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    Summary
    EudraCT Number:2017-000419-17
    Sponsor's Protocol Code Number:AFT-38
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-22
    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 number2017-000419-17
    A.3Full title of the trial
    A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
    Ensayo de fase III, aleatorizado y abierto para evaluar la eficacia y la seguridad de palbociclib + tratamiento anti-HER2 + tratamiento endocrino frente a tratamiento anti-HER2 + tratamiento endocrino tras el tratamiento de inducción para el cáncer de mama metastásico positivo para receptores hormonales (HR+)/positivo para HER2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbocicilb, to treat Metastatic Breast Cancer (PATINA)
    Ensayo Clínico aleatorizado y abierto de terapia dirigida con palbocliclib para el tratamiento del cáncer de mama metastásico (PATINA)
    A.3.2Name or abbreviated title of the trial where available
    PATINA
    PATINA
    A.4.1Sponsor's protocol code numberAFT-38
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02947685
    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 SponsorAlliance Foundation Trials, LLC
    B.1.3.4CountryUnited States
    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 supportPfizer, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlliance Foundation Trials, LLC
    B.5.2Functional name of contact pointSenior Program Manager
    B.5.3 Address:
    B.5.3.1Street Address221 Longwood Avenue; Room 108
    B.5.3.2Town/ cityBoston
    B.5.3.3Post code02215
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16175257522
    B.5.5Fax number+16177328576
    B.5.6E-mailjlanzillotti@alliancefoundationtrials.org
    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 Yes
    D.2.1.1.1Trade name IBRANCE 125mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Labs, Division of Pfizer, Inc, NY, NY 10017
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIBRANCE
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.1CAS number 571190-30-2
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    D.2.1.1.1Trade name IBRANCE 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Labs, Division of Pfizer, Inc, NY, NY 10017
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIBRANCE
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.1CAS number 571190-30-2
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 Yes
    D.2.1.1.1Trade name IBRANCE 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Labs, Division of Pfizer, Inc, NY, NY 10017
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIBRANCE
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPALBOCICLIB
    D.3.9.1CAS number 571190-30-2
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    HER2 Positive Breast Cancer
    Estrogen Receptor Positive Breast Cancer
    Cáncer de mama HER2 positivo
    Cáncer de mama receptor de estrógenos positivo
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Cancer
    Cáncer de mama metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy in prolonging PFS in participants with hormone receptor-positive, HER2+ metastatic breast cancer who have not received any prior treatment beyond induction treatment in this setting
    El objetivo principal de este estudio es demostrar que la combinación de palbociclib con tratamiento anti-HER2 más tratamiento endocrino es mejor que el tratamiento con anti-HER2 más tratamiento endocrino a la hora de prolongar la SSP en los participantes con cáncer de mama metastásico positivo para receptores hormonales y HER2+ que no hayan recibido ningún tratamiento previo más allá del tratamiento de inducción en este contexto.
    E.2.2Secondary objectives of the trial
    1. To compare measures of tumor control (including PFS, OR, CBR, DOR) between the treatment arms
    2. To compare median overall survival and overall survival probabilities at 3-years and 5-years between the treatment groups
    3. To compare safety and tolerability between the treatment arms
    4. To compare the incidence of CNS metastasis between the treatment arms
    5. To compare patient reported time to symptom progression as assessed by the FACT-B TOI-PFB
    6. To compare patient reported breast cancer specific health related quality of life (HRQOL) and general health status.
    1. Comparar las medidas de control del tumor (incluidas la SSP, la SG, la TBC y la DdR) entre los grupos de tratamiento.
    2. Comparar la mediana de la supervivencia global y las probabilidades de supervivencia global a los 3 y los 5 años entre los grupos de tratamiento.
    3. Comparar la seguridad y la tolerabilidad entre los grupos de tratamiento.
    4. Comparar la incidencia de metástasis en el SNC entre los grupos de tratamiento.
    5. Comparar el tiempo transcurrido hasta la progresión de los síntomas notificado por el paciente, evaluado mediante el FACT-B TOI-PFB.
    6. Comparar la calidad de vida relacionada con la salud (CdVRS) notificada por el paciente específica para el cáncer de mama y el estado de salud general.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent obtained prior to any study specific assessments and procedures
    2. Age ≥18 years (or per national guidelines)
    3. Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer.
    4. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.
    5. Sites must be able to submit a representative formalin-fixed paraffin-embedded (FFPE) tumor tissue block (preferred) from primary breast or metastatic site (archival) OR at least 15 freshly cut unstained slides from such a block, along with a pathology report documenting HER2 positivity and hormone receptor positivity.
    6. Sites should be willing to submit a representative tumor specimen obtained from metastatic disease if clinically feasible. This is a recommended but optional research biopsy.
    Inclusion Criteria (Randomization)
    7. Signed informed consent obtained prior to any study specific assessments and procedures
    8. Age ≥ 18 years (or per national guidelines)
    9. ECOG performance status 0-1
    10. Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.
    11. Serum or urine pregnancy test must be negative within 7 days of randomization in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential and male patients randomized into the study must use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib if they are in Arm A. Adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository).
    12. Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy regimen to NCI CTCAE version 4.0 Grade ≤1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion) 3-6 weeks between last dose of chemotherapy–anti-HER2therapy and randomization are allowed. Endocrine therapy could start before study randomization.
    13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    14. Evidence of (a) personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study before any study specific activity is performed.

    *See full inclusión criteria in protocol
    1. Consentimiento informado firmado obtenido antes de realizar cualquier evaluación o procedimiento específicos del estudio.
    2. Edad ≥18 años (o según las directrices nacionales).
    3. Los participantes deben padecer cáncer de mama invasivo metastásico o no susceptible a resección o a radioterapia con propósito curativo confirmado histológicamente. No se requiere la documentación histológica del cáncer de mama metastásico/recidivante si existen signos inequívocos de recidiva del cáncer de mama.
    4. Los pacientes deben padecer cáncer de mama metastásico HER2+ y positivo para receptores hormonales (ER+ y/o PR+) confirmado histológicamente. Las mediciones de RE, RP y HER2 se deben realizar de acuerdo con las directrices del centro, en unas instalaciones aprobadas por la CLIA en los EE. UU. o en laboratorios certificados en las regiones que no pertenezcan a los EE. UU. Los valores de corte para las tinciones positivas/negativas deben estar de acuerdo con las directrices actuales de la ASCO/CAP (Sociedad Estadounidense de Oncología Clínica/Colegio de Patólogos Estadounidenses).
    5. Los centros deben poder enviar un bloque de tejido tumoral representativo fijado con formol e incluido en parafina (FFIP) (preferentemente) del tumor de mama primario o del área metastásica (de archivo) O al menos 15 cortes sin teñir junto con un informe de anatomía patológica que documente el resultado positivo para HER2 y para receptores hormonales.
    6. Los centros deberán estar dispuestos a enviar una muestra representativa del tumor obtenida de las metástasis, si es clínicamente factible. Esta es una biopsia de investigación recomendada pero opcional.
    7. Consentimiento informado firmado obtenido antes de realizar ninguna evaluación ni procedimiento específicos del estudio.
    8. Edad ≥18 años (o según las directrices nacionales).
    9. Estado funcional del ECOG 0-1.
    10. Los pacientes deben ser capaces y estar dispuestos a tragar y retener el medicamento oral y no presentar un trastorno que pueda interferir en la absorción entérica.
    11. En las mujeres en edad fértil, se debe obtener una prueba de embarazo en suero y orina negativa en los 7 días previos a la aleatorización. No es necesario realizar la prueba de embarazo antes de la aleatorización en las pacientes que se consideren posmenopáusicas, según se determine mediante la práctica local, o que se hayan sometido a ovariectomía bilateral, histerectomía total o ligadura bilateral de trompas. Las mujeres en edad fértil y los pacientes varones distribuidos al azar en el estudio deben utilizar métodos anticonceptivos adecuados durante el desarrollo del protocolo de tratamiento y en los 6 meses posteriores al último tratamiento con palbociclib si se encuentran en el Grupo A. Los métodos anticonceptivos adecuados se definen como una forma altamente eficaz (es decir, abstinencia, esterilización masculina o femenina O) dos formas eficaces (p. ej., DIU no hormonal y preservativo/capuchón oclusivo con espuma/gel/película/crema/
    supositorio espermicidas) de anticoncepción.
    12. Resolución de todos los efectos tóxicos agudos de la inducción anterior con la pauta de quimioterapia con anti-HER2 hasta un grado ≤1 según la versión 4.0 de los CTCAE del NCI (excepto para la alopecia u otras toxicidades que no se consideren un riesgo para la seguridad del paciente, a criterio del investigador). Se permiten entre 3 y 6 semanas entre la última dosis de quimioterapia con anti-HER2 y la aleatorización. El tratamiento endocrino se puede iniciar antes de la aleatorización en el estudio.
    13. Estar dispuesto y tener la capacidad de cumplir con las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio.
    14. Presentar un documento de consentimiento informado firmado y fechado por el paciente indicando que se ha informado al paciente (o a un representante legal del mismo) de todos los aspectos relevantes del estudio antes de realizar ninguna actividad específica del mismo.

    *Ver todos los criterios de inclusión en el protocolo
    E.4Principal exclusion criteria
    1. Concurrent therapy with other Investigational Products.
    2. Prior therapy with any CDK inhibitor.
    3. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
    4. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization.
    5. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.
    6. Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry.
    7. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib.
    8. QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.
    9. Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis
    1. Tratamiento simultáneo con otros productos en fase de investigación.
    2. Tratamiento previo con algún inhibidor de la CDK.
    3. Antecedentes de reacciones alérgicas atribuidas a compuestos de origen químico o biológico similares a palbociclib.
    4. Pacientes que reciban cualquier medicamento o sustancia que sean inhibidores o inductores potentes de las isoenzimas del CYP3A en los 7 días anteriores a la aleatorización.
    5. Enfermedad actual no controlada, incluidas, entre otras, infecciones activas o en curso, insuficiencias cardiacas congestivas sintomáticas, anginas de pecho inestables, arritmias cardiacas, diabetes o enfermedades psiquiátricas/situaciones sociales que puedan limitar el cumplimiento de los requisitos del estudio. La capacidad para cumplir los requisitos del estudio la debe evaluar cada investigador en el momento de la selección antes de participar en el estudio.
    6. Independientemente del método anticonceptivo utilizado, las mujeres embarazadas o en edad fértil que no presenten una prueba de embarazo negativa (en suero u orina) en los 7 días anteriores a la aleatorización serán excluidas de este estudio, ya que se desconoce el efecto de palbociclib sobre el feto en desarrollo. Antes de la incorporación al estudio se debe interrumpir la lactancia.
    7. Los pacientes que se estén sometiendo a un tratamiento antirretroviral de combinación, es decir, aquellos que den positivo para el VIH, no son aptos para el estudio debido a la posibilidad de interacciones farmacocinéticas o a una mayor inmunodepresión con palbociclib.
    8. Intervalo QTc >480 ms, síndrome de Brugada o antecedentes conocidos de prolongación del intervalo QTc o Torsade de Pointes (taquicardia ventricular en entorchado).
    9. Pacientes con antecedentes clínicamente significativos de enfermedades hepáticas, incluida la hepatitis vírica u otras formas conocida de hepatitis, alcoholismo actual o cirrosis.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) as assessed by the Investigator
    Supervivencia sin progresión (SSP) evaluada por el investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    E.5.2Secondary end point(s)
    1. Overall Survival (OS)
    2. 3-year and 5-year survival probabilities
    3. Objective response (OR: CR or PR)
    4. Duration of response (DOR)
    5. Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks)
    6. Safety: Type, incidence, severity (as graded by the NCI CTCAE v. 4.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities
    7. Patient Reported Outcomes: Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status
    1. Supervivencia global (SG).
    2. Probabilidades de supervivencia a los 3 y los 5 años.
    3. Respuesta objetiva (RO: RC o RP).
    4. Duración de la respuesta (DdR).
    5. Tasa de beneficio clínico (TBC: RC o RP o EE ≥24 semanas).
    6. Seguridad: tipo, incidencia, intensidad (clasificada mediante la versión 4.0 de los CTCAE del NCI), gravedad y atribución de los AA y cualquier anomalía analítica a los medicamentos del estudio.
    7. Resultados notificados por el paciente: tiempo hasta la progresión de los síntomas (FACT-B PFB-TOI), calidad de vida relacionada con la salud específica para el cáncer de mama y estado general de salud.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be assessed at 24 months
    Todos los criterios de valoración secundarios se evaluarán a los 24 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia anti HER2 con trastuzumab + pertuzumab y terapia endocrina
    Anti-HER2 therapy with trastuzumab + pertuzumab and endocrine therapy
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Australia
    Germany
    Italy
    New Zealand
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Study duration will be for 5 years after the last patient is randomized, regardless of time to progression. Last follow-up for patient is expected to be May 2024 and study close out activities are expected to be completed by August 2024
    La duración del estudio será de 5 años después de la randomización del último paciente independientemente del tiempo hasta progresión. La última visita de seguimiento se espera en Mayo 2024 y el cierre del estudio en Agosto 2024
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects incapable of giving consent personally may authorize an authorized representative to provide consent
    Los pacientes incapaces de otorgar consentimiento personalmente pueden autorizar a un representante legal para otorgar consentimiento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 496
    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)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Fondazione Michelangelo
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation German Breast Group (GBG) Forschungs GmbH
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation The Australia and New Zealand Breast Cancer Trials Group
    G.4.3.4Network Country Australia
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation PrECOG, LLC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-11
    P. End of Trial
    P.End of Trial StatusOngoing
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