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    Summary
    EudraCT Number:2010-024099-25
    Sponsor's Protocol Code Number:MO22982
    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:2011-07-29
    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 number2010-024099-25
    A.3Full title of the trial
    A randomized, multi-center cross-over study to evaluate patient preference and Health Care Professional (HCP) satisfaction with subcutaneous (SC) administration of trastuzumab in HER2-positive early breast cancer (EBC)
    Estudio multicéntrico, randomizado, cruzado, para evaluar la preferencia de las pacientes y la satisfacción de los profesionales sanitarios (PS) con la administración subcutánea (SC) de trastuzumab en cáncer de mama precoz (CMP) HER2-positivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate both patients' preference and doctors' and nurses' satisfaction with subcutaneous administration(under the skin) of trastuzumab in patients with breast cancer.

    Estudio para evaluar la preferencia y satisfacción de pacientes, médicos y enfermeras con la administración subcutanea (balo la piel) de trastuzuman en pacientes con cáncer de mama
    A.3.2Name or abbreviated title of the trial where available
    PrefHer Study
    A.4.1Sponsor's protocol code numberMO22982
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 12
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4050
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41616881111NA
    B.5.5Fax number+41616919319NA
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHerceptin SC
    D.3.2Product code Ro 045-2317/F06
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrastuzumab SC
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 nameHerceptin SC
    D.3.2Product code Ro 045-2317/F04
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrastuzumab sc
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Herceptin®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Cáncer de mama precoz HER2 positivo
    E.1.1.1Medical condition in easily understood language
    Cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la proporción de pacientes que indican una preferencia global por la vía de administración subcutánea (SC) o intravenosa (IV).
    E.2.2Secondary objectives of the trial
    - Satisfacción de los profesionales sanitarios con trastuzumab SC
    - Ahorro de tiempo percibido por los profesionales sanitarios con trastuzumab SC
    Seguridad y tolerancia
    - Eficacia – supervivencia libre de acontecimientos (SLA)
    - Inmunogenicidad de trastuzumab e hialuronidasa recombinante humana (rHuPH20)

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio de tiempo y movimiento de las formulaciones subcutánea (SC) e intravenosa (IV) de trastuzumab para el tratamiento de pacientes con cáncer de mama precoz (CMP) positivo para HER2. 28 de junio de 2011 Versión 5.0.
    Objetivos principales:
    -Cuantificar la utilización de recursos en cuanto al tiempo “activo” de los PS y en cuanto a los consumibles así como sus costes asociados relacionados con la inyección SC de trastuzumab (con dispositivo de inyección de un solo uso [DIS]) y la infusión IV de trastuzumab en el tratamiento de pacientes con CMP positivo para HER2 en el contexto del ensayo clínico PrefHer.
    -Calcular el tiempo medio y los costes de los procesos SC e IV por paciente y por centro así como el ahorro potencial estimado de tiempo y costes por centro y por país (agrupando los datos de todos los centros de un país) derivado del cambio de la vía de administración IV a SC.
    Objetivo secundario:
    -Calcular el tiempo que permanece la paciente en la unidad asistencial y el tiempo en sillón para trastuzumab SC y trastuzumab IV por país.
    Más detalles en protocolo independiente.
    E.3Principal inclusion criteria
    1.Mujeres de ≥ 18 años
    2.Cáncer de mama HER2 positivo
    3.Las pacientes no deben presentar indicios de enfermedad residual, localmente recurrente o metastásica tras completar el tratamiento con cirugía y quimioterapia (en el entorno neoadyuvante o adyuvante).
    4.Las pacientes deben haber completado todo el tratamiento con quimioterapia (neo)adyuvante, pero podrán ser incluidas en el estudio mientras estén recibiendo radioterapia adyuvante.
    5.Las pacientes pueden haber recibido previamente trastuzumab IV, sin embargo, la paciente debe estar pendiente de recibir, como mínimo, 10 de los 18 ciclos planeados de tratamiento con trastuzumab administrado cada 3 semanas.
    6.Estado funcional ECOG 0 o 1
    E.4Principal exclusion criteria
    1.Antecedentes de otras neoplasias que podrían afectar al cumplimiento con el protocolo o la interpretación de los resultados. Las pacientes con carcinoma in situ de cervix o carcinoma basocelular tratados de forma curativa y las pacientes con otras neoplasias tratadas de forma curativa que hayan estado libres de enfermedad durante al menos 5 años, son aptas para participar en el estudio. Las pacientes con antecedentes de carcinoma ductal in situ (CDIS) de la mama también son aptas para participar en el estudio.
    2.Función de médula ósea inadecuada:
    3.Alteraciones de la función hepática
    4.Función renal inadecuada
    5.enfermedades cardiacas o patologías vasculares graves
    6.Infección confirmada por virus de inmunodeficiencia humana (VIH), hepatitis B activa (VHB) o hepatitis C (VHC)
    7.Administración previa de una dosis acumulada máxima de doxorubicina >360 mg/m2 o de epirubicina >720 mg/m2 o equivalentes
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be assessed by the following question on the second patient interview (PINT2) : ?All things considered which method of administration did you prefer??
    La variable principal se evaluará mediante la siguiente pregunta en la segunda entrevista con la paciente (PINT2): “Teniendo en cuenta todos los aspectos, ¿qué método de administración prefería usted?”.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Una vez que las pacientes hayan completado los 8 primeros ciclos del tratamiento del estudio, es decir, 4 ciclos de trastuzumab SC y 4 ciclos de trastuzumab i.v.
    E.5.2Secondary end point(s)
    •Satisfacción de los profesionales sanitarios con trastuzumab SC
    •Ahorro de tiempo percibido por los profesionales sanitarios con trastuzumab SC
    •Seguridad
    •Eficacia
    •Inmunogenicidad de trastuzumab e hialuronidasa recombinante humana (rHuPH20)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ver protocolo MO22982, sección 8.2.1.2 Variables secundarias
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity; Patient preference; HCP Satisfaction
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Denmark
    France
    Germany
    Italy
    Poland
    Russian Federation
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    El estudio terminará con la última visita realizada por la última paciente (UVUP) en el período de seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 200
    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)
    Las pacientes que finalicen su participación en el estudio, serán tratadas con la práctica clínica local. Las pacientes que discontinúen el tratamiento serán evaluadas por el investigador. Si en el momento de la retirada del estudio de la paciente hay un acontecimiento adverso (AA), se debe realizar su seguimiento hasta que se observe la resolución o una estabilización, o hasta perdida de seguimiento de la paciente, o se determine que la causa no es la participación o tratamiento del estudio.
    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 Decision2011-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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