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    Summary
    EudraCT Number:2011-004476-10
    Sponsor's Protocol Code Number:GEICAM/2011-02
    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:2011-11-22
    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 number2011-004476-10
    A.3Full title of the trial
    Phase II, open-label, non-randomized study of nab-paclitaxel for the neoadjuvant treatment of patients with stage II and III luminal breast cancer.
    Estudio Fase II, abierto, no randomizado con nab-paclitaxel para el tratamiento neoadyuvante de pacientes con cáncer de mama luminal estadios II y III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, open-label, non-randomized study of nab-paclitaxel for the neoadjuvant treatment of patients with stage II and III luminal breast cancer.
    Estudio Fase II, abierto, no randomizado con nab-paclitaxel para el tratamiento neoadyuvante de pacientes con cáncer de mama luminal estadios II y III.
    A.4.1Sponsor's protocol code numberGEICAM/2011-02
    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 SponsorFundación Grupo Español de Investigación en Cáncer de Mama (Fundación GEICAM)
    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 supportFundación GEICAM
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Grupo Español de Investigación en Cáncer de Mama (Fundación GEICAM)
    B.5.2Functional name of contact pointCesar Rodríguez Martín
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Pirinos, 7, 1-14
    B.5.3.2Town/ citySan Sebastian de los Reyes
    B.5.3.3Post code28703
    B.5.3.4CountrySpain
    B.5.4Telephone number+34916592870-
    B.5.5Fax number+34916510406-
    B.5.6E-mailcrmartin@geicam.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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 Powder 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 number150
    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
    Neoadjuvant tratment of patients with stage II - III luminal brest cancer
    Tratamiento neoadyuvante de pacientes con cáncer de mama luminal en estadios II - III
    E.1.1.1Medical condition in easily understood language
    Neoadjuvant tratment of patients with stage II - III luminal brest cancer
    Tratamiento neoadyuvante de pacientes con cáncer de mama luminal en estadios II - III
    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 PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    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 determine the percentage of patients with poor response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.
    Determinar el porcentaje de pacientes con mala respuesta [tasa de carga tumoral residual III (CTR-III)] medida según los criterios de Symmans [20] en la cirugía, en pacientes con cáncer de mama luminal con estadios II-III en tratamiento neoadyuvante con nab-paclitaxel.
    E.2.2Secondary objectives of the trial
    -To determine the pathologic complete response (pCR; RCB-0) rate.
    - To determine de OOR according to RECIST 1.1 measured by MRI and mammogram.
    - To determine the invasive disease free survival.
    - To determine the toxicity of this regimen following the NCI CTCAE v 4.03.
    - To determine de rate of conversion to breast conserving surgery.
    - To correlate Ki67, gp-60, caveolin-1, SPARC, andother candidate predictive
    markers of nab-paclitaxel response with efficacy in pre-treatment tumor samples.
    - To correlate genomic intrinsic subtypes, Luminal and Proliferation meta-genes
    and single genes determined by PAM50 bioassay, with response.
    - To determine biomarkers of resistance to nab-paclitaxel in this population
    - To analyze polymorphisms in genes from pathways that may influence cellular
    sensitivity to nab-paclitaxel
    •Determinar la tasa de respuesta completa patológica (RCp; CTR-0)
    •Determinar de la tasa de respuestas objetivas (TRO) según los RECIST 1.1 [46] determinada mediante RM y mamografía.
    •Determinar la supervivencia libre de enfermedad infiltrante (SLEI).
    •Determinar la toxicidad de este régimen según los CTCAE del NCI v 4.03 [47].
    •Determinar la tasa de conversión a cirugía conservadora de la mama (CCM)
    •Correlacionar Ki67, gp-60, caveolina-1, SPARC y otros marcadores predictivos de la respuesta de nab-paclitaxel con la eficacia en muestras tumorales previas al tratamiento.
    •Correlacionar los subtipos genómicos intrínsecos, genes y metagenes luminal y de proliferación determinados por el bioensayo PAM50, con la eficacia.
    •Determinar los biomarcadores de resistencia a nab-paclitaxel en esta población.
    •Analizar los polimorfismos en genes de vías que pueden influir en la sensibilidad celular a nab-paclitaxel


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients with histologically confirmed diagnosis of primary unilateral
    invasive early breast cancer with longest tumor size in breast 2cm, or < 2 cm with
    axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be 2cm (unless axillary involvement) and is
    designated as the ?target? lesion for all subsequent tumor evaluations.
    2. The breast tumors must be ER positive: more than 1% of stained tumor cells by IHC, and HER2 negative: 0, or 1+ score by IHC, or 2+ with FISH/CISH negative for
    HER2 amplification (defined as a ratio of HER-2/neu copies to chromosome 17
    centromere (CEP17) signals <1.8), according to the local laboratory).
    3. Are clear candidates to receive chemotherapy by the investigator criteria.
    4. Are at least 18 years of age.
    5. Have at least one unidimensionally measurable lesion by RECIST version 1.1,
    measured by mammogram.
    6. Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2
    7. Have adequate renal and liver function and bone marrow reserve as follows:
    ? Bone marrow: ANC ³ 1.500/mm3 (1.5 x 109/L); platelet count ³ 100.000/mm3
    (100.0 x 109/L); and hemoglobin ³ 9 g/dL.
    ? Hepatic: bilirubin £1.5 times the upper limit of normal (x ULN); alkaline
    phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase
    (ALT) £2.5 × ULN and Albumin 2.5 g/dL.
    ? Renal: serum creatinine <1.5 x ULN.
    8. Exhibit patient compliance and geographic proximity that allow for adequate followup
    9. Entry informed consent form signed by the patient.
    1.Mujeres con diagnóstico confirmado histológicamente de cáncer de mama infiltrante, unilateral, primario y en estadio precoz, en las que el diámetro mayor del tumor en la mama sea ≥ 2 cm, o bien < 2 cm con afectación axilar. En el caso de un tumor multifocal (focos tumorales localizados en el mismo cuadrante), la lesión mayor deberá medir ≥ 2 cm y se designará como lesión “diana” para todas las evaluaciones tumorales posteriores.
    2.El tumor de mama debe tener RE positivos: tinción de más del 1 % de células tumorales mediante IHQ, y HER2 negativo: puntuación 0 o 1+ mediante IHQ, o 2+ con FISH/CISH negativa para amplificación de HER2 (definida como un cociente entre las copias de HER-2/neu y las copias de centrómeros en el cromosoma 17 (CEP17) <1,8), según la evaluación del laboratorio local).
    3.Candidatas claras a recibir quimioterapia según el criterio del investigador.
    4.Edad igual o superior a 18 años.
    5.Presencia de al menos una lesión medible en una dimensión según la versión 1.1 de los criterios RECIST [65], determinada por mamografía.
    6.Estado funcional adecuado: Eastern Cooperative Oncology Group (ECOG) < 2
    7.Función renal y hepática y reserva de la médula ósea adecuadas, conforme a lo siguiente.
    •Médula ósea: RAN ≥ 1.500/mm3 (1,5 x 109/l); plaquetas ≥ 100.000/mm3 (100,0 x 109/l); y hemoglobina ≥ 9,0 g/dl.
    •Función hepática: bilirrubina ≤ 1,5 x límite superior de la normalidad (LSN); fosfatasa alcalina (FA), aspartato transaminasa (AST) y alanina aminotransferasa (ALT) ≤ 2,5 × LSN y albúmina ≥ 2,5 g/dl.
    •Función renal: creatinina sérica <1.5 x ULN.
    8.Cumplimiento terapéutico de la paciente y proximidad geográfica que permita un seguimiento adecuado.
    9.Documento de consentimiento informado para la entrada en el ensayo también firmado por la paciente.
    E.4Principal exclusion criteria
    1. Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
    2. Synchronous contralateral or multicentric breast cancer.
    3. Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis.
    4. Second primary malignancy, except adequately treated carcinoma in situ of the
    cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell
    carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and
    lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was
    diagnosed and definitively treated more than 5 years ago with no subsequent
    evidence of recurrence.
    5. Prior or concurrent anti-cancer therapy for current disease (hormone therapy,
    chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
    6. Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.
    7. Patients with known hypersensitivity to nab-paclitaxel or any of its components.
    8. Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria
    9. Have received treatment within the last 4 weeks with a drug that has not
    received regulatory approval for any indication at the time of study entry.
    10. Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
    11. Patient is pregnant or breast feeding or planning to become pregnant within
    the six months after the end of treatment. Women with child-bearing potential
    must be performed a pregnancy serum or urine testing within 7 days prior to
    study entry according to institutional standards and should use an adequate
    non-hormonal contraceptive method (intra-uterine contraceptive device,
    barrier method of contraception in conjunction with spermicidal jelly or
    surgically sterilized) during treatment with study drugs and within the six
    months after the end of treatment.
    1.Cáncer de mama inflamatorio (T4d) o ganglios linfáticos supraclaviculares (N3)
    2.Cáncer de mama multicéntrico o contralateral sincrónico.
    3.Indicios clínicos o radiológicos de enfermedad metastásica. En caso de sospecha de metástasis, se realizará antes del reclutamiento una exploración torácica mediante radiografía o TC, una exploración abdominal mediante ecografía o TC, una exploración ósea mediante gammagrafía ósea y otros métodos radiológicos para descartar las metástasis.
    4.Segundo tumor maligno primario, excepto carcinoma in situ del cuello uterino, cáncer de colon en estadio I, melanoma no infiltrante y carcinoma basocelular o espinocelular de piel, carcinoma ductal in situ (CDIS) ipsilateral de la mama y carcinoma lobulillar in situ (CLIS) de la mama adecuadamente tratados, a menos que la neoplasia maligna previa fuera diagnosticada y tratada de forma definitiva al menos 5 años antes sin indicios posteriores de recidiva.
    5.Tratamiento antineoplásico previo o concomitante para la enfermedad actual (hormonoterapia, quimioterapia, radioterapia, inmunoterapia, terapia biológica, aparte de los tratamientos del ensayo).
    6.Administración concomitante de cualquier tratamiento hormonal, ya sea para la osteoporosis o como tratamiento de sustitución.
    7.Hipersensibilidad conocida a nab-paclitaxel o a alguno de sus componentes.
    8.Neuropatía previa de grado >1 según los criterios NCI-CTCAE v. 4.03
    9.Tratamiento en las 4 semanas anteriores con un fármaco que no esté aprobado por las autoridades sanitarias para ninguna indicación en el momento de la inclusión en el estudio.
    10.Presencia de cualquier enfermedad sistémica concomitante grave que sea incompatible con el estudio (a criterio del investigador).
    11.La paciente está embarazada o en período de lactancia o tiene previsto quedarse embarazada en los seis meses siguientes al final del tratamiento. Las mujeres en edad fértil deben someterse a una prueba de embarazo en suero u orina en los 7 días previos a la inclusión según las normas institucionales y utilizar un método anticonceptivo no hormonal adecuado (dispositivo intrauterino, método de barrera en conjunción con crema espermicida o esterilización quirúrgica) durante el tratamiento con los fármacos del estudio y en los seis meses siguientes al final del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the study is the residual cancer burden grade III (RCB-III).
    La variable principal de este estudio es la carga tumoral residual III (CTR-III)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will take place after the last enrolled patient has received surgery.
    El análisis primario se llevará a cabo después de que al último paciente registrado se le haya realizado la cirugía
    E.5.2Secondary end point(s)
    - Analysis for pathological Response Rate
    - Analysis for objective response
    - Analysis for vascular response
    - Analysis for rate of conversion to BCS
    - Time-to-event Analyses
    -Analisis de la tasa de respuesta patológica
    -Analisis de la prespuesta objetiva
    -Analisis de la respuesta vascular
    -Análisis de la tasa de conversión de CCM
    -Análisis del tiempo transcurrido hasta el evento
    E.5.2.1Timepoint(s) of evaluation of this end point
    After surgery
    Después de cirugía
    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 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 No
    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 trial1
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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 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
    This study will be considered complete following the data cut-off date and datalock for
    the final analysis. The data cut-off date for the final analysis will occur after all enrolled
    patients have been followed for at least 5 years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state78
    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)
    As per clinical practice
    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 Decision2012-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-16
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