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    Summary
    EudraCT Number:2021-000458-24
    Sponsor's Protocol Code Number:BREASTECT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000458-24
    A.3Full title of the trial
    Pilot study on electrochemotherapy in metastatic breast cancer (BREAST ECT)
    Studio pilota su elettrochemioterapia nel cancro della mammella metastatico (BREAST ECT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study on electrochemotherapy in metastatic breast cancer
    Studio pilota su elettrochemioterapia nel cancro della mammella metastatico
    A.3.2Name or abbreviated title of the trial where available
    BREAST ECT
    BREAST ECT
    A.4.1Sponsor's protocol code numberBREASTECT
    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 SponsorISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIstituto Nazionale Tumori di Napoli - IRCCS "G.Pascale"
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale Tumori di Napoli - IRCCS "G. Pascale"
    B.5.2Functional name of contact pointRaimondo Di Giacomo
    B.5.3 Address:
    B.5.3.1Street AddressVia Mariano Semmola, snc
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815903665
    B.5.6E-mailr.digiacomo@istitutotumori.na.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bleoprim
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Spa
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBleoprim - Bleomicina
    D.3.2Product code [Bleomicina]
    D.3.4Pharmaceutical form Powder and solvent 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 INNBleomicina
    D.3.9.1CAS number 11056-06-7
    D.3.9.2Current sponsor codeBleoprim
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeCombined with Electrochemotherapy
    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 during systemic therapy and in disease stability according to RECIST 1.1 criteria
    Carcinoma mammario metastatico in corso di terapia sistemica ed in stabilità di malattia secondo i criteri RECIST 1.1
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer
    Cancro della mammella metastatico
    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 LLT
    E.1.2Classification code 10006216
    E.1.2Term Breast carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Assessment of tolerability with questionnaire with a Likert scale with five options 0-5 (harmful, unbearable, hardly bearable, bearable, no problem) during the first 30 days (7-15-30 days).
    • Safety assessment (register of the nature and frequency of any unexpected intraoperative adverse events and related complications) within 24 hours after treatment.
    • Valutazione della tollerabilità con questionario con una scala Likert con cinque opzioni 0-5 (dannosa, insopportabile, poco sopportabile, sopportabile, nessun problema) durante i primi 30 giorni (7-15-30 giorni).
    • Valutazione della sicurezza (registro della natura e della frequenza di eventuali eventi avversi intraoperatori inattesi e relative complicanze) entro le 24h successive al trattamento.
    E.2.2Secondary objectives of the trial
    • Measurement of T (size of primary tumor) in mm with breast ultrasound and mammography with contrast medium (Omnipaque 350) (CESM) 60 days after treatment.
    • Pain assessment with questionnaire with a Likert scale with four options 0-4 (unbearable, hardly bearable, bearable, no problem) during the first 7 days.
    • Assessment of the quality of life through a visual analog scale (VAS) 0-100 (poor, not very good, fairly good, very good, excellent) during the first 30 days (7-15-30 days).
    • Evaluation of adverse events (fever, loco-regional infection, skin necrosis, haemorrhage) during the first 30 days after treatment.
    • Misurazione del T (dimensioni del tumore primitivo) in mm con ecografia mammaria e mammografia con mdc (Omnipaque 350) (CESM) a 60 gg dal trattamento.
    • Valutazione del dolore con questionario con una scala Likert con quattro opzioni 0-4 (insopportabile, poco sopportabile, sopportabile, nessun problema) durante i primi 7 giorni.
    • Valutazione della qualità della vita attraverso una scala analogica visuale (VAS) 0-100 (scadente, poco buona, abbastanza buona, molto buona, eccellente) durante i primi 30 giorni (7-15-30 giorni).
    • Valutazione degli eventi avversi (febbre, infezione loco-regionale, necrosi cutanea, emorragia) durante i primi 30 giorni dal trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years
    • Diagnosis of histologically confirmed breast cancer with intraparenchymal breast lesion
    • Stability of the disease assessed at the end of three cycles of systemic therapy regardless of the type of drug according to RECIST 1.1 criteria.
    • Stage IV of the disease according to TNM (VIII AJCC classification)
    • Performance status (PS) according to (ECOG) = 2
    • Signature of informed consent
    • Patients not randomized to other clinical trials
    • Età > 18 anni
    • Diagnosi di carcinoma mammario confermata istologicamente con lesione mammaria intraparenchimale
    • Stabilità di malattia valutata al termine di tre cicli di terapia sistemica indipendentemente dalla tipologia di farmaci secondo i criteri RECIST 1.1.
    • Stadio IV della malattia secondo TNM (VIII classificazione AJCC)
    • Performance status (PS) secondo (ECOG) = 2
    • Firma del consenso informato
    • Pazienti non randomizzati in altri studi clinici
    E.4Principal exclusion criteria
    • Carcinomatous Mastitis (IBC - T4d stage)
    • Neutrophils <1,000 / ml
    • Platelets <70,000 / mL
    • Hemoglobin = 9 gr / dl
    • Known allergy to Bleomycin
    • Cumulative dose of Bleomycin which exceeded 250 mg/m2
    • Infection in progress
    • Cardiac arrhythmia [severe conduction disorders such as type 2 and type 3 atrioventricular blocks and sino-atrial block]
    • History of Epilepsy
    • Pregnancy in progress
    • Patient unable to read or understand study documents
    • Patient with any disease or other significant clinical condition that, in the investigator's judgment, could interfere with the study assessments or with adequate participation in the study.
    • Patient in progression of the disease
    • Mastite Carcinomatosa (IBC – stadio T4d)
    • Neutrofili < 1,000/ml
    • Piastrine < 70,000/ml
    • Emoglobina = 9 gr/dl
    • Allergia nota alla Bleomicina
    • Dose cumulative di Bleomicina che ha superato i 250 mg/m2
    • Infezione in atto
    • Aritmia cardiaca [disordini severi della conduzione come blocchi atrioventricolari di tipo 2 e di tipo 3 e blocco seno-atriale]
    • Storia di Epilessia
    • Gravidanza in corso
    • Paziente incapace di leggere o comprendere i documenti dello studio
    • Paziente con qualsiasi malattia o altra condizione clinica significativa che, secondo il giudizio dello sperimentatore, potrebbe interferire con le valutazioni dello studio o con l’adeguata partecipazione allo studio.
    • Paziente in progressione di malattia
    E.5 End points
    E.5.1Primary end point(s)
    -Assessment of Tolerability
    Through a questionnaire with a Likert scale with five 0-5 alternatives (harmful, unbearable, hardly bearable, bearable, no problem).
    -Safety Assessment
    Register of the nature and frequency of any unexpected intraoperative adverse events and related postoperative complications within 24 hours after treatment
    -Valutazione della Tollerabilità
    Attraverso un questionario con una scala Likert con cinque alternative 0-5 (dannosa, insopportabile, poco sopportabile, sopportabile, nessun problema).
    -Valutazione della Sicurezza
    Registro della natura e della frequenza di eventuali eventi avversi intraoperatori inattesi e relative complicanze postoperatorie entro le 24h successive al trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tolerability: during the first 30 days (7-15-30 days)
    Safety: within 24 hours after treatment
    Tollerabilità: durante i primi 30 giorni (7-15-30 giorni)
    Sicurezza: entro 24h successive al trattamento
    E.5.2Secondary end point(s)
    Pain Assessment
    Prior to treatment and at each follow-up visit, a pain assessment will be performed using the VAS scale (visual analog scale anchored at 100 mm with 0 being "No Pain" and 100 mm "Worst Possible Pain"); Evaluation of side effects
    By reporting adverse events (such as fever, loco-regional infection, skin necrosis, haemorrhages) within 30 days of treatment using the classification "Common Terminology Criteria for Adverse Events Version 6.0 (CTCAE 4.0)"
    [https: //ctep.cancer .gov / protocolDevelopment / electronic_applications / ctc.htm].; Quality of life assessment
    The quality of life, measured by the QOL questionnaire, will be carried out at all controls.
    QOL is a tool developed in Europe and widely used, which serves to assess the general quality of life developed in Europe.
    The QOL descriptive system consists in expressing a preference for five parameters: mobility, self-care, usual activities, pain / discomfort and anxiety / depression. The QOL questionnaire also includes a visual analog scale (VAS), whereby respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status ).; Evaluation of effectiveness
    The evaluation will take place 7-15-30 days after treatment with clinical examination and 60 days with the performance of diagnostic tests (ultrasound, mammography with contrast medium (CESM) or MRI based on the diagnostic tests performed at baseline) .
    The measurement of T (primary tumor size) in mm will be compared with the baseline value.
    Valutazione del Dolore
    Prima del trattamento e ad ogni visita di follow-up sarà eseguita una valutazione del dolore utilizzando la scala VAS (scala analogica visiva ancorata a 100 mm con 0 che è "No Dolore" e 100 mm "Dolore peggiore possibile").; Valutazione degli effetti collaterali
    Attraverso la segnalazione di eventi avversi (quali febbre, infezione loco-regionale, necrosi cutanea, emorragie) entro 30 giorni dal trattamento usando la classificazione “Common Terminology Criteria for Adverse Events Version 6.0 (CTCAE 4.0)” [https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm].; Valutazione della Qualità della vita
    La qualità della vita, misurata dal questionario QOL, sarà effettuata a tutti i controlli.
    QOL è uno strumento sviluppato in Europa e ampiamente utilizzato, che serve a valutare la qualità generale della vita sviluppata in Europa.
    Il sistema descrittivo QOL consiste nell’esprimere una preferenza per cinque parametri: la mobilità, l'auto-cura, le attività abituali, il dolore / disagio e l'ansia / depressione. Il questionario QOL include anche una scala analogica visiva (VAS), in base alla quale gli intervistati possono riportare il loro stato di salute percepito con un voto compreso tra 0 (il peggior stato di salute possibile) a 100 (il miglior stato di salute possibile).; Valutazione dell’efficacia
    La valutazione avverrà a 7-15-30 giorni dal trattamento con esame clinico ed a 60 giorni con l’effettuazione di esami diagnostici (ecografia, mammografia con mezzo di contrasto (CESM) o Risonanza magnetica mammaria in base agli esami diagnostici effettuati al baseline).
    La misurazione del T (dimensioni del tumore primitivo) in mm sarà confrontata con il valore al baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Prior to treatment and at each follow-up visit; Within 30 days of treatment; At all check-ups; 7-15-30 days after treatment with clinical examination and 60 days with the performance of diagnostic tests
    Prima del trattamento e ad ogni visita di follow-up; Entro 30 giorni dal trattamento; A tutti i controlli; a 7-15-30 giorni dal trattamento con esame clinico ed a 60 giorni con l’effettuazione di esami diagnostici
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.1.1In 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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 13
    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)
    Subjects will be assisted according to the standard procedures of clinical practice
    I soggetti saranno assistiti secondo le procedure standard della pratica clinica
    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 Decision2021-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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