"Investigator-assessed Duration of Response (DOR)"}
- {"endpoint_text":"- Investigator-assessed CBR","definition_or_measurement_approach":"Investigator-assessed Clinical Benefit Rate (CBR)"}
- {"endpoint_text":"- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; incidence and severity captured and compared by treatment arm."}
- {"endpoint_text":"- Change from baseline in targeted vital signs","definition_or_measurement_approach":"Change from baseline in specified vital sign measurements"}
- {"endpoint_text":"- Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in specified clinical laboratory parameters"}
- {"endpoint_text":"- Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities as assessed through use of the National Cancer Institute (NCI) Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument","definition_or_measurement_approach":"Patient-reported symptomatic toxicities measured using the NCI PRO-CTCAE instrument (presence, frequency, severity, interference)"}
- {"endpoint_text":"- 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":"PRO endpoint: proportion reporting each response option for FACT-G GP5 item by arm and timepoint"}
- {"endpoint_text":"- Change from baseline/worsening 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":"Changes from baseline in PRO-CTCAE measures and FACT-G GP5 item"}
Recruitment
- Digital Remote Recruitment
- True, social media recruitment material documented (K2 social media post).
- Planned Sample Size
- 36
- Recruitment Window Months
- 56
- Consent Approach
- Informed consent obtained using subject information sheets and informed consent forms (L1_SIS and ICF documents). Country-specific ICFs are provided for Member States (documents listed for France, Germany, Italy, Spain, Poland). Specific ICFs are available for pregnant patients, pregnancy partners, newborns and infants. Consent is provided by the participant; details on assent are not specified in the metadata.
Methods
- Social media post (recruitment material) — document: K2_Recruitment material_Social Media Post_CO46274
- Country-specific recruitment arrangements documented (K1 recruitment arrangements documents listed for multiple Member States)
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 44
France
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 69
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Principal Investigator Name
- Elie El Rassy
- Principal Investigator Email
- elie.el-rassy@gustaveroussy.fr
- Contact Person Name
- Elie El Rassy
- Contact Person Email
- elie.el-rassy@gustaveroussy.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mathilde SAINT-GHISLAIN
- Principal Investigator Email
- m-saintghislain@o-lambret.fr
- Contact Person Name
- Mathilde SAINT-GHISLAIN
- Contact Person Email
- m-saintghislain@o-lambret.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Medical Oncology
- Principal Investigator Name
- William JACOT
- Principal Investigator Email
- william.jacot@icm.unicancer.fr
- Contact Person Name
- William JACOT
- Contact Person Email
- william.jacot@icm.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Olivier TREDAN
- Principal Investigator Email
- olivier.tredan@lyon.unicancer.fr
- Contact Person Name
- Olivier TREDAN
- Contact Person Email
- olivier.tredan@lyon.unicancer.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Principal Investigator Name
- Florence DALENC
- Principal Investigator Email
- dalenc.florence@iuct-oncopole.fr
- Contact Person Name
- Florence DALENC
- Contact Person Email
- dalenc.florence@iuct-oncopole.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alexandre TASSIN DE NONNEVILLE
- Principal Investigator Email
- tassindenonnevillea@ipc.unicancer.fr
- Contact Person Name
- Alexandre TASSIN DE NONNEVILLE
- Contact Person Email
- tassindenonnevillea@ipc.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 10-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 41
- Number Of Sites
- 8
- Number Of Participants
- 6
Sites
- Site Name
- Franziskus Hospital Harderberg
- Department Name
- MVZ I der Niels-Stensen-Kliniken Zentrum für Internistische Onkologie und Hämatologie
- Principal Investigator Name
- Kerstin Lüdtke-Heckenkamp
- Principal Investigator Email
- kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de
- Contact Person Name
- Kerstin Lüdtke-Heckenkamp
- Contact Person Email
- kerstin.luedtke-heckenkamp@niels-stensen-kliniken.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Gynäkologie und Geburtsmedizin
- Principal Investigator Name
- Elmar Stickeler
- Principal Investigator Email
- estickeler@ukaachen.de
- Contact Person Name
- Elmar Stickeler
- Contact Person Email
- estickeler@ukaachen.de
- Site Name
- Luisenkrankenhaus GmbH & Co. KG
- Department Name
- N.A.
- Principal Investigator Name
- Athina Kostara
- Principal Investigator Email
- info@gynonco.de
- Contact Person Name
- Athina Kostara
- Contact Person Email
- info@gynonco.de
- Site Name
- Foundation Medicine GmbH
- Department Name
- Foundation Medicine GmbH (testing site)
- Principal Investigator Name
- Ina Mackey (née Vogl)
- Principal Investigator Email
- imackey@foundationmedicine.com
- Contact Person Name
- Ina Mackey (née Vogl)
- Contact Person Email
- imackey@foundationmedicine.com
- 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
- Contact Person Email
- carlo.fremd@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Frauenheilkunde und Geburtshilfe
- Principal Investigator Name
- Ann-Kathrin Bittner
- Principal Investigator Email
- Ann-Kathrin.Bittner@uk-essen.de
- Contact Person Name
- Ann-Kathrin Bittner
- Contact Person Email
- Ann-Kathrin.Bittner@uk-essen.de
- 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
- Contact Person Email
- Andreas.hartkopf@med.uni-tuebingen.de
- Site Name
- MVZ I der Niels-Stensen-Kliniken Zentrum für Internistische Onkologie und Hämatologie (duplicate listing resolved)
Italy
- Earliest CTIS Part Ii Submission Date
- 25-02-2026
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 34
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica 1
- Principal Investigator Name
- Claudio Vernieri
- Principal Investigator Email
- claudio.vernieri@istitutotumori.mi.it
- Contact Person Name
- Claudio Vernieri
- Contact Person Email
- claudio.vernieri@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francesco Pantano
- Principal Investigator Email
- f.pantano@policlinicocampus.it
- Contact Person Name
- Francesco Pantano
- Contact Person Email
- f.pantano@policlinicocampus.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology
- 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
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- SC 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
- Contact Person Email
- m.delaurentiis@istitutotumori.na.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
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC Oncologia
- Principal Investigator Name
- Rita De Sanctis
- Principal Investigator Email
- rdesanctis@asst-pg23.it
- Contact Person Name
- Rita De Sanctis
- Contact Person Email
- rdesanctis@asst-pg23.it
- Site Name
- Additional listed Italian site
Spain
- Earliest CTIS Part Ii Submission Date
- 08-03-2026
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 23
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Principal Investigator Name
- Pablo Tolosa Ortega
- Principal Investigator Email
- pablotolosa_7@hotmail.com
- Contact Person Name
- Pablo Tolosa Ortega
- Contact Person Email
- pablotolosa_7@hotmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncología
- 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 Universitario Ramon Y Cajal
- Department Name
- Oncología
- Principal Investigator Name
- Elena Lopez Miranda
- Principal Investigator Email
- elemiranda@hotmail.com
- Contact Person Name
- Elena Lopez Miranda
- Contact Person Email
- elemiranda@hotmail.com
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Oncología
- Principal Investigator Name
- Maria Isabel Blancas López-Barajas
- Principal Investigator Email
- iblancas@ugr.es
- Contact Person Name
- Maria Isabel Blancas López-Barajas
- Contact Person Email
- iblancas@ugr.es
- Site Name
- Hospital Universitario Clinico De Valencia
- Department Name
- Oncología
- 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 Clinic De Barcelona
- Department Name
- Oncología
- Principal Investigator Name
- María Jesús Vidal Losada
- Principal Investigator Email
- MJVIDAL@clinic.cat
- Contact Person Name
- María Jesús Vidal Losada
- Contact Person Email
- MJVIDAL@clinic.cat
- Site Name
- Additional listed Spanish site
Poland
- Earliest CTIS Part Ii Submission Date
- 06-03-2026
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- I Oddział Onkologii Klinicznej z Chemioterapią Dzienną
- Principal Investigator Name
- Agata Chrzanowska-Kapica
- Principal Investigator Email
- kozdra@cozl.pl
- Contact Person Name
- Agata Chrzanowska-Kapica
- Contact Person Email
- kozdra@cozl.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Onkologii
- Principal Investigator Name
- Ewa Kalinka
- Principal Investigator Email
- stefaniak.patrycja1@gmail.com
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- stefaniak.patrycja1@gmail.com
- Site Name
- Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
- Department Name
- Oddział Onkologii Klinicznej im. dr Ewy Pileckiej z pododdziałem chemioterapii dziennej
- 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
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Oddział Onkologii Klinicznej i Chemioterapii
- Principal Investigator Name
- Aleksandra Łacko
- Principal Investigator Email
- onkocwbk@dcopih.pl
- Contact Person Name
- Aleksandra Łacko
- Contact Person Email
- onkocwbk@dcopih.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Collaborative CRO
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sponsor duties code 4 (central laboratory services); contact: Jaclyne.Lybek@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Collaborative CRO","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Sponsor duties code 4 (testing-related services); contact: jolien.beyers@cellcarta.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"Central Lab Biomarker Samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"IxRS Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Central lab Biomarker Samples","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"Sponsor duties code 4 (testing-related services)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- INAVOLISIB
- Active Substance
- INAVOLISIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 9 mg
- Investigational Product Name
- RIBOCICLIB
- Active Substance
- RIBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 600 mg
- Investigational Product Name
- FULVESTRANT
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- INTRAMUSCULAR INJECTION
- Maximum Dose
- 500 mg
- Investigational Product Name
- Inavolisib placebo
- Modality
- Other
- Combination Treatment
- Yes
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