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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-002392-27
    Sponsor's Protocol Code Number:A5481003
    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:2010-10-22
    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 number2008-002392-27
    A.3Full title of the trial
    "Estudio en fase 1/2, abierto y aleatorizado de la seguridad, eficacia y farmacocinética de letrozol más PD 0332991 (inhibidor oral de CDK 4/6) y letrozol en monoterapia, para el tratamiento en primera línea del cáncer de mama avanzado RE-positivo y Her2-negativo en mujeres posmenopáusicas"

    "PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN"
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code numberA5481003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPFIZER
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namePD-0332991
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePD-0332,991
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 namePD-0332991
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePD-0332,991
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 FEMARA 2,5 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMACEUTICA, S.A.
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLETROZOL
    D.3.9.3Other descriptive nameLETROZOLE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    "Cancer de Mama avanzado" "Advanced Breast Cancer"
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Fase 1: España NO participará en esta fase porque ya ha finalizado.

    Fase 2: Valorar el efecto del letrozol combinado con PD 0332991 y del letrozol solo sobre la supervivencia sin progresión (SSP) en el tratamiento de primera línea del CMA RE+ y HER2 negativo en mujeres posmenopáusicas en quienes se haya identificado prospectivamente la presencia de tumores con amplificación de CCND1 y/o ausencia de p16.
    E.2.2Secondary objectives of the trial
    Fase 1: España NO participará en esta fase porque ya ha finalizado.

    Fase 2:
    • SSP de la parte 1
    • RO (Respuesta Tumoral Objetiva)
    • RCB
    • Tiempo hasta la progresión del tumor (TP)
    • Duración de la respuesta (DR)
    • Supervivencia global (SG)
    • Perfil de seguridad global
    • Resultado comunicado por el paciente (RCP) de dolor usando el modified Brief Pain Inventory – short form (mBPI sf)
    • Niveles tisulares tumorales incluidos, entre otros, los de Rb, p16/INK4A, CCND1, CDK4, CDK6 y Ki67, y número de copias de CCND1 y p16
    • Polimorfismo de línea celular en los genes CYP19A1 y CCND1.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Suplemento de Perfil Molecular version de fecha 27 de Marzo de 2008
    E.3Principal inclusion criteria
    Los sujetos deberán cumplir todos los criterios de inclusión siguientes para considerarse elegibles para la inclusión en el estudio:
    1. Diagnóstico comprobado histológica o citológicamente de adenocarcinoma de mama con signos de 1) enfermedad localmente recurrente no adecuada para resección o radioterapia con intención curativa o 2) enfermedad metastática.
    2. Tumor positivo para RE. Se considera positivo un resultado de >ó=10 fmol de unión a H3 estrógeno por mg de proteína citosólica en los métodos del carbón activo recubierto de dextrano y de densidad de sacarosa, o de >ó=0,10 fmol de unión a H3 estrógeno por mg de ADN en la técnica de IF/EIA. Si se utiliza inmunohistoquímica, debe citarse en el informe el estado de receptores positivos de acuerdo con las normas estándar del laboratorio.
    3. Cáncer de mama HER2 negativo por FISH o IHQ.
    4. Disponibilidad de bloques tumorales incluidos en parafina para valoración central de Rb y otras proteínas relacionadas con el ciclo celular. Únicamente en la parte 2 de la fase 2 : Determinación por el laboratorio central de amplificación de CCND1 y/o ausencia de p16.
    5. Enfermedad mensurable según los RECIST o enfermedad sólo ósea (sólo en la fase 2). Las lesiones irradiadas previamente sólo se consideran mensurables si se comprueba progresión en el centro después de completarse la radiación.
    6. Mujeres de edad igual o superior a 18 años.
    7. Posmenopausia, definida por:
    • Ooforectomía quirúrgica bilateral previa
    • Amenorrea y edad >ó= 60 años
    • Edad < 60 años y amenorrea durante 12 o más meses en ausencia de quimioterapia, tamoxifeno, toremifeno o supresión ovárica y FSH y estradiol en intervalos posmenopáusicos
    8. Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 ó 1 (véase el apéndice 1). 9. Resolución de todos los efectos tóxicos agudos de tratamientos o procedimientos quirúrgicos previos hasta un grado <ó=1 de los CTCAE (a excepción de la alopecia u otros efectos tóxicos que no se consideren un riesgo de seguridad para la paciente).
    10. Función orgánica adecuada, definida por los criterios siguientes:
    • Recuento absoluto de neutrófilos (RAN) >ó= 1500/ul
    • Plaquetas >ó= 100.000/ul
    • Valores de aspartato transaminasa (AST) y de alanina transaminasa (ALT) en suero <ó= 3 x límite superior normal (LSN), o de AST y ALT <ó= 5 x LSN si las anomalías hepáticas se deben a un proceso maligno subyacente
    • Bilirrubina sérica total <ó= 1,5 x LSN con independencia de que haya afectación hepática secundaria al tumor. Se permite la inclusión de pacientes con elevación de la bilirrubina indirecta en suero debida a síndrome de Gilbert.
    • Creatinina sérica <ó= 1,5 x LSN
    • QTc <ó= 470 mseg (basándose en el valor medio de los ECG triplicados)
    11. Documento de consentimiento informado firmado y fechado en el que conste que se ha informado al sujeto (o a su representante legal) de todos los aspectos pertinentes del ensayo antes del reclutamiento.
    12. Disposición a cumplir las visitas programadas, el plan de tratamiento, los análisis de laboratorio y otros procedimientos del estudio, y capacidad para hacerlo.
    E.4Principal exclusion criteria
    No se incluirá en el estudio a los sujetos que cumplan cualquiera de las condiciones siguientes:
    1. Metástasis cerebrales (aunque estén tratadas y estables), compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea.
    Cirugía mayor en las 3 semanas previas al primer tratamiento del estudio.
    Tratamiento previo con:
    • Cualquier tratamiento del cáncer para la enfermedad avanzada, a excepción de la radioterapia a < 25 % de la médula ósea al menos dos semanas antes del inicio del tratamiento del estudio (véase el apéndice 2)
    • Letrozol (neo)adyuvante con recurrencia de la enfermedad <ó=12 meses (sólo en la fase 2)
    • Cualquier inhibidor de la CDK
    Tratamiento en curso con:
    • Cualquier tratamiento del cáncer para la enfermedad avanzada
    • Cualquier tratamiento experimental en otro ensayo clínico
    • Dosis terapéuticas de anticoagulantes. Se permite utilizarlos en dosis bajas para profilaxis de la trombosis venosa profunda. Se permite el uso de heparina de bajo peso molecular. Se permite el uso de aspirina.
    Uso actual o necesidad prevista de:
    • alimentos o fármacos que sean inhibidores potentes conocidos de la CYP3A4 (es decir, zumo de pomelo, verapamilo, ketoconazol, miconazol, itraconazol, posaconazol, eritromicina, claritromicina, tilitromicina, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodona, diltiazem y delavirdina), tanto en la fase 1 como en la 2
    • fármacos que sean inductores potentes conocidos de la CYP3A3 (es decir, carbamazepina, dexametasona, felbamato, omeprazol, fenobarbital, fenitoína, primidona, rifabutina, rifampicina, rifapentina, clevidipina e hipérico), sólo en la fase 1.
    Diagnóstico de un proceso maligno secundario en los 3 últimos años, a excepción del cáncer de piel basocelular o escamocelular debidamente tratado, o carcinoma in situ del cuello uterino
    Cualquiera de los siguientes eventos en los 6 meses previos: infarto de miocardio, angina grave o inestable, disritmias cardíacas en curso de grado >ó= 2 de los CTCAE del NCI, fibrilación auricular de cualquier grado, injerto de derivación de arteria coronaria o periférica, insuficiencia cardíaca congestiva sintomática, accidente cerebrovascular incluido ataque isquémico transitorio o embolia pulmonar sintomática.
    Enfermedad intestinal inflamatoria activa o diarrea crónica. Síndrome del intestino corto. Cirugía del aparato digestivo superior, incluida resección gástrica.
    Hipersensibilidad conocida al letrozol o a cualquier de sus excipientes
    Infección conocida por el virus de la inmunodeficiencia humana
    Otro proceso médico o psiquiátrico grave, agudo o crónico u otra anomalía analítica que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o pueda interferir en la interpretación de los resultados del estudio y que, a juicio del investigador, haría inadecuada la inclusión del sujeto en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Fase 1: España NO participará en la Fase 1 por haber finalizado.

    Fase 2: Supervivencia sin progresión (SSP) de la parte 2
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Yes
    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 No
    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 EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Segun el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    El consentimiento puede ser dado por el representante legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 150
    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 Decision2010-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-20
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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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