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    Summary
    EudraCT Number:2013-001036-22
    Sponsor's Protocol Code Number:SOLTI-1114
    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:2013-07-12
    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 number2013-001036-22
    A.3Full title of the trial
    PAM50 HER2-enriched phenotype as a predictor of early response to neoadjuvant lapatinib plus trastuzumab in Stage I to IIIA HER2-positive breast cancer
    Fenotipo HER2-enriquecido determinado por la plataforma PAM50 como predictor de respuesta temprana a la administración neoadyuvante de la combinación de lapatinib y trastuzumab con o sin terapia hormonal en cáncer de mama HER2+ estadios I a IIIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assesment of response predictor genes in patients with initial breast cancer HER2+ to the lapatinib and trastuzumab treatment combination before surgery.
    Determinación de genes predictores de respuesta a la combinación del tratamiento con lapatinib y trastuzumab en pacientes con cancer de mama inicial HER2+ previo a la cirugia.
    A.3.2Name or abbreviated title of the trial where available
    PAMELA
    A.4.1Sponsor's protocol code numberSOLTI-1114
    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 SponsorSOLTI
    B.1.3.4CountrySpain
    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 supportGSK
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOLTI
    B.5.2Functional name of contact pointOficina Operaciones
    B.5.3 Address:
    B.5.3.1Street AddressC/DIPUTACION 256 - 4-1
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08007
    B.5.3.4CountrySpain
    B.5.4Telephone number34933436302
    B.5.5Fax number34932702383
    B.5.6E-mailmorales.pepi@gruposolti.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 Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd.
    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 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 INNLapatinib
    D.3.9.3Other descriptive nameLAPATINIB
    D.3.9.4EV Substance CodeSUB32479
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Letrozol (GENERICO)
    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 nameLetrozol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    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) 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 Citrato de Tamoxifeno (GENERICO)
    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 nameCitrato de Tamoxifeno
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTamoxifen Citrate
    D.3.9.3Other descriptive nameTAMOXIFEN CITRATE
    D.3.9.4EV Substance CodeSUB04672MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 4
    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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    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 nameTrastuzumab
    D.3.4Pharmaceutical form 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.3.9.4EV Substance CodeSUB12612MIG
    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 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: 5
    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 Paclitaxel (genérico)
    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 namePACLITAXEL
    D.3.4Pharmaceutical form 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Untreated invasive breast carcinoma eligible for primary definitive surgery (Stage I-IIIA)
    Carcinoma de mama invasivo, inicial, y apto para la cirugía definitiva (Fase I-IIIA)
    E.1.1.1Medical condition in easily understood language
    Early stage HER2+ breast cancer
    Cancer de mama HER2+ estadio inicial
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the ability of the PAM50 HER2-enriched (HER2-E) subtype to predict pathological complete response in the breast (pCRB) to dual HER2 blockade with lapatinib and trastuzumab, with or without endocrine therapy, at the time of surgery.
    Evaluar la capacidad del subtipo HER2-E determinado con la plataforma PAM50 para predecir la respuesta patológica completa a nivel de la mama (RpCM) en el momento de la cirugía, tras el bloqueo dual del HER2 con lapatinib y trastuzumab (+/- terapia hormonal).
    E.2.2Secondary objectives of the trial
    -To evaluate the ability of the PAM50 HER2-E to predict pCR in the breast and axilla to dual HER2 blockade with lapatinib and trastuzumab, +/- endocrine therapy (ET), at the time of surgery.
    -To evaluate the ability of the PAM50 HER2-E to predict residual cancer burden in the breast to dual HER2 blockade with lapatinib and trastuzumab, +/- ET, at the time of surgery.
    -To evaluate if the hormone receptor (HR)?positive, PAM50 non-Luminal A/B (combined) subtypes benefit from dual HER2 blockade + ET, as measured by the changes in the % of Ki67-positive cells from Day 0 to Day 14 of treatment.
    -To identify gene expression changes from Day 0 to Day 14 after dual HER2 blockade.
    -To evaluate if the correlation to the PAM50 HER2-E centroid, as a continuous variable, predicts pCR and/or RCB in the breast to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery.
    -Evaluar la capacidad del subtipo HER2-E determinado mediante PAM50 para predecir la RpCMA en el momento de la cirugía, tras el bloqueo dual del HER2 con lapatinib y trastuzumab (+/- terapia hormonal).
    -Evaluar la capacidad del subtipo HER2-E determinado mediante PAM50 para predecir la carga tumoral residual (CTR, 0-I vs. II-III) en el momento de la cirugía, tras el bloqueo dual del HER2 con lapatinib y trastuzumab (+/- terapia hormonal).
    -Evaluar si los subtipos no-Luminal A/B según PAM50/HR+ (combinados) se benefician del bloqueo dual del HER2 más terapia hormonal, de acuerdo con los cambios en el porcentaje de células positivas para Ki67 entre el día 0 y el día 14.
    -Identificar los cambios en la expresión génica entre el día 0 y el día 14 tras el bloqueo dual del HER2.
    -Evaluar si la correlación con el centroide del HER2-E según PAM50 (como variable continua) predice la RpCM y/o la CTR atribuibles al bloqueo dual del HER2 con lapatinib y trastuzumab, en el momento de la cirugía.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures
    -Untreated invasive breast carcinoma eligible for primary definitive surgery (stage I-IIIA)
    -Histologically confirmed invasive breast carcinoma, with all of the following characteristics:
    a.Primary tumor >=1cm in largest diameter
    b.cN0-2
    c.No evidence of distant metastasis (M0)
    -HER2-positive invasive breast cancer, centrally determined and defined by CAP guidelines as:
    * 3+ overexpression by IHC (uniform, intense membrane staining of >30% of invasive tumor cells)
    or
    * 2+ or 3+ (in 30% or less neoplastic cells) overexpression by IHC and HER2 gene amplification by in situ hybridization (ISH >6 HER2 gene copies per nucleus, or a ISH ratio [HER2 gene copies to chromosome 17 signals] of >2.2)
    -Female patients
    -Age >=18 years
    -ECOG Performance Status of 0 or 1
    -Adequate organ function defined as:
    *Absolute neutrophil count (ANC) >=1.5 x 109/L
    *Hemoglobin (Hgb) >=10 g/dL
    *Platelets >100 000 /mm3
    *Creatinine <=1.6 mg/dL
    *ALT and AST <=2.5 x ULN
    *Alkaline phosphatase ?5 ULN
    *Total bilirubin <=1.5 mg/dL
    -Baseline LVEF ?50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan
    -Negative ?-HCG pregnancy test (serum) for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after the menopause. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from 2 weeks before administration of the first dose of investigational product until 28 days after the last dose of investigational product
    -Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    1.Consentimiento informado por escrito para todos los procedimientos del estudio, de acuerdo con los requerimientos legales locales, antes de iniciar cualquier procedimiento específico del protocolo
    2.Carcinoma de mama invasivo no tratado, elegible para cirugía definitiva primaria (estadios I-IIIa)
    3.Carcinoma de mama invasivo confirmado histológicamente, con todas las características siguientes:
    a.Tumor primario ?1cm en su diámetro mayor
    b.cN0-2
    c.Sin evidencias de metástasis a distancia (M0)
    4.CM invasivo HER2+, definido por las guías del CAP como:
    a.sobreexpresión 3+ por IHQ (tinción uniforme e intensa de la membrana de >30% de las células tumorales invasivas)
    o
    b.sobreexpresión 2+ o 3+ (en un 30% o menos de las células neoplásicas) por IHQ y amplificación génica de HER2 por hibridación in situ (ISH; >6 copias del gen HER2 por núcleo, o un cociente entre las pruebas de ISH [copias del gen HER2 respecto a señales en el cromosoma 17] >2,2)
    5.Pacientes mujeres
    6.Edad ?18 años
    7.Estado funcional del ECOG de 0 ó 1
    8.Función orgánica adecuada, definida por:
    a.Recuento absoluto de neutrófilos (RAN) ?1,5 x 109/l
    b.Hemoglobina (Hg) ?10 g/dl
    c.Plaquetas >100.000/mm3
    d.Creatinina ?1,6 mg/dl
    e.ALT y AST ?2,5 x LSN,
    f.Fosfatasa alcalina ?5 LSN
    g.Bilirrubina total ?1,5 mg/dl
    9.Fracción de eyección del ventrículo izquierdo (FEVI) basal ?50%, determinada mediante ecocardiograma (ECO) o ventriculografía isotópica (MUGA).
    10.En las mujeres premenopáusicas con capacidad reproductiva (biológicamente fértiles) y en aquellas cuya menopausia se haya producido con una anterioridad menor a 12 meses: prueba de embarazo de ?-HCG (en suero) negativa. Todas las pacientes biológicamente fértiles deberán estar de acuerdo en utilizar un método anticonceptivo fiable y comprometerse a emplearlo desde las 2 semanas previas a la administración de la primera dosis del producto en investigación hasta 28 días después de haber recibido la última dosis del mismo.
    11.Ausencia de anomalías psicológicas, familiares, sociológicas o geográficas que potencialmente puedan dificultar el cumplimiento del protocolo del estudio y la pauta de seguimiento. Estas anomalías deberán ser discutidas con la paciente antes de su inclusión en el estudio.
    E.4Principal exclusion criteria
    -Stage III inoperable breast cancer (e.g. T4 tumors and/or N3)
    -Patients with locally advanced disease, or patients for whom upfront chemotherapy including taxanes and anthracyclines is clinically judged appropriate as optimal neoadjuvant treatment
    -Prior chemotherapy, radiotherapy, or surgery for invasive breast cancer, other than excision of tumor in the contralateral breast, and provided that the patient did not previously receive adjuvant radiotherapy or chemotherapy
    -Subjects with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Subjects with other non-mammary malignancies must have been disease-free for at least 5 years
    -Known or suspected hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances
    -Concurrent congestive heart failure or LVEF <50%
    -Clinically significant (i.e. active) cardiovascular disease, including cerebrovascular accident (<6 months before enrollment), unstable angina pectoris, myocardial infarction ?6 months before enrollment, uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) or high-risk uncontrolled arrhythmias
    -Uncontrolled diabetes mellitus, active peptic ulcer disease, or uncontrolled epilepsy
    -Active uncontrolled infection at the time of enrollment
    -History of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent
    -Use of any investigational agent or participation in another therapeutic clinical trial concurrently or in the previous 30 days before the enrollment
    -Patients who are pregnant or breast-feeding
    -Women of child bearing potential who are unable or unwilling to use contraceptive measures
    -Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee
    -Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
    -Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy other than the trial therapies)
    -Concomitant use of CYP3A4 inhibitors or inducers
    1.Cáncer de mama inoperable en estadio III (p.ej., tumores T4 y/o N3)
    2.Pacientes con enfermedad localmente avanzada, o aquellas en quienes se considere apropiada la quimioterapia de primera línea con taxanos y antraciclinas como tratamiento neoadyuvante óptimo
    3.Quimioterapia, radioterapia o cirugía previas para el cáncer de mama invasivo, a excepción de la resección de tumor en la mama contralateral y a condición de que la paciente no haya recibido previamente radio o quimioterapia adyuvantes
    4.Pacientes con una segunda neoplasia activa simultánea, a excepción del cáncer de piel distinto del melanoma tratado satisfactoriamente, del melanoma in situ o del carcinoma in situ de cérvix. Las pacientes con otras neoplasias malignas no mamarias deberán haber permanecido sin enfermedad durante 5 años como mínimo
    5.Presencia o sospecha de reacción de hipersensibilidad a cualquier fármaco en investigación o compuesto terapéutico, o a sus excipientes
    6.Insuficiencia cardiaca congestiva concomitante o FEVI <50%
    7.Enfermedades cardiovasculares clínicamente significativas (es decir, activas): accidente vascular cerebral (<6 meses previamente a la inclusión), angina inestable, infarto de miocardio ?6 meses antes de la inclusión, hipertensión no controlada (presión sistólica >150 mmHg y/o diastólica >100 mmHg) y arritmias de alto riesgo no controladas
    8.Diabetes mellitus no controlada, úlcera péptica activa o epilepsia no controlada
    9.Infecciones activas no controladas presentes en el momento de la inclusión
    10.Antecedentes de comorbilidades significativas que, a juicio del investigador, puedan interferir con la ejecución del estudio, la evaluación de la respuesta o el consentimiento informado
    11.Uso de cualquier fármaco en investigación o participación en otro ensayo clínico terapéutico de forma simultánea o durante los 30 días anteriores a la inclusión
    12.Pacientes gestantes o en período de lactancia
    13.Mujeres con capacidad de concebir que no puedan o no deseen emplear métodos anticonceptivos
    14.Incapacidad o rechazo a cumplir con el protocolo del estudio o a colaborar plenamente con el investigador o el profesional que él designe
    15.Síndrome de malabsorción, patologías que afecten de forma significativa a la función gastrointestinal o resección gástrica o del intestino delgado. Las pacientes con colitis ulcerosa también quedarán excluidas del estudio
    16.Tratamiento antineoplásico neoadyuvante simultáneo (quimioterapia, radioterapia, inmunoterapia o terapias biológicas, exceptuando los tratamientos del ensayo)
    17.Tratamiento simultáneo con inhibidores o inductores del CYP3A4
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between the PAM50 HER2-enriched versus non HER2-enriched cases to achieve pCRB from dual HER2 blockade with lapatinib and trastuzumab at the time of surgery.
    Comparación entre los casos de PAM50 HER2-enriquecido y PAM50 HER2-no enriquecido para evaluar pCR en la mama tras el bloqueo dual HER2 con lapatinib y trastuzumab en el momento de la cirugia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the surgery
    Despues de la cirugia
    E.5.2Secondary end point(s)
    -Comparison between the PAM50 HER2-enriched versus non HER2-enriched cases to achieve pCR in the breast and axilla from dual HER2 blockade with lapatinib and trastuzumab at the time of surgery.
    Comparación entre los casos de PAM50 HER2-enriquecido y PAM50 HER2-no enriquecido para evaluar pCR en la mama y la axila tras el bloqueo dual HER2 con lapatinib y trastuzumab en el momento de la cirugia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the surgery
    Despues de la cirugia
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Placlitaxel será administrado a las pacientes tras la progresión confirmada por US en la semana 7.
    Paclitaxel will be administered to all patients who have confirmed progression by US at week 7.
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last Visit Last Patient
    Ultima Visita Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 0
    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)
    Following surgery, patients will be treated as per local standards of care at the discretion of the investigator.
    Tras la cirugia los pacientes serán tratados por practica clinica local, a criterio del investigador.
    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 Decision2013-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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