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    Summary
    EudraCT Number:2016-004586-67
    Sponsor's Protocol Code Number:CBYL719X2402
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-004586-67
    A.3Full title of the trial
    A phase II, multicenter, open-label, two-cohort, noncomparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after CDK 4/6 inhibitor treatment
    Estudio fase II, abierto, multicéntrico, con dos cohortes de tratamiento, no comparativo, para evaluar la eficacia y la seguridad de alpelisib más fulvestrant o más letrozol, en pacientes con cáncer de mama avanzado (CMA) receptor hormonal (RH) positivo, HER2-negativo, y con mutación PIK3CA, que han progresado durante o después del tratamiento con un inhibidor de CDK4/6
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2- negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant
    Estudio que evalúa la eficacia y la seguridad de alpelisib más fulvestrant o más letrozol, basado en terapia endocrina previa, en pacientes con cáncer de mama avanzado, con mutación PIK3CA que han progresado durante o después del tratamiento con un inhibidor de CDK4/6
    A.3.2Name or abbreviated title of the trial where available
    BYLieve
    A.4.1Sponsor's protocol code numberCBYL719X2402
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493 3064464
    B.5.5Fax number+3493 3064615
    B.5.6E-maileecc.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlpelisib
    D.3.2Product code BYL719
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALPELISIB
    D.3.9.1CAS number 1217486-61-7
    D.3.9.2Current sponsor codeBYL719
    D.3.9.4EV Substance CodeSUB180707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlpelisib
    D.3.2Product code BYL719
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALPELISIB
    D.3.9.1CAS number 1217486-61-7
    D.3.9.2Current sponsor codeBYL719
    D.3.9.4EV Substance CodeSUB180707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hormone receptor positive, HER2-negative advanced breast cancer
    Cáncer de mama avanzado, HER2 negativo y HR positivo.
    E.1.1.1Medical condition in easily understood language
    breast cancer
    Cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A (alpelisib in combination with fulvestrant) and cohort B (alpelisib in combination letrozole) among patients with HR+, HER2-negative aBC harboring a PIK3CA mutation who have progressed on or after CDK 4/6 inhibitor combination with an AI or fulvestrant
    El objetivo principal es evaluar el porcentaje de pacientes que están vivos sin progresión de la enfermedad a los 6 meses, basado en la evaluación del investigador local según los RECIST v1.1 en la cohorte A (alpelisib en combinación con fulvestrant) y en la cohorte B (alpelisib en combinación con letrozol) en pacientes con CMA HR+, HER2-negativo portador de una mutación PIK3CA, cuya enfermedad haya progresado durante o después de la combinación de un inhibidor de CDK4/6 con un IA o con fulvestrant.
    E.2.2Secondary objectives of the trial
    To assess PFS based on local investigator assessment for each cohort

    To assess PFS on next-line treatment (PFS2) for each cohort

    To assess overall response rate (ORR) and clinical benefit rate (CBR) based on local investigator assessment for each cohort

    To assess duration of response (DOR) in patients with confirmed complete response (CR) or PR for each cohort.

    To evaluate the safety and tolerability of the combination for each cohort
    - Evaluar la supervivencia libre de progresión (SLP) con evaluación del investigador local, en cada cohorte.
    - Evaluar la SLP con el tratamiento de siguiente línea (SLP2), en cada cohorte
    - Evaluar la tasa de respuesta global (TRG) y la tasa de beneficio clínico (TBC), basado en la evaluación del investigador local, en cada cohorte
    - Evaluar la duración de la respuesta (DR) en pacientes con respuesta completa (RC) o respuesta parcial (RP) confirmadas, en cada cohorte
    - Evaluar la seguridad y la tolerabilidad de la combinación, en cada cohort
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is male or female 18 years or older
    - Patient is identified PIK3CA mutant status
    - Patient has confirmed HER2-negative advanced breast cancer (aBC)
    -Patient must be diagnosed with aBC with documented progression on or after CDK 4/6 treatment (adjuvant or metastatic setting)
    - Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
    - Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
    - ECOG function of greater or equal to 2
    - Patient has adequate bone marrow function
    - Patient has adequate liver and renal function
    - Pacientes hombres o mujeres postmenopáusicas ≥ 18 años.
    - Pacientes con tejido de tumor suficiente para el análisis del estado de mutación de PIK3CA por un laboratorio designado por Novartis. Se recomienda proporcionar una muestra de tumor recogida después de la progresión o recurrencia más reciente.
    - Pacientes con estado de mutación de PIK3CA identificado, determinado por un laboratorio designado por Novartis
    - Pacientes con un CMA HER2-negativo confirmado. HER2-negativo se define como una prueba de hibridización in situ negativa o un estado en el análisis inmunohistoquímico (IHC) de 0, 1+ o 2+.
    - Pacientes con CMA diagnosticado, con evidencia documentada de progresión durante o después de tratamiento con un inhibidor de CDK 4/6. Nota: El inhibidor de CDK4/6 ha de ser el último régimen de tratamiento previo al inicio del estudio. Se permiten pacientes que recibieron una quimioterapia previa para el CMA (en el marco metastásico o adyuvante). El número máximo de terapias previas para el CMA o el CMM se limita a dos. Los pacientes deberán haberse recuperado a grado 1 o mejor de cualquier acontecimiento adverso (excepto alopecia) relacionado con la terapia previa antes de entrar en el estudio. Para los pacientes varones, no se requiere tratamiento previo con IA.
    - Pacientes con cáncer de mama (CM) ER+ y/o PgR+ histológicamente o citológicamente confirmado.
    - Pacientes con enfermedad medible, es decir, por lo menos una lesión medible según los criterios RECIST v1.1 o si no existe enfermedad medible, al menos deberá estar presente una lesión ósea predominantemente lítica.
    - Pacientes con estado funcional del ECOG ≤ 2.
    - Pacientes con función de la médula ósea adecuada.
    E.4Principal exclusion criteria
    - patient has received prior treatment with any PI3K inhibitors
    - patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
    -Patient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer
    -Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
    -History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
    -Bilateral diffuse lymphangitis carcinomatosis
    -Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
    • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
    • Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as
    determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
    -Patient with severe liver impairment (Child Pugh score B/C)
    -Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
    -Patient has documented pneumonitis which is active and requiring treatment
    - Pacientes que hayan recibido tratamiento previo con cualquier inhibidor de PI3K.
    - Pacientes con diabetes mellitus clínicamente manifiesta o con diabetes mellitus inducida por esteroides documentada
    - Pacientes con una enfermedad maligna concurrente o con una enfermedad maligna dentro de los 3 años del periodo de selección del estudio, con la excepción de cáncer cutáneo no melanoma, carcinoma escamoso o basal, adecuadamente tratado, o cáncer de cuello uterino curativamente extirpado.
    - Pacientes que hayan recibido radioterapia ≤ 4 semanas o radiación de campo limitado para paliación ≤ 2 semanas antes de la inclusión, y que no se hayan recuperado a grado 1 o mejor de los efectos secundarios relacionados con dicha terapia (con la excepción de alopecia).
    - Pacientes que hayan recibido corticosteroides ≤ 2 semanas antes del inicio del tratamiento.
    - Carcinomatosis linfangítica bilateral difusa
    - Antecedentes de pancreatitis aguda dentro de un año de la selección o antecedentes médicos previos de pancreatitis
    - Pacientes con deterioro de la función GI o enfermedad GI que pueda influir en la absorción de las medicaciones del estudio.
    - Pacientes con neumonitis documentada
    - Pacientes que hayan sido tratados con fármacos que se conoce que son inhibidores o inductores potentes de la isoenzima CYP3A (rifabutina, rifampicina, claritromicina, ketoconazol, itraconazol, voriconazol, ritonavir, telitromicina) dentro de los últimos 5 días antes de entrar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients who are alive without disease progression
    Porcentaje de pacientes vivos libres de progresión de la enfermedad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of first dose to approximately 6 months
    Fecha de la primera dosis hasta aproximadamente 6 meses después.
    E.5.2Secondary end point(s)
    Progression free survival (PFS) for each cohort

    Progression free survival (PFS) on next line treatment PFS2) for each cohort

    Percentage of participants Overall response rate (ORR) for each cohort

    Percentage of participants with clinical benefit rate (CBR) for each cohort

    Duration of response (DOR)

    Further secondary objectives and details are described in the protocol
    - Evaluar la supervivencia libre de progresión (SLP) con evaluación del investigador local, en cada cohorte.
    - Evaluar la SLP con el tratamiento de siguiente línea (SLP2), en cada cohorte
    - Evaluar la tasa de respuesta global (TRG) y la tasa de beneficio clínico (TBC), basado en la evaluación del investigador local, en cada cohorte
    - Evaluar la duración de la respuesta (DR) en pacientes con respuesta completa (RC) o respuesta parcial (RP) confirmadas, en cada cohorte
    - Evaluar la seguridad y la tolerabilidad de la combinación, en cada cohorte
    E.5.2.1Timepoint(s) of evaluation of this end point
    date of first dose to up to approximately 25 months

    Date of first dose to date of first documented progression up to approximately 25 months

    Date of first dose and up to approximately 25 months

    Date of first dose and up to approximately 25 months

    Date of first documented response to first documented progression or death up to approximately 25 months
    Desde la primera dosis hasta aproximadamente 25 meses después.

    Desde la fecha de la primera dosis hasta la primera progresión documentada hasta la aproximadamente 25 meses.

    Desde la primera dosis hasta aproximadamente 25 meses después.

    Desde la primera dosis hasta aproximadamente 25 meses después.

    Desde fecha de la primera respuesta documentada hasta la primera progresión documentada o aproximadamente 25 meses.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Bulgaria
    Canada
    Chile
    France
    Germany
    India
    Israel
    Italy
    Japan
    Mexico
    Netherlands
    Singapore
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The primary analysis for each cohort will be performed when all patients included in the corresponding cohort experienced progression, discontinued early or 6 months after the last patient has started treatment. The final analysis will be performed 18 months after the last patient has started treatment. Unless otherwise mentioned, all analyses will be performed separately for each cohort. This applies to all countries
    El análisis primario para cada cohorte se realizará cuando todos los pacientes incluidos en la correspondiente cohorte hayan experimentado progresión, hayan discontinuado prematuramente o 6 meses depués del inicio de tratamiento del paciente. El análisis final se realizará 18 meses después de que el último paciente haya empezado el tratamiento. A no ser que se indique lo contrario, todos los análisis se realizarán por separado para cada uno de los cohorts.
    Esto aplica para todos los paises.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If alpelisib is not commercially available and reimbursed in a participating country by the time the study is completed (18 months after LPFV), Novartis will have a transition plan in place to ensure that patients have equivalent access without delays in treatment.
    Si alpelisib no está comercializado y reembolsado en un país participante en la fecha en la que el estudio finalice (18 meses después de la última visita del último paciente), Novartis tendrá un plan de transición para asegurar que los pacientes tengan acceso al tratamiento sin retrasos.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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