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    Summary
    EudraCT Number:2017-002505-35
    Sponsor's Protocol Code Number:ABCSG_50
    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:2019-12-02
    Trial 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 number2017-002505-35
    A.3Full title of the trial
    BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation
    BRCA-P: un estudio internacional de Fase 3 randomizado, doble ciego, controlado con placebo y multicéntrico para determinar el efecto preventivo del Denosumab sobre el cáncer de mama en mujeres con una mutación germinal en BRCA1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BRCA-P: A Cancer Prevention study to determine if Denosumab can prevent Breast Cancer Development in Women carrying a BRCA1 Germline Mutation
    BRCA-P: un estudio sobre la prevención del cancer para determinar si el Denosumab puede prevenir el desarrollo del cáncer de mama en mujeres que tienen una mutación en el gen BRCA1
    A.3.2Name or abbreviated title of the trial where available
    BRCA-P
    BRCA-P
    A.4.1Sponsor's protocol code numberABCSG_50
    A.5.4Other Identifiers
    Name:AmgenNumber:20157239
    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 SponsorInstitut Català d'Oncologia (ICO)
    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 supportAmgen
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportABCSG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVHIO
    B.5.2Functional name of contact pointVHIO CRS Unit Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressP.º Vall d’Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+349348930002432
    B.5.5Fax number+34934894212
    B.5.6E-mailmgonzalez@vhio.net
    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 Xgeva
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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.3.1Product nameDenosumab
    D.3.2Product code AMG 162
    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 INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameDENOSUMAB
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of breast cancer in women with a BRCA1 germline mutation
    Prevención del cáncer de mama en mujeres con una mutación germinal en BRCA1
    E.1.1.1Medical condition in easily understood language
    breast cancer
    cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 reduction in the risk of any breast cancer (invasive or DCIS) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
    Analizar en qué medida se reduce el riesgo de desarrollar cáncer de mama (invasivo o carcinoma ductal in situ) en las mujeres que presentan mutaciones en la línea germinal BRCA1 que han sido tratadas con denosumab en comparación con placebo
    E.2.2Secondary objectives of the trial
    • To determine the reduction in risk of invasive breast cancer
    • To determine the reduction in risk of invasive triple negative breast cancer (TNBC)
    • To determine the reduction in risk of ovarian, fallopian and peritoneal cancers (in women who have not undergone PBSO)
    • To determine the reduction in the risk of other (i.e. non-breast and non-ovarian) malignancies, including those known to be associated with BRCA1 germline mutations
    • To compare rates of breast biopsies and rate of benign breast lesions
    in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
    • To determine the reduction in the risk of clinical fractures in pre- and postmenopausal women with germline BRCA1 mutation who are treated with denosumab compared to placebo
    - Analizar la reducción del riesgo de desarrollar cáncer de mama invasivo en mujeres con mutaciones germinales en BRCA1 que han sido tratadas con denosumab en comparación con placebo
    - Analizar la reducción del riesgo de desarrollar cáncer de mama triple negativo (TNBC)
    - Analizar la reducción del riesgo de desarrollar cáncer de ovario, en las trompas de falopio y peritoneal (en mujeres que no se hayan sometido a una ooforectomía bilateral preventiva)
    - Analizar la reducción del riesgo de desarrollar otros tipos de cáncer (tumores que no sean de mama u ovario) incluyendo aquellos que se sabe están asociados a mutaciones en la línea germinal BRCA1
    - Analizar la reducción del riesgo de sufrir fracturas clínicas en mujeres postmenopáusicas que presentan mutaciones en la línea germinal BRCA1
    - Comparar la tasa de biopsias de mama y lesiones benignas de mama en mujeres que presentan mutaciones en la línea germinal BRCA1 que han sido tratadas con denosumab en comparación con un placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (Variant class 4 or 5)
    • Age ≥ 25 years and ≤ 55 years at randomization
    • No evidence of breast cancer by MRI or MG and clinical breast examination within the last 6 months prior to randomization
    • No clinical evidence of ovarian cancer at randomization
    • Negative pregnancy test at randomization for women of childbearing potential
    • No preventive breast surgery planned at time of randomization
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Written informed consent before any study-specific procedure is performed
    - Mujeres con una mutación en la línea germinal BRCA 1 (clase de variante 4 o 5) que se sospecha puede ser o se ha confirmado que es deletérea.
    - Edad ≥ 25 años y ≤ 55 años en el momento de la aleatorización.
    - Confirmación de ausencia de cáncer de mama mediante RMN o mamografía y examen clínico de mama en los seis meses anteriores a la aleatorización.
    - Ausencia de evidencias de cáncer de ovario en el momento de la aleatorización.
    - Test de embarazo negativo en el momento de la aleatorización en las mujeres en edad fértil.
    - Pacientes que no se vayan a someter a una cirugía preventiva programada de mama en el momento de la aleatorización.
    - Estado funcional ECOG (Eastern Cooperative Oncology Group ) de 0 o 1.
    · Consentimiento informado por escrito previo a la realización de cualquier prueba.
    E.4Principal exclusion criteria
    • Prior bilateral mastectomy
    • History of ovarian cancer (including fallopian and peritoneal cancer)
    • History of breast cancer
    • History of invasive cancer except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer, atypical hyperplasia or LCIS (Lobular Carcinoma In Situ)
    • Pregnant or lactating women (within the last 2 months prior to randomization)
    • Unwillingness to use highly effective contraception method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential. (Note: Women of childbearing potential should be monitored for pregnancy prior to each denosumab/placebo injection)
    • Clinically relevant hypocalcaemia (history and current condition), or serum calcium <2.0 mmol/L (<8.0 mg/dL)
    Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be ‘corrected’ before dosing the subject). Monitoring of calcium level in regular intervals (usually prior to IP administration) is highly recommended
    • Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior HRT is permitted)
    • Prior use of denosumab
    • Subject has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction within 3 months of enrollment
    • Concurrent treatment with a bisphosphonate or an anti-angiogenic agent
    • Any major medical or psychiatric condition that may prevent the subject from completing the study
    • Known active infection with Hepatitis B virus or Hepatitis C virus
    • Known infection with human immunodeficiency virus (HIV)
    • Use of any other investigational product (current or prior Aspirin or NSAIDs are permitted)
    - Mastectomía bilateral previa.
    - Antecedentes de cáncer de ovario (incluyendo el cáncer de trompas de falopio y peritoneal).
    - Antecedentes de cáncer de mama.
    - Antecedentes de cáncer invasivo, a excepción del cáncer o carcinoma cervical de células basales o células escamosas, el cáncer papilar o folicular de tiroides en estadío 1, hiperplasia atípica o LCIS (carcinoma lobular in situ).
    - Mujeres embarazadas o en periodo de lactancia (en los dos meses anteriores a la aleatorización).
    - Negativa a emplear un método anticonceptivo altamente eficaz durante al menos los cinco meses posteriores a la interrupción de la terapia con denosumab/placebo en mujeres en edad fértil. (Nota: Antes de cada inyección de denosumab/placebo, se deberá realizar un test de embarazo a las mujeres en edad fértil).
    - Hipocalcemia clínicamente relevante (antecedentes o actualmente), o calcio sérico <2.0 mmol/L (<8.0 mg/dL). Hipocalcemia definida como niveles alterados de calcio (un solo valor por debajo del límite normal no significa necesariamente que la paciente tenga hipocalcemia, aunque dichos niveles deberán ser “corregidos” antes de administrar el fármaco). Se recomienda encarecidamente vigilar periódicamente los niveles de calcio normalmente, antes de la administración PI).
    - Haber tomado Tamoxifeno, raloxifeno o inhibidores de aromatasa en los tres meses anteriores a la aleatorización o durante más de tres años en total (se permite haber tomado o estar tomando terapia hormonal sustitutiva).
    - Haber recibido denosumab con anterioridad.
    - Antecedentes conocidos o evidencia actual de osteonecrosis u osteomielitis mandibular, o presentar una enfermedad dental/mandibular que requiera cirugía, incluida la extracción de piezas dentales, en los tres meses posteriores a la inclusión en el estudio.
    - Tratamiento concomitante con bisfostonato o un agente antiangiogénico.
    - Cualquier enfermedad médica o psiquiátrica que pudiera impedir que la participante concluya el estudio.
    - Infección activa conocida por el virus de la hepatitis B o C.
    - Infección activa por el virus de inmunodeficiencia adquirida (VIH).
    - Uso de cualquier otro producto experimental (se permite haber tomado o estar tomando aspirina o AINEs)
    E.5 End points
    E.5.1Primary end point(s)
    • Time to the occurrence of any breast cancer (invasive or DCIS)
    Tiempo transcurrido hasta el desarrollo de un cáncer de mama (invasivo o ductal in situ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from randomization to the occurrence of breast cancer (invasive or DCIS)
    Desde la randomización hasta la aparición de cáncer de mama (invasivo o ductal in situ)
    E.5.2Secondary end point(s)
    • Time to invasive breast cancer
    • Time to invasive triple negative breast cancer
    • Time to ovarian, fallopian and peritoneal cancer (in women who have not undergone PBSO)
    • Time to other (non breast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations
    • Time to clinical fractures in pre- and postmenopausal women
    • Frequency of breast biopsies and frequency of benign breast lesions
    · Tiempo transcurrido hasta el desarrollo de un cáncer de mama invasivo
    · Tiempo transcurrido hasta el desarrollo de un cáncer de mama triple negativo.
    · Tiempo transcurrido hasta el desarrollo de un cáncer de ovario, trompas de falopio y peritoneal (en mujeres que no se hayan sometido a una ooforectomía bilateral preventiva).
    · Tiempo transcurrido hasta el desarrollo de otros tipos de cáncer (que no sean de mama o de ovario), incluyendo aquellos relacionados con las mutaciones en BRCA1.
    · Tiempo transcurrido hasta sufrir una fractura clínica en mujeres pre y postmenopáusicas.
    · Frecuencia de la realización de biopsias de mama y del desarrollo de lesiones benignas de mama.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time-to-event
    Hasta la ocurrencia del evento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Germany
    Israel
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is the date when the last patient has completed their end of study visit, all data have been collected, and all queries have been resolved.
    Fecha en la que la última paciente ha completado la visita de fin de estudio, todos los datos han sido recogidos y todas las queries han sido resueltas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years12
    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: 2918
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1450
    F.4.2.2In the whole clinical trial 2918
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standard after care outside of the protocol
    práctica clínica habitual fuera del protocolo de ensyao
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ANZ Breast Cancer Trials Group Limited
    G.4.3.4Network Country Australia
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Uniklinik Köln
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Catalan Institute of Oncology, Hospital Duran i Reynals
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Manchester Academic Health Science Centre, The University of Manchester
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Shaare Zedek Medical Centre
    G.4.3.4Network Country Israel
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Alliance for Clinical Trials in Oncology (Alliance)
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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