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    Summary
    EudraCT Number:2021-005081-17
    Sponsor's Protocol Code Number:ARV-471-BC-201
    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:2022-08-29
    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 number2021-005081-17
    A.3Full title of the trial
    An Open-Label, Randomized, Non-Comparative Phase 2 Study of ARV-471 or Anastrozole in Post-Menopausal Women With ER+/HER2– Breast Cancer in the Neoadjuvant Setting
    Estudio de Fase 2 abierto, aleatorizado y no comparativo de ARV-471 o anastrozol en mujeres posmenopáusicas con cáncer de mama ER+/HER2– en el entorno neoadyuvante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 trial using ARV-471 or Anastrozole in Post-Menopausal Women with Breast Cancer Prior to Surgery.
    Ensayo de fase 2 usando ARV-471 o anastrozol en mujeres postmenopáusicas con cáncer de mama antes de la cirugía.
    A.4.1Sponsor's protocol code numberARV-471-BC-201
    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 SponsorArvinas Estrogen Receptor, Inc. (Arvinas)
    B.1.3.4CountryUnited States
    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 supportArvinas Estrogen Receptor, Inc. (Arvinas)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArvinas Estrogen Receptor, Inc.
    B.5.2Functional name of contact pointClinical Trials Information Desk
    B.5.3 Address:
    B.5.3.1Street Address5 Science Park, 395 Winchester Avenue
    B.5.3.2Town/ cityNew Haven
    B.5.3.3Post codeCT 06511
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialinformationdesk@arvinas.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 nameARV-471
    D.3.2Product code ARV-471
    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 INNARV-471
    D.3.9.1CAS number 2229711-68-4
    D.3.9.2Current sponsor codeARV-471
    D.3.9.3Other descriptive name(3S)-3-[6-[4-[[1-[4-[(1R,2S)-6-hydroxy-2-phenyl-1,2,3,4-tetrahydronaphthalen-1-yl]phenyl]piperidin-4-yl]methyl]piperazin-1-yl]-3-oxo-1H-isoindol-2-yl]piperidine-2,6-dione
    D.3.9.4EV Substance CodeSUB260708
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Anastrozole Teva
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma Belgium N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameAnastrozole
    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 INNAnastrozole
    D.3.9.3Other descriptive nameAnastrozole
    D.3.9.4EV Substance CodeSUB05502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Post-menopausal women with ER+ HER2- breast cancer.
    Mujeres postmenopáusicas con cáncer de mama ER+ y HER2-.
    E.1.1.1Medical condition in easily understood language
    Breast cancer in post-menopausal women.
    Cáncer de mama en mujeres posmenopáusicas.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083232
    E.1.2Term HER2 negative 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
    Evaluate the effects of ARV-471 and anastrozole, respectively, on Ki-67 expression in tumors after 2 weeks of treatment.
    Evaluar los efectos de ARV-471 y anastrozol, respectivamente, sobre la expresión de Ki-67 en los tumores después de 2 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    1. Evaluate the safety and tolerability of ARV-471 and anastrozole, respectively.
    2. Evaluate the clinical and pathological response of ARV-471 and anastrozole, respectively.
    1. Evaluar la seguridad y la tolerabilidad de ARV-471 y anastrozol, respectivamente.
    2. Evaluar la respuesta clínica y anatomopatológica de ARV-471 y anastrozol, respectivamente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Post-menopausal females > or = 18 years.
    2. Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment).
    3. Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer.
    4. The primary tumor must be at least 1.5 cm by imaging.
    5. Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection.
    6. Capable of giving signed informed consent.
    7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    8. Adequate bone marrow function.
    9. Activated partial thromboplastin time (aPTT) < or = 1.25 × upper limit of normal (ULN) and international normalized ratio (INR) < or = 1.25.
    10. Adequate renal function defined as serum creatinine of < or = 1.5 × ULN or an estimated creatinine clearance of > or = 50 mL/min by Cockcroft Gault.
    11. Adequate liver function.
    12. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    1. Mujeres posmenopáusicas > o = 18 años.
    2. Cáncer de mama ER+ y HER2- confirmado histológica o citológicamente (según la evaluación local).
    3. Cáncer de mama clínico T1c-T4c, N0-N2, M0 tributario de resección quirúrgica definitiva, sin presencia de carcinoma in situ ductal bilateral ni cáncer de mama invasivo.
    4. El tumor primario debe medir como mínimo 1,5 cm en las pruebas de imagen.
    5. Disposición para someterse a una biopsia de selección, una biopsia durante el tratamiento y a la resección quirúrgica.
    6. Capaz de dar el consentimiento informado firmado.
    7. Estado funcional ECOG de 0 o 1.
    8. Función de la médula ósea adecuada.
    9. TTPa < o = 1,25 × LSN e INR < o = 1,25.
    10. Función renal adecuada, definida como una concentración de creatinina sérica < o = 1,5 × LSN o un aclaramiento de creatinina estimado > o = 60 ml/min usando la fórmula de Cockcroft-Gault.
    11. Función hepática adecuada.
    12. Participantes que estén dispuestos y sean capaces de cumplir con todas las visitas programadas, plan de tratamiento, pruebas de laboratorio, consideraciones de estilo de vida y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    1. Any other active malignancy within three years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
    2. Any of the following in the previous six months:
    - Myocardial infarction.
    - Severe / unstable angina.
    - Coronary / peripheral artery bypass graft.
    - Symptomatic congestive heart failure (New York Heart Association class III or IV).
    - Cerebrovascular accident.
    - Transient ischemic attack.
    - Symptomatic pulmonary embolism.
    3. Any of the following in the previous six months:
    - Congenital long QT syndrome.
    - Torsade de Pointes.
    - Sustained ventricular tachyarrhythmia and ventricular fibrillation.
    - Left anterior hemiblock (bifascicular block).
    - Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) > or = Grade 2.
    - Atrial fibrillation of any grade (> or = Grade 2 in the case of asymptomatic lone atrial fibrillation).
    4. Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery.
    5. Cirrhosis meeting criteria for Child Pugh B and C.
    6. Major surgery (as defined by the Investigator) within four weeks of first dose of study drug.
    7. History of allergy or reaction to any of the drug components for ARV-471 or anastrozole.
    8. Inability to take oral medication without crushing, dissolving, or chewing tablets.
    9. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    10. Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents.
    11. Any live vaccines within 14 days of planned start of first dose of study drug.
    12. Taking the following agents within 14 days of C1D1 unless otherwise specified:
    - Sensitive P-glycoprotein (P-gp) substrates or P-gp substrates with narrow therapeutic indices.
    - Strong CYP3A4 inhibitors or inducers.
    - Any medications with known QT risk, and/or are associated with a risk of Torsades de Pointes, within 7 days of C1D1.
    13. Corrected QT interval by Fredericia’s method (QTcF) > 470 msec.
    14. Participants with active, uncontrolled bacterial, fungal or viral infection, including (but not limited to) hepatitis B virus (HBV) and hepatitis C virus (HCV) and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
    15. Participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Sponsor approval is required).
    16. Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
    17. Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    1. Diagnóstico de cualquier otra neoplasia maligna dentro de los 3 años previos a la inclusión, a excepción del cáncer de piel de células basales o escamosas o el carcinoma in situ de cérvix.
    2. Cualquiera de los siguientes dentro de los 6 meses previos:
    - Infarto de miocardio.
    - Angina inestable grave.
    - Bypass de las arterias coronarias/periférico.
    - Insuficiencia cardíaca congestiva sintomática (clase III o IV de la New York Heart Association).
    - Accidente vascular cerebral.
    - Accidente isquémico transitorio.
    - Embolismo pulmonar sintomático.
    3. Cualquiera de los siguientes dentro de los 6 meses previos:
    - Síndrome de QT largo congénito.
    - Torsade de Pointes.
    - Taquiarritmia ventricular mantenida o fibrilación ventricular.
    - Hemibloqueo anterior izquierdo (bloqueo bifascicular).
    - Disritmias cardíacas en curso ≥ Grado 2 de los CTCAE del NCI.
    - Fibrilación auricular de cualquier grado (≥ Grado 2 en caso de una fibrilación auricular asintomática aislada).
    4. Enfermedad inflamatoria intestinal activa, diarrea crónica, enfermedad diverticular conocida y no controlada, resección gástrica previa o cirugía bariátrica con colocación de banda gástrica.
    5. Cirrosis que cumpla los criterios de Child Pugh B o C.
    6. Cirugía mayor (definida según el criterio del investigador) realizada dentro de las 4 semanas previas a la primera administración del fármaco del estudio.
    7. Antecedentes de alergia o reacción a cualquiera de los componentes de ARV-471 o anastrozol.
    8. Incapacidad para ingerir medicación por vía oral a menos que los comprimidos se trituren, disuelvan o mastiquen.
    9. Otras condiciones médicas o psiquiátricas incluyendo recientes (dentro del ultimo año) o idea/comportamiento suicida o anormalidades de laboratorio que ponga en riesgo la participación en el estudio o, a juicio del investigador que considere el participante inapropiado para participar.
    10. Tratamiento previo para el cáncer de mama que incluya terapia sistémica (p.ej., quimioterapia, terapia hormonal), radioterapia, cirugía o cualquier fármaco en investigación.
    11. Cualquier vacuna con microorganismos vivos administrada dentro de los 14 días previos al inicio previsto de la administración del fármaco en estudio.
    12. Toma de los siguientes agentes dentro de los 14 días previos a C1D1, a menos que se especifique lo contrario:
    - Sustratos sensibles a P-gp o sustratos de P-gp con índice terapéutico estrecho.
    - Inhibidores o inductores potentes del CYP3A4.
    - Cualquier medicación con riesgo conocido de afectación del QT y/o que se asocie a riesgo de aparición de Torsades de Pointes, administrada dentro de los 7 días previos al C1D1.
    13. Intervalo QT corregido por metodo Fredericia (QTcF)>470 msec.
    14.Participantes con infección bacteriana, fúngica o viral activa y no controlada, incluyendo (pero no limitada a) el virus de la hepatitis B (VHB) y el virus de la hepatitis C (VHC) y el virus de inmunodeficiencia humana conocido (VIH) o las enfermedades asociadas al síndrome de inmunodeficiencia adquirida (SIDA).
    15. Participantes en prisión (Nota: bajo ciertas circusntancias específicas una persona que ha estado encarcelada podria ser incluida o permitirse que continue como participante. Se requerirán la aprobacion del Promotor y las condiciones estrictas que apliquen).
    16. Los participantes que son arrestados obligatoriamente para recibir un tratamiento de enfermedad psiquiatrica o fisica (ej. enfermedad infecciosa).
    17. Personal del centro investigador o empleados del promotor directamente involucrados en el estudio, personal del centro supervisados por el investigador o sus respectivos miembros familiares.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in Ki-67 expression between baseline and Cycle 1 Day 15 tumor biopsies.
    Porcentaje de cambio en la expresión de Ki-67 entre la situación basal y las biopsias tumorales del D15 del C1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 1 Day 15, i.e. after two weeks of treatment.
    Día 15 del ciclo 1, es decir después de dos semanas de tratamiento.
    E.5.2Secondary end point(s)
    1. Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation.
    2. Pathologic stage, pathologic complete response (pCR) rate, and modified Pre-operative Endocrine Prognostic Index (mPEPI) score at the time of surgical resection (C6D18 ± 10 days); rates of breast conserving surgery; radiographic response of the primary tumor based on imaging during cycle 6; caliper-based response on C6D1.
    1. Incidencia de todos los acontecimientos adversos, acontecimientos adversos graves y acontecimientos adversos que provocan la suspensión del fármaco en estudio.
    2. Estadio patológico, tasa de respuesta completa patológica (RCp) y puntuación del Índice Pronóstico Endocrino Preoperatorio modificado (PEPIm) en el momento de la resección quirúrgica (D18 del C6 ± 10 días); tasas de cirugía conservadora de la mama; respuesta radiológica del tumor primario basándose en las pruebas de imagen realizadas durante el ciclo 6; respuesta basada en las mediciones con calibrador del D1 del C6.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During entire duration of the trial.
    2. At end of trial participation.
    1. Durante toda la duración del ensayo.
    2. Al final de la participación en el ensayo.
    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 No
    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 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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    No están previstas comparaciones formales entre ARV-471 y anastrozol o pruebas de hipótesis
    No formal comparisons between ARV-471 and anastrozole or hypotheses testing are planned
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    United States
    Spain
    Germany
    Georgia
    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
    End of study is defined as the last participant’s last study visit or follow-up phone call.
    El final del estudio se define como la última visita de estudio o llamada telefónica de seguimiento del último participante.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 150
    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)
    The Sponsor will not provide study drugs to participants after they leave the study. Participants should continue their care as normally expected for participants with breast cancer.
    El Promotor no proporcionará los medicamentos del estudio a los participantes después de que salgan del estudio. Los participantes deben continuar su atención como se espera normalmente para los participantes con cáncer de mama.
    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 Decision2022-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
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