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    Summary
    EudraCT Number:2019-002015-26
    Sponsor's Protocol Code Number:ACT16106
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-06
    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 number2019-002015-26
    A.3Full title of the trial
    Phase 2 window study of two dose levels of SAR439859 (SERD) versus letrozole in newly diagnosed preoperative post-menopausal patients with ER positive, HER2 negative primary breast cancer
    Estudio ventana fase 2 de dos niveles de dosis de SAR439859 (SERD) versus Letrozol en pacientes post-menopáusicas recién diagnosticadas con cáncer de mama primario con RE positivo, HER2 negativo previa intervención quirúrgica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of SAR439859 versus letrozole in ER positive, HER2 negative pre-operative post-menopausal primary breast cancer
    Estudio de SAR439859 versus Letrozol en cáncer de mama primario post-menopáusico, con RE positivo, HER2 negativo previa intervención quirúrgica.
    A.4.1Sponsor's protocol code numberACT16106
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1228-9473
    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 SponsorSANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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.3.2Product code SAR439859
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSAR439859
    D.3.9.2Current sponsor codeSAR439859
    D.3.9.4EV Substance CodeSUB186740
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Femara®, Letrozole 2.5 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    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 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.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
    Cancer
    Cáncer
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term 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 determine whether SAR439859 given at 2 different doses improves the antiproliferative activity when compared to letrozole
    Determinar si SAR439859 administrado en 2 dosis diferentes mejora la actividad antiproliferativa en comparación con letrozol.
    E.2.2Secondary objectives of the trial
    -To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms
    -To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms
    -To assess safety in the three treatment arms
    -Evaluar la proporción de participantes con una disminución relativa desde el inicio en porcentaje de células tumorales positivas probadas por inmunohistoquímica superior o igual al 50% (Ki67 superior o igual al 50%) en los tres brazos de tratamiento
    -Evaluar la degradación del receptor de estrógeno (RE) en biopsias en participantes en los tres brazos de tratamiento
    -Evaluar la seguridad en los tres brazos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histological or cytological proven diagnosis of invasive breast adenocarcinoma
    -Localized breast cancer eligible for immediate breast conservative surgery: Stage II or operable Stage III (excludes T4) as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017
    -Postmenopausal women as defined by one of the following:
    -Age ≥60 years
    -Age <60 years with: spontaneous cessation of menses >12 months; or with cessation of menses of duration ≤12 months or secondary to hysterectomy and have follicle stimulating hormone (FSH) level in the postmenopausal range; or who have received hormonal replacement therapy but have discontinued this treatment and have FSH level in the postmenopausal range; or with status post bilateral surgical oophorectomy; or postbilateral ovarian ablation through pelvic radiotherapy; or are premenopausal women on a gonadotropin-releasing hormone (GnRH) analog for at least 4 weeks (to be continued during study treatment)
    -Breast tumor size of at least 10 mm in short axis measured by ultrasound
    -Primary tumor must be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor by immunohistochemistry
    -Ki67 level of at least 15% at diagnosis from immunohistochemistry of the tumor
    -Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    -Diagnóstico histológico o citológico comprobado de adenocarcinoma de mama invasivo
    -Cáncer de mama localizado elegible para cirugía conservadora de mama inmediata: Etapa II u Etapa III operable (excluye T4) como se define en el American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017
    -Mujeres posmenopáusicas según lo definido por uno de los siguientes:
    -Edad superior o igual a 60 años
    -Edad inferior a 60 años con: cese espontáneo de la menstruación de más de 12 meses; o con el cese de la menstruación de duración inferior o igual a 12 meses o secundaria a la histerectomía y tener un nivel de hormona folículo estimulante (FSH) en el rango posmenopáusico; o que han recibido terapia de reemplazo hormonal pero han descontinuado este tratamiento y tienen un nivel de FSH en el rango posmenopáusico; o con estado post ooforectomía quirúrgica bilateral; o ablación ovárica posbilateral mediante radioterapia pélvica; o son mujeres premenopáusicas en un análogo de la hormona liberadora de gonadotropina (GnRH) durante al menos 4 semanas (se continuará durante el tratamiento del estudio)
    - Tamaño del tumor de mama de al menos 10 mm en eje corto medido por ultrasonido
    -El tumor primario debe ser positivo para los receptores de estrógeno (RE +) y negativo para el receptor HER2 (HER2-) por inmunohistoquímica
    - Nivel de Ki67 de al menos 15% en el momento del diagnóstico por inmunohistoquímica del tumor
    -Estado 0-1 en la Eastern Cooperative Oncology Group (ECOG)
    E.4Principal exclusion criteria
    Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859 or letrozole; Participants unable to swallow normally and to take capsules or tablets
    -Participant with any other cancer; adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed
    -Evidence of metastatic spread by standard assessment according to local practice
    -Treatment with strong or moderate Cytochrome P450 3A (CYP3A) or CYP2C8 inducers within 2 weeks before first study treatment administration or 5 elimination half-lives whichever is longest
    -Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (P-gp)
    -Use of any investigational agent within 4 weeks prior to randomization
    -Currently receiving (and unwilling to discontinue) hormone replacement therapy (last dose <14 days prior to randomization)
    -Prior anti-cancer treatment is not allowed unless it was completed at least 1 year prior to inclusion into this trial
    -Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments)
    -Inadequate hematological or renal function
    -Prothrombin time/international normalized ratio (INR) >1.5 x ULN) or outside therapeutic range if receiving anticoagulation that would affect the prothrombin time/INR
    -Any of the following abnormal liver function test results: Aspartate aminotransferase >1.5 x upper limit of normal (ULN); Alanine aminotransferase >1.5 x ULN; Total bilirubin >1.5 x ULN
    -Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
    -Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
    Historial médico o trastornos gastrointestinales en curso que puedan afectar la absorción de SAR439859 o letrozol; participantes no pueden tragar normalmente y tomar cápsulas o comprimidos.
    -Participante con cualquier otro cáncer; se permite el tratamiento adecuado del cáncer de piel de células basales o de células escamosas o cáncer cervical in situ o cualquier otro cáncer del que el participante haya estado libre de enfermedad durante más de 3 años
    -Evidencia de diseminación metastásica por evaluación estándar de acuerdo con la práctica local.
    -Tratamiento con inductores de citocromo P450 3A (CYP3A) o CYP2C8 fuertes o moderados dentro de las 2 semanas antes de la administración del primer tratamiento de estudio o 5 vidas medias de eliminación, lo que sea más largo
    -Tratamiento continuo con medicamentos que son sustratos sensibles de la glicoproteína P (P-gp)
    -Uso de cualquier agente de investigación dentro de las 4 semanas previas a la aleatorización
    -Actualmente recibiendo (y no dispuesto a suspender) la terapia de reemplazo hormonal (última dosis inferior a14 días antes de la aleatorización)
    -El tratamiento anticancerígeno previo no está permitido a menos que se haya completado al menos 1 año antes de su inclusión en este ensayo
    -Tratamiento sistémico o local previo para el nuevo cáncer de mama primario actualmente bajo investigación (incluyendo cirugía, radioterapia, tratamientos citotóxicos y endocrinos)
    - Función hematológica o renal inadecuada.
    -Tiempo de protrombina / relación normalizada internacional (INR)> 1.5 x ULN) o fuera del rango terapéutico si recibe anticoagulación que afectaría el tiempo de protrombina / INR
    -Cualquier de los siguientes resultados anormales de las pruebas de función hepática: aspartato aminotransferasa> 1.5 x límite superior de la normalidad (ULN); Alanina aminotransferasa> 1.5 x ULN; Bilirrubina total> 1.5 x ULN
    - Participantes que sean empleados del centro del estudio clínico u otras personas directamente involucradas en la realización del estudio, o miembros de la familia inmediata de dichas personas.
    -Sensibilidad a cualquiera de las intervenciones del estudio, o sus componentes, o al medicamento u otra alergia que, en opinión del investigador, contraindica la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Ki67: Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry) after a 14-day treatment period compared to baseline assessed by central reading
    El cambio en Ki67 (porcentaje de células tumorales positivas analizadas por inmunohistoquímica [IHQ]) después de un período de tratamiento de 14 días en comparación con los valores iniciales evaluados mediante una lectura central.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Day 15
    Basal y día 15
    E.5.2Secondary end point(s)
    1. Ki67≥50%: Proportion of participants with relative change from baseline in Ki67≥50% after a 14-day treatment period compared to baseline
    2. ER Expression: Change in ER expression after a 14-day treatment period compared to baseline
    3. Adverse Events (AEs)/Serious Adverse Events (SAEs): Percentage of participants with AEs/SAEs
    4. Clinical Laboratory Test Abnormalities: Percentage of participants with clinical laboratory test abnormalities
    1. Ki67≥50%: Proporción de participantes con una disminución relativa desde el inicio en el marcador de proliferación Ki67 después de un período de 14 días de tratamiento en comparación con el valor inicial.
    2. Expresion RE: Cambio en la expresión del RE después de un período de tratamiento de 14 días en comparación con el valor inicial.
    3. Evaluar la seguridad en los tres grupos de tratamiento Acontecimiento Adversos (AA)/Acontecimientos Adversos Graves (AAG): Porcentaje de participantes con AA/AAG
    4. Anormalidades de laboratorio: Porcentaje de participantes con anormalidades de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and Day 15
    2. Baseline and Day 15
    3. Up to approximately Day 44
    4. Up to Day 14
    1. Basal y día 15
    2. Basal y día 15
    3. Hasta aproximadamente el día 44
    4. Hasta el día 14
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Belgium
    France
    Italy
    Russian Federation
    Spain
    United States
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 160
    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)
    None
    Ninguno
    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 Decision2020-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-05-28
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