Clinical trial • Phase II • Oncology
INAVOLISIB for Early-stage PIK3CA-mutated breast cancer
Phase II trial of INAVOLISIB for Early-stage PIK3CA-mutated breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Early-stage PIK3CA-mutated breast cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-04-2025
- First CTIS Authorization Date
- 01-07-2025
Trial design
open-label, arm a: inavolisib + ribociclib + letrozole; arm b: inavolisib + letrozole; arm c: ribociclib + letrozole-controlled Phase II trial across 16 sites in Spain, Germany.
- Open Label
- Yes
- Comparator
- Arm A: Inavolisib + Ribociclib + Letrozole; Arm B: Inavolisib + Letrozole; Arm C: Ribociclib + Letrozole
- Biomarker Stratified
- True, biomarker: PIK3CA mutation (confirmed by central laboratory testing)
- Target Sample Size
- 76
- Trial Duration For Participant
- 180
Eligibility
Recruits 76 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms are listed (multiple L1_SIS and ICF documents, including a Pregnant Patient ICF). Explicit details on consent/assent procedures or age-specific consent wording are not provided in the available data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms are listed (multiple L1_SIS and ICF documents, including a Pregnant Patient ICF). Explicit details on consent/assent procedures or age-specific consent wording are not provided in the available data.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification\n- Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy\n- Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)\n- Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, assessed locally and defined as ≥ 1% of tumor cells stained positive for ER\n- Documented HER2-negative tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, assessed locally\n- Documented Ki-67 score ≥ 5% as per local assessment\n- Confirmed PIK3CA mutation, as documented through central laboratory testing of a representative formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample"}
Exclusion criteria
- {"criterion_text":"- Stage IV (metastatic) breast cancer\n- Inflammatory breast cancer (cT4d)\n- Bilateral invasive breast cancer\n- History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast\n- Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments)\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":"- Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 grading scale","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v5.0 grading scale; incidence and severity recorded per standard CTCAE assessment."}
- {"endpoint_text":"- Change from baseline in selected clinical laboratory test results","definition_or_measurement_approach":"Change from baseline measurements in selected clinical laboratory tests (laboratory parameters not specified in JSON)."}
- {"endpoint_text":"- Tolerability, as assessed by the overall treatment exposure and the incidence of dose modifications and treatment discontinuation due to adverse events","definition_or_measurement_approach":"Assessment via overall treatment exposure metrics and recording incidence of dose modifications and treatment discontinuations attributable to adverse events."}
Secondary endpoints
- {"endpoint_text":"- Pathologic Complete Response (pCR) rate in breast and axilla (ypT0/Tis ypN0) according to local pathologist assessment following the American Joint Committee on Cancer (AJCC) TNM staging system (Amin et al. 2017; NCCN 2024)","definition_or_measurement_approach":"pCR defined as ypT0/Tis ypN0 assessed by local pathologist per AJCC TNM staging."}
- {"endpoint_text":"- Tumor overall objective response rate (ORR)","definition_or_measurement_approach":"Objective response rate measured as per tumour response criteria (specific criteria not detailed in JSON)."}
- {"endpoint_text":"- Changes in Ki-67 by immunohistochemistry (IHC)","definition_or_measurement_approach":"Ki-67 changes measured by IHC on tumour samples (local assessment indicated elsewhere)."}
- {"endpoint_text":"- Presence, frequency of occurrence, severity, and/or degree of interference with daily function of selected symptomatic treatment toxicities as assessed through use of the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)","definition_or_measurement_approach":"Symptomatic toxicities assessed by NCI PRO-CTCAE instruments capturing presence, frequency, severity and interference with daily function."}
- {"endpoint_text":"- Proportion of participants reporting each response option at each assessment timepoint for treatment side-effect bother single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General (FACT-G)","definition_or_measurement_approach":"Proportion reporting each response option on FACT-G GP5 item at each assessment timepoint."}
- {"endpoint_text":"- Change from baseline/worsening in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of PRO-CTCAE and the FACT-G GP5 item","definition_or_measurement_approach":"Change from baseline/worsening assessed using PRO-CTCAE and FACT-G GP5."}
Recruitment
- Registry Or Advocacy Recruitment
- True, FACIT.Org Inc.
- Planned Sample Size
- 76
- Recruitment Window Months
- 21
- Consent Approach
- Informed consent handled via Subject Information Sheets and Informed Consent Forms (multiple L1_SIS and ICF documents are listed, including a Pregnant Patient ICF). Specific text describing assent, age-specific consent forms or languages available is not provided in the available data.
Methods
- Sites (hospital/clinic) recruitment across participating countries (site list provided for Spain and Germany).
- Third-party patient recruitment and advertising: FACIT.Org Inc., Axon Communications Inc. and other contracted vendors listed under sponsor third parties for recruitment/advertising services.
- Site management support from a Site Management Provider (IQVIA Limited listed with role 'Site Management Provider').
- Central laboratory and testing support (Labcorp Early Development Laboratories Inc.; Labcorp Central Laboratory Services LP; CellCarta for central testing/PIK3CA mutation testing).
- Recruitment arrangements document (K1_Recruitment Arrangements) is listed for publication and presumably details local recruitment approaches.
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 34
Spain
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 14
- Number Of Sites
- 8
- Number Of Participants
- 18
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Sara Lopez-Tarruella Cobo
- Principal Investigator Email
- sara.lopeztarruella@salud.madrid.org
- Contact Person Name
- Sara Lopez-Tarruella Cobo
- Contact Person Email
- sara.lopeztarruella@salud.madrid.org
- 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 12 De Octubre
- Department Name
- Oncology
- 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
- Hospital Universitario De Salamanca
- Department Name
- Oncology
- Principal Investigator Name
- Cesar Rodriguez Sanchez
- Principal Investigator Email
- carodriguez@saludcastillayleon.es
- Contact Person Name
- Cesar Rodriguez Sanchez
- Contact Person Email
- carodriguez@saludcastillayleon.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Principal Investigator Name
- Fernando Henao Carrasco
- Principal Investigator Email
- ferheca@gmail.com
- Contact Person Name
- Fernando Henao Carrasco
- Contact Person Email
- ferheca@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Miriam Arumi de Dios
- Principal Investigator Email
- marumi@vhio.net
- Contact Person Name
- Miriam Arumi de Dios
- Contact Person Email
- marumi@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Tomas Pascual Martinez
- Principal Investigator Email
- topascual@clinic.cat
- Contact Person Name
- Tomas Pascual Martinez
- Contact Person Email
- topascual@clinic.cat
- Site Name
- Hospital (unnamed entry)
Germany
- Earliest CTIS Part Ii Submission Date
- 06-06-2025
- Latest Decision Or Authorization Date
- 01-08-2025
- Processing Time Days
- 56
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Klinik für Gynäkologie und Geburtshilfe
- Principal Investigator Name
- Niklas Gremke
- Principal Investigator Email
- Gremken@staff.uni-marburg.de
- Contact Person Name
- Niklas Gremke
- Contact Person Email
- Gremken@staff.uni-marburg.de
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Department Name
- Sektion Gynäkologische Onkologie
- Principal Investigator Name
- Laura Michel
- Principal Investigator Email
- Laura.Michel@med.uni-heidelberg.de
- Contact Person Name
- Laura Michel
- Contact Person Email
- Laura.Michel@med.uni-heidelberg.de
- Site Name
- HELIOS Kliniken Schwerin GmbH
- Department Name
- Frauenklinik
- Principal Investigator Name
- Nicole Stahl
- Principal Investigator Email
- nicole.stahl2@helios-gesundheit.de
- Contact Person Name
- Nicole Stahl
- Contact Person Email
- nicole.stahl2@helios-gesundheit.de
- Site Name
- St. Vincenz-Krankenhaus GmbH
- Department Name
- Frauen- und Kinderklinik St. Louise
- Principal Investigator Name
- Michael Patrick Lux
- Principal Investigator Email
- M.Lux@vincenz.de
- Contact Person Name
- Michael Patrick Lux
- Contact Person Email
- M.Lux@vincenz.de
- Site Name
- HELIOS Klinikum Berlin-Buch GmbH
- Department Name
- Klinik für Geburtshilfe und Gynäkologie
- Principal Investigator Name
- Michael Untch
- Principal Investigator Email
- michael.untch@helios-gesundheit.de
- Contact Person Name
- Michael Untch
- Contact Person Email
- michael.untch@helios-gesundheit.de
- Site Name
- DBZ Onkologie GmbH
- Department Name
- N.A.
- Principal Investigator Name
- Antje Müller
- Principal Investigator Email
- studienmueller@dasbrustzentrum.de
- Contact Person Name
- Antje Müller
- Contact Person Email
- studienmueller@dasbrustzentrum.de
- 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
- Contact Person Email
- theresa.link@uniklinikum-dresden.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Klinik für Senologie/Brustzentrum
- Principal Investigator Name
- Sherko Kümmel
- Principal Investigator Email
- brustzentrum@kem-med.com
- Contact Person Name
- Sherko Kümmel
- Contact Person Email
- brustzentrum@kem-med.com
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Site Management Provider
- Name
- Perceptive Informatics Inc.
- Name
- Labcorp Early Development Laboratories Inc.
- Name
- Labcorp Central Laboratory Services LP
Third parties
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Site Management Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"Patient Recruitment and Advertising / Promotion Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Patient Recruitment and Advertising / Promotion Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","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
- Investigational Product Name
- RIBOCICLIB
- Active Substance
- RIBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 2
- Maximum Dose
- 400 mg
- Investigational Product Name
- LETROZOLE
- Active Substance
- LETROZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 2
- Maximum Dose
- 2.5 mg
- Combination Treatment
- Yes
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