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    Summary
    EudraCT Number:2014-005181-30
    Sponsor's Protocol Code Number:AFT-05/ABCSG-42/BIG_14-03
    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:2016-01-22
    Trial results View 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 number2014-005181-30
    A.3Full title of the trial
    PALbociclib CoLlaborative Adjuvant Study:
    A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer
    PALLAS (PALbociclib CoLlaborative Adjuvant Study):
    Ensayo de fase III aleatorizado de palbociclib con tratamiento endocrino adyuvante estándar frente a monoterapia con tratamiento endocrino adyuvante estándar en cáncer de mama primario con receptores hormonales positivos (RH+) y HER2-negativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PALbociclib CoLlaborative Adjuvant Study:
    A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive/HER2-negative early breast cancer
    PALbociclib CoLlaborative Adjuvant Study:
    Ensayo de fase III aleatorizado de palbociclib con tratamiento endocrino adyuvante estándar frente a monoterapia con tratamiento endocrino adyuvante estándar en cáncer de mama primario con receptores hormonales positivos/HER2-negativo
    A.3.2Name or abbreviated title of the trial where available
    PALLAS
    PALLAS
    A.4.1Sponsor's protocol code numberAFT-05/ABCSG-42/BIG_14-03
    A.5.4Other Identifiers
    Name:IND numberNumber:126003
    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 SponsorABCSG GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationABCSG
    B.5.2Functional name of contact pointTrial Office (Studienzentrale)
    B.5.3 Address:
    B.5.3.1Street AddressNussdorfer Platz 8
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1190
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314089230
    B.5.5Fax number+4314090990
    B.5.6E-mailinfo@abcsg.at
    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 namePalbociclib
    D.3.2Product code PD-0332991-00
    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.3.9.2Current sponsor codePD-0332991
    D.3.9.3Other descriptive namePD-332,991
    D.3.9.4EV Substance CodeSUB34094
    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 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 namePalbociclib
    D.3.2Product code PD-0332991-00
    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.3.9.2Current sponsor codePD-0332991
    D.3.9.3Other descriptive namePD-332,991
    D.3.9.4EV Substance CodeSUB34094
    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 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 namePalbociclib
    D.3.2Product code PD-0332991-00
    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.3.9.2Current sponsor codePD-0332991
    D.3.9.3Other descriptive namePD-332,991
    D.3.9.4EV Substance CodeSUB34094
    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
    To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
    Determinar si la adición de palbociclib al tratamiento endocrino adyuvante mejorará la evolución con respecto a la monoterapia con tratamiento endocrino en el cáncer de mama primario con RH+ y HER2-negativo.
    E.1.1.1Medical condition in easily understood language
    To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
    Determinar si la adición de palbociclib al TTO endocrino adyuvante mejorará la evolución con respecto a la monoterapia con tratamiento endocrino en el cáncer de mama primario con RH+ y HER2-negativo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive 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 compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC).
    Comparar la supervivencia libre de enfermedad invasiva (SLEi) con la combinación de tratamiento endocrino durante al menos cinco años y tratamiento con palbociclib durante dos años frente a monoterapia con tratamiento endocrino durante al menos cinco años en pacientes con cáncer de mama primario (CMP) invasivo con RH+ y HER2-negativo confirmado histológicamente.
    E.2.2Secondary objectives of the trial
    To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS).

    To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.
    Comparar los criterios de valoración siguientes: SLEi con exclusión de los segundos cánceres primarios de origen no mamario, supervivencia libre de recidiva a distancia (SLRD), supervivencia libre de recidiva locorregional (SLRLR) y supervivencia global (SG).

    Comparar la seguridad de palbociclib durante dos años con tratamiento endocrino adyuvante frente a monoterapia con tratamiento endocrino adyuvante.
    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) Premenopausal and postmenopausal women or men with Stage II (Stage IIA limited to a max. of 1000 patients) or Stage III early invasive breast cancer per AJCC Breast Cancer Staging version 7 /UICC . Baseline staging to document absence of metastatic disease is not required, however is recommended as determined by institutional practice.
    (4) Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-.
    (5) Patients must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer. ER, PR and HER2 measurements should be performed acc. 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 guidelines. Patients with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are eligible, as long as they have not received and are not scheduled to receive anti-HER2 treatment. Testing may occur on diagnostic core or surgical tumor tissue.
    (6) Patients must have undergone breast surgery for the current malignancy.
    (7) A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be transmitted to a central sample repository and confirmation of receipt must be available prior to randomization.
    (8) ECOG performance status 0-1.
    (9) Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.
    (10) 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 treatment Arm A or B 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.

    Prior Treatment Specifics
    (11) Patients may or may not have received neo/adjuvant therapy, but must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects per physician assessment at the time of randomization.
    (12) Patients may or may not have received breast/axilla/post-mastectomy chest wall radiotherapy, but must be after last dose of radiotherapy and must have sufficient resolution of side effects per physician assessment at the time of randomization.
    (13) Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment with no active wound healing complications at the time of randomization.
    (14) Patients must either be initiating or have already started adjuvant hormonal treatment. Patients may already have initiated endocrine therapy at the time of randomization, but randomization must take place within 12 months of date of histological diagnosis and within 6 months of initiating standard adjuvant endocrine therapy. Patients who received neoadjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy. Patients may be receiving either tamoxifen or aromatase inhibitor (AI: letrozole, anastrozole, or exemestane). For premenopausal patients and men, concurrent LHRH agonist use is allowable and may also be ongoing at the time of randomization.

    Baseline Body Function Specifics
    (15) Absolute neutrophil count ? 1,500/mm3
    (16) Platelets ? 100,000/ mm3
    (17) Hemoglobin ? 10g/dL
    (18) Total serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert?s Syndrome.
    (19) Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ? 1.5 × institutional ULN.
    (20) Serum creatinine within normal institutional limits or creatinine clearance ? 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
    1-Obtención del consentimiento informado firmado antes de realizar evaluaciones y procedimientos específicos del estudio.
    2-Edad >= 18 años (o conforme a las normas nacionales).
    3-Mujeres pre/posmenopáusicas o varones con cáncer de mama invasivo primario en estadio II (estadio IIA limitado a un máximo de 1000 pacientes) o III según Clasificación del cáncer de mama del versión 7/UICC. No se exigirá Clasificación basal para confirmar la ausencia de enfermedad metastásica, pero sí se recomendará según la práctica habitual.
    4-Pacientes con cáncer de mama invasivo primario multicéntrico y/o multifocal y/o bilateral cuyos tumores examinados histopatológicamente cumplan todos los criterios anatomopatológicos de RE+ y/o RP+ y HER2-negativo.
    5-Los pacientes deberán presentar un cáncer de mama invasivo primario con receptores hormonales positivos (RE+ o RP+) y HER2-negativo confirmado histológicamente. Las determinaciones de RE, RP y HER2 se realizarán de acuerdo con las normas del centro, en un contexto aprobado por la CLIA en los EE.UU. o en laboratorios certificados en el resto de regiones. Los valores límite para definir tinción positiva/negativa deberán ser conformes con las directrices actuales de la ASCO/CAP. Los pacientes con resultados dudosos de hibridación in situ de HER2 con arreglo a las directrices actuales de la ASCO/CAP podrán participar siempre que no hayan recibido ni tengan previsto recibir TTO anti-HER2. Los análisis podrán efectuarse en tejido tumoral quirúrgico o de biopsia diagnóstica con aguja gruesa.
    6-Los pacientes deberán haberse sometido a cirugía mamaria por la neoplasia maligna presente.
    7-Tendrá que enviarse un bloque de tejido tumoral fijado con formol e incluido en parafina (FFIP) a un banco de muestras central y disponerse de la confirmación de la recepción antes de la aleatorización. En la sección 8.2 del protocolo se facilitan más detalles.
    8-Estado funcional del ECOG de 0-1.
    9-Los pacientes deberán tener disposición y capacidad de tragar y retener medicación oral sin trastornos que puedan interferir en la absorción intestinal.
    10-Prueba de embarazo en suero u orina negativa en los siete días previos a la aleatorización en las mujeres en edad fértil. No será necesario realizar pruebas de embarazo en las pacientes que sean consideradas posmenopáusicas antes de la aleatorización, según lo determinado por la práctica local, o que se hayan sometido a una ooferectomía bilateral, histerectomía total o ligadura de trompas bilateral. Las mujeres en edad fértil y los varones aleatorizados a los grupos de TTO A y B deberán utilizar métodos anticonceptivos adecuados durante el TTO del protocolo y hasta seis meses después del último TTO con palbociclib en caso de quedar incluidos en el grupo A. Se entiende por métodos anticonceptivos adecuados un método muy eficaz (es decir, abstinencia o esterilización femenina o masculina) o dos métodos eficaces (por ejemplo, DIU no hormonal y preservativo/capuchón oclusivo con espuma/gel/película/crema/supositorio espermicida).
    11-Los pacientes podrán haber recibido TTO neo/adyuvante, si bien tendrán que haber recibido ya la última dosis de quimioterapia o TTO biológico y presentar una resolución suficiente de los efectos secundarios según la evaluación del médico en el momento de la aleatorización.
    12-Los pacientes podrán haber recibido radioterapia sobre la mama, axila o pared torácica posmastectomía, si bien tendrán que haber recibido ya la última dosis de radioterapia y presentar una resolución suficiente de los efectos secundarios según la evaluación del médico en el momento de la aleatorización.
    13-Los pacientes deberán presentar una resolución suficiente de los efectos secundarios quirúrgicos de la última intervención quirúrgica según la evaluación del médico, sin complicaciones activas en la cicatrización de las heridas, en el momento de la aleatorización.
    14-Los pacientes deberán estar iniciando o haber comenzado ya un TTO endocrino adyuvante.
    15-Recuento absoluto de neutrófilos >= 1500/mm3.
    16-Plaquetas >= 100.000/mm3.
    17-Hemoglobina >=10 g/dl.
    18-Bilirrubina sérica total <= LSN o bilirrubina total <= 3,0 veces el LSN con bilirrubina directa dentro del intervalo normal en los pacientes con síndrome de Gilbert documentado.
    19-Aspartato aminotransferasa (AST o SGOT) y alanina aminotransferasa (ALT o SGPT) <= 1,5 veces el LSN del laboratorio local.
    20-Creatinina sérica dentro de los límites normales del centro o aclaramiento de creatinina >= 60 ml/min/1,73 m2 en los pacientes con concentraciones de creatinina sérica por encima del LSN del laboratorio local.
    E.4Principal exclusion criteria
    (1) Concurrent therapy with other Investigational Products.
    (2) Prior therapy with any CDK inhibitor.
    (3) Patients with Stage I or IV breast cancer are not eligible. Baseline staging to document absence of metastatic disease is not required, however is recommended as determined by institutional practice.
    (4) History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
    (5) Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization.
    (6) Uncontrolled intercurrent 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.
    (7) 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.
    (8) Patients with a history of any malignancy are ineligible except for the following circumstances:
    ? Patients with a malignancy history other than invasive breast cancer are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
    ? Patients with the following cancers are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic non-melanomatous skin cancer.
    (9) Patients are not eligible if they have previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy. This includes use for prophylactic reasons, including treatment of osteoporosis or cancer prevention with tamoxifen, raloxifene or AI. Patients may concurrently receive bisphosphonates or rank ligand inhibitors while on this study if necessary for treatment or prevention of osteopenia or osteoporosis.
    (10) 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.
    (11) Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis, etc.
    (12) Patients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil, etc.) are not eligible but topical vaginal estrogen therapy is allowable.
    (1) Tratamiento simultáneo con otros productos en investigación.
    (2) Tratamiento previo con cualquier inhibidor de CDK.
    (3) No podrán participar pacientes con cáncer de mama en estadio I o IV. No se exigirá Clasificación basal para confirmar la ausencia de enfermedad metastásica, pero sí se recomendará conforme a lo determinado por la práctica habitual del centro (en los pacientes en que pueda haber una sospecha razonable de enfermedad avanzada, por ejemplo, tumores grandes, ganglios linfáticos axilares clínicamente positivos, signos y síntomas). De llevarse a cabo, los informes de estas pruebas tendrán que encontrarse disponibles. Los tipos de pruebas para fines de Clasificación, es decir, radiografías, ecografía, gammagrafía ósea, TC, RM o PET-TC, quedarán a criterio del investigador.
    (4) Antecedentes de reacciones alérgicas atribuidas a compuestos con una composición química o biológica similar a la de palbociclib.
    (5) Pacientes en tratamiento con fármacos o sustancias que sean inhibidores o inductores potentes de la isoenzima CYP3A en los siete días previos a la aleatorización (véase en la sección 9.5.2.1 del protocolo una lista de inhibidores e inductores de la enzima CYP3A).
    (6) Enfermedad intercurrente no controlada, entre otras, infección en curso o activa, insuficiencia cardíaca congestiva sintomática, angina de pecho inestable, arritmia cardíaca, diabetes o enfermedad psiquiátrica/situaciones sociales, que podría limitar el cumplimiento de los requisitos del estudio. La capacidad de cumplir los requisitos del estudio tendrá que ser evaluada por el investigador en el momento de la selección para participar en el estudio.
    (7) Las mujeres embarazadas, así como las que estén en edad fértil y no tengan una prueba de embarazo (en suero u orina) negativa en los siete días previos a la aleatorización, independientemente del método anticonceptivo utilizado, no podrán participar en este estudio porque se desconocen los efectos de palbociclib sobre el feto en desarrollo. La lactancia deberá interrumpirse antes de incorporarse al estudio.
    (8) No podrán participar pacientes con antecedentes de cualquier neoplasia maligna, excepto en las circunstancias siguientes:
    ? Los pacientes con antecedentes de neoplasias malignas distintas del cáncer de mama invasivo podrán participar siempre que hayan estado libres de enfermedad durante al menos cinco años y el investigador considere que corren un riesgo bajo de presentar recidiva de esa neoplasia maligna.
    ? Podrán participar pacientes con los siguientes cánceres, aun cuando hayan sido diagnosticados y tratados en los últimos cinco años: carcinoma de mama ductal in situ, cáncer de cuello uterino in situ y cáncer de piel distinto del melanoma no metastásico.
    (9) No podrán participar pacientes que hayan recibido tratamiento endocrino en los cinco años previos al diagnóstico de la neoplasia maligna presente. Esto incluye el uso con fines profilácticos, incluido el tratamiento de la osteoporosis o la prevención del cáncer con tamoxifeno, raloxifeno o inhibidor de la aromatasa. Durante el estudio, los pacientes podrán recibir bisfosfonatos o inhibidores del ligando de RANK de forma concomitante, siempre que sea necesario para el tratamiento o la prevención de la osteopenia u osteoporosis.
    (10) No podrán participar pacientes que estén recibiendo tratamiento antirretroviral combinado, por ejemplo los que estén infectados por el VIH, debido a la posibilidad de interacciones farmacocinéticas o incremento de la inmunodepresión con palbociclib.
    (11) Pacientes con antecedentes clínicamente significativos de hepatopatía, como hepatitis vírica o de otro tipo conocida, alcoholismo activo, cirrosis, etc.
    (12) No podrán participar pacientes que estén recibiendo tratamiento concomitante con hormonas exógenas (tratamiento hormonal sustitutivo, anticonceptivos orales u hormonales de otro tipo, como espiral anticonceptiva hormonal, etc.), pero sí será aceptable el tratamiento con estrógenos vaginales tópicos.
    E.5 End points
    E.5.1Primary end point(s)
    Invasive disease-free survival (iDFS) defined acc. to STEEP criteria
    (Supervivencia libre de enfermedad invasiva (SLEi), definida conforme a los criterios STEEP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First interim analysis will take place after first 157 iDFS events have occured (33% of total number of iDFS events; estimated <3 years after FPI) and the second interim analysis after accrual is completed and 313 iDFS events have occured (67% of total iDFS events; estimated <4 years after FPI). The final analysis of iDFS will occur when 469 iDFS events (100%) are observed.
    El primer análisis intermedio se realizará cuando se hayan producido los primeros 157 episodios de SLEi (cuando se observen el 33 % del número total de episodios de SLEi; menos de 3 años después de la aleatorización del primer paciente) y el segundo análisis intermedio, una vez finalizada la inclusión de pacientes y tras haberse producido 313 episodios de SLEi (cuando se observen el 67 % del número total de episodios de SLEi; menos de 4 años después de la aleatorización del primer paciente) . Se calcula que el primer y el segundo análisis intermedios tendrán lugar menos de tres y cuatro años, respectivamente, después de la aleatorización del primer paciente. El análisis final tendrá lugar cuando se observen 469 episodios de SLEi (100%).
    E.5.2Secondary end point(s)
    (1) Invasive disease-free survival (iDFS) excl. second primary cancers of non-breast origin as an event.
    (2) Overall Survival (OS)
    (3) Locoregional recurrences-free survival (LRRFS) defined as the composite of local/regional ipsilateral recurrence, contralateral invasive breast cancer or death from any cause
    (4) Distant recurrence free survival (DRFS) is defined acc. to STEEP criteria as the composite of distant recurrence or death from any cause.
    (5) Adverse Events
    (1) Supervivencia libre de enfermedad invasiva (SLEi) con exclusión de los episodios de segundos cánceres primarios de origen no mamario.
    (2) Supervivencia global (SG).
    (3) Supervivencia libre de recidiva locorregional (SLRLR), definida como la combinación de recidiva locorregional ipsolateral, cáncer de mama invasivo contralateral y muerte por cualquier causa.
    (4) Supervivencia libre de recidiva a distancia (SLRD), definida según los criterios STEEP como la suma de recidiva a distancia y muerte por cualquier causa.
    (5) Acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the first secondary endpoint, first interim analysis will take place after first 157 iDFS events have occured (33% of total number of iDFS events; estimated <3 years after FPI) and the second interim analysis after accrual is completed and 313 iDFS events have occured (67% of total iDFS events; estimated <4 years after FPI). The final analysis of iDFS will occur when 469 iDFS events (100%) are observed. All other secondary endpoints will be analyzed after the occurence of 469 iDFS events.
    Para el primero objetivo segundario, el primer análisis intermedio se realizará cuando se hayan producido los primeros 157 episodios de SLEi (cuando se observen el 33 % del número total de episodios de SLEi; menos de 3 años después de la aleatorización del primer paciente) y el segundo análisis intermedio, una vez finalizada la inclusión de pacientes y tras haberse producido 313 episodios de SLEi (cuando se observen el 67 % del número total de episodios de SLEi; menos de 4 años después de la aleatorización del primer paciente). El análisis final tendrá lugar cuando se observen 469 episodios de SLEi (100%). Todos los otros objectivos segundarios se analizará después que se observen 469 episodios de SLEi.
    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 No
    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) 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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA177
    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
    Austria
    Belgium
    Canada
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    Singapore
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    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
    End of study is the date when the last patient has completed their end of study visit, all data have been collected, and all queries have been resolved.
    La visita de final del estudio de un paciente será su última visita formal del estudio, todos los datos estén recopilados y todas las dudas resueltas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years15
    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: 4600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4600
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state199
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1646
    F.4.2.2In the whole clinical trial 4600
    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)
    standard after care according to institutional guidellines
    Practica Clínica Habitual de acuerdo con las normas de la institución.
    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 Breast International Group (BIG)
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation AFT (Alliance Foundation Trials)
    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 Decision2016-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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