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    Summary
    EudraCT Number:2012-001628-37
    Sponsor's Protocol Code Number:MO28231
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-001628-37
    A.3Full title of the trial
    A multicenter, single arm study of trastuzumab emtansine (T-DM1) in HER2 positive locally advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment
    Studio multicentrico, a braccio singolo con trastuzumab emtansine (T-DM1) in pazienti affetti da carcinoma mammario HER2-positivo localmente avanzato o metastatico, che hanno ricevuto un precedente trattamento anti-HER2 e chemioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in patients with HER2-positive breast cancer that has spread and has not responded to one course of anti-cancer therapy.
    Studio in pazienti affetti da carcinoma mammario HER2-positivo che si è diffuso e non ha risposto a un ciclo di terapie antitumorali.
    A.4.1Sponsor's protocol code numberMO28231
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROCHE SPA
    B.5.2Functional name of contact pointMedical Affairs&Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039/2475070
    B.5.5Fax number039/2475084
    B.5.6E-mailitaly.info_cta@roche.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 nametrastuzumab emtansine (T-DM1)
    D.3.2Product code RO530-4020/F02-01
    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 INNtrastuzumab emtansine
    D.3.9.1CAS number 1018448-65-1
    D.3.9.2Current sponsor codeRO5304020
    D.3.9.3Other descriptive nameT-DM1, Trastuzumab-MCC-DM1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeConiugato farmaco-anticorpo composto da un anticorpo monoclonale umanizzato (trastuzumab) e DM1
    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
    HER2 positive metastatic breast cancer
    Carcinoma mammario HER2-positivo metastatico
    E.1.1.1Medical condition in easily understood language
    HER2 positive breast cancer that has spread
    Carcinoma mammario HER2-positivo che si è diffuso
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    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
    The primary objective of this study is to evaluate the safety and tolerability of trastuzumab emtansine.
    L'obiettivo primario dello studio è valutare la sicurezza e la tollerabilità di trastuzumab emtansine
    E.2.2Secondary objectives of the trial
    •Progression free survival (PFS) •Overall survival (OS) •Overall response rate (ORR)= partial response(PR)+complete response(CR) •Clinical benefit rate (CBR) •Duration of response (DoR) •Time To Response (TTR) Pharmacoeconomics outcome objective •Health Resource Utilization
    •Sopravvivenza libera da progressione (PFS) •Sopravvivenza globale (OS) •Tasso di risposta globale (ORR)=risposta parziale(PR)+risposta completa(CR) •Tasso di beneficio clinico (CBR) •Durata della risposta (DoR) •Tempo alla risposta (TTR) Obiettivi farmacoeconomici •Utilizzo delle risorse sanitarie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. HER2-positive disease determined locally i.e., IHC 3+ and/or gene-amplified by ISH as per institutional practice, (however, both tests should be performed wherever possible and only one positive result is required for eligibility) 2. Histologically or cytologically confirmed invasive BC 3. Prior treatment for BC in the advanced/metastatic, unresectable locally advanced or metastatic setting must include an anti-HER2 agent and chemotherapy in combination or sequential administration (complementary hormonal therapy is allowed) 4. Documented progression of incurable, unresectable, locally advanced, or mBC, defined by the investigator: progression must occur during or after most recent treatment for locally advanced/mBC or within 6 months after completing adjuvant therapy 5. Measurable and/or non-measurable disease 6. Signed written informed consent approved by the institution's independent Ethical Committee (EC) 7. Age ≥ 18 years 8. Left ventricular ejection fraction ≥ 50% by either ECHO or MUGA 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 10. Adequate organ function 11. For women of childbearing potential and men with partners of childbearing potential agreement by the patient and/or partner to use a highly effective non-hormonal form of contraception. 12. Negative serum pregnancy test for women of childbearing potential and for all women not meeting the definition of postmenopausal, and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential.
    1.Malattia HER2-positiva determinata localmente ovvero con punteggio immunoistochimico (IHC) pari a 3+ e/o amplificazione genica valutata con ibridazione in situ (ISH) in conformità alla pratica del centro (tuttavia, ove possibile, dovrebbero essere eseguiti entrambi i test e per l'idoneità è necessario un solo risultato positivo). 2.Carcinoma mammario invasivo confermato istologicamente o citologicamente. 3.Il trattamento precedente per il carcinoma mammario nel contesto adiuvante o nel contesto di malattia non resecabile, localmente avanzata o metastatica deve comprendere sia la chemioterapia, da sola o in associazione con un altro farmaco, sia un anti-HER2, da solo o in associazione con un altro farmaco (è ammessa la terapia ormonale complementare). 4.Progressione documentata di carcinoma mammario localmente avanzato o metastatico, incurabile e non resecabile secondo il giudizio dello sperimentatore: la progressione deve verificarsi durante o dopo il trattamento più recente per il carcinoma mammario localmente avanzato/metastatico o nei 6 mesi successivi al completamento della terapia adiuvante. 5.Malattia misurabile e/o non misurabile. 6.Consenso informato scritto firmato, approvato dal Comitato etico indipendente del centro. 7.Età ≥18 anni. 8.Frazione di eiezione ventricolare sinistra (LVEF) ≥ 50% misurata con ecocardiogramma (ECO) o esame MUGA. 9.Performance status sulla scala ECOG (Eastern Cooperative Oncology Group) 0, 1 o 2. 10.Funzionalità d'organo adeguata 11.Per le donne potenzialmente fertili e gli uomini con compagne potenzialmente fertili, accettazione da parte del/della paziente e/o del/della compagno/a a utilizzare un metodo anticoncezionale non ormonale altamente efficace o due metodi anticoncezionali non ormonali efficaci. 12.Risultato negativo del test di gravidanza sul siero per le donne potenzialmente fertili (comprese le donne in pre-menopausa sottoposte a legatura delle tube) e per tutte le donne che non soddisfano i criteri di post-menopausa (≥ 12 mesi di amenorrea) e che non sono state sottoposte a sterilizzazione chirurgica con isterectomia e/o ooforectomia bilaterale. Per tutte le altre donne, nell'anamnesi medica deve essere presente la documentazione che conferma che la paziente non è potenzialmente fertile
    E.4Principal exclusion criteria
    1. History of treatment with trastuzumab emtansine 2. Prior enrolment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not 3. History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above 4. History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria 5. History of exposure to the following cumulative doses of anthracyclines: • Doxorubicin or liposomal doxorubicin > 500 mg/m2 • Epirubicin > 900 mg/m2 • Mitoxantrone >120 mg/m2 • If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of 500 mg/m2 doxorubicin. 6. History of radiation therapy within 14 days of first study treatment. The patient must have recovered from any resulting acute toxicity (to Grade ≤ 1) prior to first study treatment. 7. CNS only disease 8. Brain metastases which are symptomatic. NOTE: A 14 days window after end of radiotherapy must be observed. Patient must not be receiving steroids to control symptoms. 9. History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment 10. History of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Classes II−IV) or serious cardiac arrhythmia requiring treatment 11. History of myocardial infarction or unstable angina within 6 months of first study treatment 12. Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy 13. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) 14. Pregnancy or lactation 15. Currently known active infection with HIV, hepatitis B virus, or hepatitis C virus 16. History of intolerance (such as Grade 3−4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins 17. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol throughout
    1.Anamnesi di trattamento con trastuzumab emtansine. 2.Arruolamento precedente in uno studio clinico con trastuzumab emtansine indipendentemente dal fatto di essere stati trattati o meno con tale farmaco. 3.Anamnesi di altra malignità negli ultimi 5 anni, fatta eccezione per i casi adeguatamente trattati di carcinoma in situ della cervice, carcinoma cutaneo non melanomatoso, carcinoma uterino in stadio 1, carcinoma mammario HER2-positivo sincrono o diagnosticato in precedenza o altre neoplasie con esito curativo simile a quelli sopra citati. 4.Anamnesi di trattamento con qualsiasi farmaco antitumorale/farmaco biologico o trattamento sperimentale nei 21 giorni precedenti al primo trattamento dello studio fatta eccezione per la terapia ormonale che può essere somministrata fino a 7 giorni prima del primo trattamento dello studio; recupero di eventuali tossicità correlate al trattamento secondo gli altri criteri di idoneità. 5.Anamnesi di esposizione alle seguenti dosi cumulative di antracicline: •Doxorubicina o doxorubicina liposomiale &gt; 500 mg/m2 •Epirubicina &gt; 900 mg/m2 •Mitoxantrone &gt;120 mg/m2 •Se è stata somministrata un'altra antraciclina o sono state somministrate più antracicline, la dose cumulativa non deve superare l'equivalente di 500 mg/m2 di doxorubicina. 6.Anamnesi di radioterapia nei 14 giorni precedenti al primo trattamento dello studio. Il/la paziente deve essersi ripreso/a da eventuale tossicità acuta (fino al grado ≤ 1) prima del primo trattamento dello studio. 7.Malattia che interessa solo il SNC. 8.Metastasi cerebrali sintomatiche. NOTA: deve essere rispettata una finestra di 14 giorni dalla fine della radioterapia. Il/la paziente non deve essere trattato/a con steroidi per controllare i sintomi 9.Anamnesi di diminuzione della LVEF a &lt;40% o insufficienza cardiaca congestizia sintomatica con il trattamento precedente contenente trastuzumab. 10.Anamnesi di insufficienza cardiaca congestizia sintomatica (Classi II-IV della New York Heart Association [NYHA]) o aritmia cardiaca seria che necessiti di trattamento. 11.Anamnesi di infarto miocardico o angina instabile nei 6 mesi precedenti al primo trattamento dello studio. 12.Dispnea a riposo in corso dovuta a complicazioni di una malignità avanzata o necessità di ossigenoterapia continuativa. 13.Malattia sistemica grave in corso, non controllata (ad es. malattia cardiovascolare, polmonare o metabolica clinicamente significativa). 14.Gravidanza o allattamento. 15.Infezione attiva accertata da HIV, virus dell'epatite B o virus dell'epatite C. 16.Anamnesi di intolleranza (ad esempio reazione di grado 3-4 all'infusione) o ipersensibilità a trastuzumab o alle proteine murine. 17.Soggetti che a giudizio dello sperimentatore non siano in grado o disposti a rispettare completamente i requisiti del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study will be AEs Grade ≥ 3, specifically, liver dysfunction, pneumonitis, allergic reactions, thrombocytopenia and all Grade ≥ 3 AEs related to trastuzumab emtansine.
    L'endpoint primario dello studio sarà costituito dagli Eventi Avversi di grado ≥ 3, in particolare disfunzione epatica, polmonite, reazioni allergiche, trombocitopenia e da tutti gli EA di grado ≥ 3 correlati a trastuzumab emtansine
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will be performed when all (1000) patients have been followed up for safety and efficacy for up to a period of 2 years after last patient enrolled in the trial.
    L'analisi finale sarà eseguita quando tutti i (1000) pazienti saranno stati sottoposti a follow up di sicurezza ed efficacia per un periodo massimo di 2 anni dopo l'arruolamento dell'ultimo paziente nella sperimentazione.
    E.5.2Secondary end point(s)
    Efficacy is the secondary endpoint. Efficacy endpoints will be: PFS, OS, ORR, CBR, duration of response, and time to tumor response.
    L'efficacia è l'endpoint secondario. Gli endpoint di efficacia saranno: PFS, OS, ORR, CBR, durata della risposta e tempo alla risposta del tumore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analysis will be performed when all (1000) patients have been followed up for safety and efficacy for up to a period of 2 years after last patient enrolled in the trial.
    L'analisi finale sarà eseguita quando tutti i (1000) pazienti saranno stati sottoposti a follow up di sicurezza ed efficacia per un periodo massimo di 2 anni dopo l'arruolamento dell'ultimo paziente nella sperimentazione.
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualità della vita
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned29
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA230
    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
    European Union
    Argentina
    Australia
    Brazil
    Canada
    Costa Rica
    Croatia
    Dominican Republic
    Ecuador
    El Salvador
    Guatemala
    Hong Kong
    India
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    Panama
    Peru
    Saudi Arabia
    Taiwan
    Trinidad and Tobago
    Turkey
    United Arab Emirates
    Venezuela, Bolivarian Republic of
    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 Patient Last Visit (LPLV) as per definition is the last data collection point which can be a clinic visit or a laboratory sample. LPLV is expected to occur two years after the last patient first visit.
    L'ultima visita dell'ultimo paziente(LPLV)è per definizione l'ultimo momento di raccolta dati, sia esso una visita medica o un prelievo di un campione per le analisi di laboratorio.LPLV è attesa si verifichi 2 anni dopo la prima visita ultimo pazien
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 860
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 880
    F.4.2.2In the whole clinical trial 1000
    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)
    Patients who have not progressed at the end of the trial will be offered options to continue with trastuzumab emtansine treatment, please see Section 4.2.4 of the protocol for further details.
    Ai pazienti che non avranno mostrato progressione alla fine della sperimentazione sarà offerta l'opzione di continuare il trattamento con trastuzumab emtansine, vedere la sezione 4.2.4 del protocollo per ulteriori dettagli.
    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 Decision2012-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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