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    Summary
    EudraCT Number:2010-021067-32
    Sponsor's Protocol Code Number:BO25430(TDM4529g)
    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:2011-12-28
    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 number2010-021067-32
    A.3Full title of the trial
    AN OPEN LABEL, MULTICENTER EXTENSION STUDY OF TRASTUZUMAB-MCC-DM1 (T-DM1) ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI CANCER THERAPIES IN PATIENTS PREVIOUSLY TREATED WITH THE EQUIVALENT T-DM1 REGIMEN IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD.–SPONSORED T-DM1 STUDY
    STUDIO DI ESTENSIONE MULTICENTRICO, IN APERTO CON TRASTUZUMAB-MCC-DM1(T-DM1) SOMMINISTRATO IN MONOTERAPIA O IN ASSOCIAZIONE CON ALTRI TRATTAMENTI ANTINEOPLASTICI IN PAZIENTI PRECEDENTEMENTE TRATTATI IN UNO STUDIO SPONSORIZZATO DA GENENTECH E/O F. HOFFMAN-LA ROCHE LTD, CON LO STESSO REGIME CHEMIOTERAPICO COMPRENDENTE T-DM1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN OPEN LABEL, MULTICENTER EXTENSION STUDY OF T-DM1 ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI CANCER THERAPIES IN PATIENTS PREVIOUSLY TREATED WITH THE EQUIVALENT T DM1 REGIMEN IN A GENENTECH AND /OR F. HOFFMANN-LA ROCHE LTD. – SPONSORED T-DM1 STUDY
    STUDIO DI ESTENSIONE MULTICENTRICO, IN APERTO CON T-DM1 SOMMINISTRATO IN MONOTERAPIA O IN ASSOCIAZIONE CON ALTRI TRATTAMENTI ANTINEOPLASTICI IN PAZIENTI PRECEDENTEMENTE TRATTATI IN UNO STUDIO SPONSORIZZATO DA GENENTECH E/O F. HOFFMAN-LA ROCHE LTD, CON LO STESSO REGIME CHEMIOTERAPICO COMPRENDENTE T-DM1.
    A.3.2Name or abbreviated title of the trial where available
    T-DM1 Extension study
    Studio di estensione con T-DM1
    A.4.1Sponsor's protocol code numberBO25430(TDM4529g)
    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 SponsorROCHE
    B.1.3.4CountryItaly
    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.4.1Name of organisation providing supportGenentech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROCHE S.p.A
    B.5.2Functional name of contact pointEthics & Administrative Trial Unit
    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 number.
    B.5.5Fax number039-2475085
    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-MCC-DM1 (T-DM1)
    D.3.2Product code RO5304020/F02
    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.3.9.1CAS number 1018448-65-1
    D.3.9.2Current sponsor codeRO5304020
    D.3.9.3Other descriptive nameT-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.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 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 namepertuzumab (rhuMAb 2C4)
    D.3.2Product code RO4368451/F01
    D.3.4Pharmaceutical form Concentrate 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 INNPERTUZUMAB
    D.3.9.1CAS number 380610-27-5
    D.3.9.2Current sponsor codeRO4368451
    D.3.9.3Other descriptive nameruhMAb 2C4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale umanizzato
    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
    Metastatic Breast Cancer
    Carcinoma metastatico della mammella
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Cancer
    Carcinoma metastatico della mammella
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic 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 14.1
    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
    - To provide continued T-DM1 therapy as single agent T-DM1 or in combination with paclitaxel or with pertuzumab ± paclitaxel to HER2-positive breast cancer patients who were previously enrolled in a Genentech/Roche-sponsored T-DM1 study and who derived benefit from the therapy administered in the parent study (patients must demonstrate no evidence of systemic disease progression and an acceptable safety profile at the completion of the parent study or at the time of the parent study closure.) - To collect safety data with regard to long-term administration of single agent T-DM1 or T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel.
    •Prolungare la somministrazione di T-DM1 in monoterapia o in associazione con paclitaxel o con pertuzumab ± paclitaxel, in pazienti affetti da carcinoma mammario HER2-positivo precedentemente arruolati in uno studio con T-DM1 sponsorizzato da Genentech/Roche e che hanno tratto beneficio dal trattamento somministrato nello studio originario (i pazienti non devono presentare alcuna evidenza di progressione sistemica della patologia e devono dimostrare un profilo di sicurezza accettabile al completamento o alla chiusura dello studio originario). •Raccogliere dati di sicurezza circa la somministrazione a lungo termine di T-DM1 in monoterapia o T-DM1 in associazione con paclitaxel o con pertuzumab ± paclitaxel.
    E.2.2Secondary objectives of the trial
    Not applicable
    NON APPLICABILE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Completed single-agent T-DM1 or combination T-DM1 treatment on the parent study or who continue to receive single-agent T-DM1 or combination T-DM1 treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks prior to the first scheduled dose of study therapy on the extension study; - Expectation by the investigator that the patient may continue to benefit from additional single-agent T-DM1 or combination T-DM1 treatment; - Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy.
    - Pazienti che hanno concluso il trattamento con T-DM1 come singolo agente o in combinazione nell’ambito dello studio originario o pazienti che continuano a ricevere T-DM1 come singolo agente o in combinazione al momento della chiusura dello studio originario e che hanno ricevuto l’ultima dose di farmaco nelle 6 settimane antecedenti la prima dose di farmaco sperimentale programmata nell’ambito dello studio di estensione; - Pazienti che, secondo la valutazione dello sperimentatore, possono continuare a beneficiare di un trattamento con T-DM1 come singolo agente o in combinazione; - Donne potenzialmente fertili e uomini con partner potenzialmente fertili, devono essere disposti ad usare un metodo contraccettivo non ormonale altamente efficace, o due forme di contraccezione non ormonali efficaci, e ne continuino l’uso di contraccezione per tutta la durata dello studio e per almeno 6 mesi dopo l’ultima dose di farmaco assunta. Uomini le cui partner sono in stato di gravidanza dovrebbero usare il preservativo per tutta la durata della gravidanza.
    E.4Principal exclusion criteria
    -Adverse events leading to single-agent T-DM1 or combination T-DM1 treatment discontinuation in the parent study; -Ongoing serious adverse events from the parent study; -Progressive disease (except for isolated brain metastases under certain conditions as described in Section 3.1) on single-agent T-DM1 or a T-DM1−containing regimen during parent study or before starting the extension study; -Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0;
    -History of symptomatic congestive heart failure ([CHF]; New York Heart
    Association [NYHA] Classes II−IV), ventricular arrhythmia requiring treatment,current unstable angina, or history of myocardial infarction within 6 months prior to study entry;
    -Severe dyspnea at rest due to complications of advanced malignancy
    or current requirement for continuous oxygen therapy;
    -Current severe, uncontrolled systemic disease (e.g., clinically significant
    cardiovascular, pulmonary, or metabolic disease);
    -Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment;
    -Current pregnancy or lactation;
    -History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g.,chemotherapy, Herceptin, etc.) since the patient’s last study drug dose in the parent study;
    -History of hypersensitivity with previous T-DM1 or any agent used with T-DM1 in the parent study, precluding further dosing;
    -Assessed by the investigator to be unable or unwilling to comply with
    the requirements of the protocol.
    -Eventi avversi correlati all’interruzione del trattamento con T-DM1 come singolo agente o in combinazione nell’ambito dello studio originario;
    -Eventi avversi seri che hanno avuto inizio durante lo studio originario e che sono ancora in corso;
    -Progressione di malattia (ad eccezione delle metastasi cerebrali isolate in particolari condizioni come descritto nella sezione 3.1) verificatasi durante il trattamento con T-DM1 come singolo agente o con un regime di terapia contenente T-DM1 nell’ambito dello studio originario o prima dell’inizio dello studio di estensione; -Neuropatia periferica di grado ≥ 3 secondo i criteri NCI-CTCAE versione 3.0;
    -Anamnesi di insufficienza cardiaca congestizia di classe II-IV secondo i criteri della New York Heart Association - NYHA, aritmia ventricolare che richiede trattamento, angina instabile in atto o storia di infarto miocardico nei 6 mesi precedenti l’ingresso nello studio;
    -Dispnea grave a riposo conseguente a complicazioni della neoplasia avanzata o in atto richiedente ossigenoterapia in maniera continuativa;
    -Malattia sistemica in atto, grave, non controllata (per esempio malattia cardiovascolare, polmonare o metabolica clinicamente significativa);
    -Interventi di chirurgia maggiore o traumi significativi nei 28 giorni antecedenti l’ingresso in studio o anticipata necessità di intervento chirurgico durante il trattamento in studio;
    -Gravidanza o allattamento in atto;
    -Anamnesi di trattamento sperimentale o altro trattamento sistemico per la cura del cancro (per esempio chemioterapia, Herceptin etc.) dopo l’ultima dose di farmaco sperimentale ricevuto nell’ambito del protocollo originario;
    -Anamnesi di ipersensibilità al T-DM1 o ad altro agente usato in combinazione con T-DM1 nello studio originario che preclude la somministrazione di ulteriori dosi;
    -Pazienti valutati dallo sperimentatore non in grado di seguire i requisiti del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of adverse events leading to T-DM1 discontinuation or dose reduction. - Incidence of all adverse events and serious adverse events.
    - Incidenza degli eventi avversi che comportano l’interruzione o la riduzione della dose di T-DM1. - Incidenza di tutti gli eventi avversi e degli eventi avversi seri.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study
    Fine dello studio
    E.5.2Secondary end point(s)
    Not applicable
    NON APPLICABILE
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    NON APPLICABILE
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Argentina
    Brazil
    Canada
    Chile
    Israel
    Mexico
    Peru
    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
    Treatment can continue until the earlier of the following outcomes: disease progression (with the exception of pts with isolated brain metastases under certain conditions, as described in Section 3.1 of the protocol), unacceptable toxicity, study closure.
    Il trattamento potrà continuare fino a qunado uno dei seguenti eventi si verifichi per primo: progressione di malattia (ad eccezione delle metastasi cerebrali isolate, come descritto nel protocollo sez.3.1),tossicità inaccettabile, chiusura studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 100
    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 may receive study treatment until disease progression (with the exception of isolated brain metastases) or unacceptable toxicity. The study is expected to remain open until after the last patient’s last visit has occurred. Patients randomized to non-T DM1−containing treatment arms of T-DM1 trials are not eligible for this study.
    I pazienti possono ricevere il trattamento in studio fino a progerssone di malattia (ad eccezione delle metastasi cerebrali isolate)o a comparsa di tossicità inaccettabile. Lo studio rimarrà aperto fino all’effettuazione dell’ultima visita per l’ultimo paziente. Non sono eleggibili per questo studio i pazienti che sono stati randomizzati nei bracci di trattamento non contenente T-DM1 nelle precedenti sperimentazioni cliniche su T-DM1.
    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 Decision2011-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-07
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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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