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    Summary
    EudraCT Number:2019-004074-25
    Sponsor's Protocol Code Number:ABc2
    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:2020-10-07
    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 number2019-004074-25
    A.3Full title of the trial
    A Phase II Open-Label Randomized COntrolled Pre-Surgical Feasibility Study of Antibiotic COmbinations in Early Breast Cancer
    Studio di Fase II, randomizzato, in aperto, controllato, pre-chirurgico di fattibilità del trattamento antibiotico combinato nel tumore mammario in fase precoce
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of antibiotics in early breast cancer
    Valutazione di combinazione di antibiotici nel tumore mammario in fase precoce
    A.3.2Name or abbreviated title of the trial where available
    ABC2
    ABC2
    A.4.1Sponsor's protocol code numberABc2
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    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 supportLunella Biotech
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU Pisana
    B.5.2Functional name of contact pointS.D. Anatomia Patologica I Universi
    B.5.3 Address:
    B.5.3.1Street AddressVia Roma, 57
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56126
    B.5.3.4CountryItaly
    B.5.4Telephone number050992984
    B.5.5Fax number050992984
    B.5.6E-mailgiuseppe.naccarato@med.unipi.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.2.1.2Country 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 nameAzitromicina
    D.3.2Product code [x]
    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 INNAZITROMICINA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameAzitromycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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.2.1.2Country 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 namevitamina C
    D.3.2Product code [x]
    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.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameASCORBIC ACID
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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: 3
    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.2.1.2Country 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 nameDoxiciclina
    D.3.2Product code [x]
    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 INNDOXICICLINA ICLATO
    D.3.9.2Current sponsor codeDoxicicline
    D.3.9.3Other descriptive nameDoxicicline
    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 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 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
    We investigated, in a population of patients with breast cancer, the combined effect of azithrocyn, docyciclin and vitamin C on biomarkers associated with cell proliferation
    In una popolazione con tumore precoce alla mammella sarà investigato ll'effetto combinato di azitromicina, doxiciclina e vitamina C sui bomarcatori associati alla proliferazione cellulare.
    E.1.1.1Medical condition in easily understood language
    women with breasat cancer who require a surgical treatment of the disease
    donne con tumore al seno che necessitano di trattamento chirurgico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10079328
    E.1.2Term Breast tumor excision
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess whether the DAV combination treatment reduces the proliferative activity of ther tumor, measured with an immunohistochemical method using anti-ki67 antibody
    valutare se il trattamento di combinazione DAV riduce l’attività proliferativa del tumore, misurata con metodica immunoistochimica con anticorpo anti ki67.
    E.2.2Secondary objectives of the trial
    (1) to evaluate the effect of the DAV combination treatment with respect to changes in stem cell markers (ALDH, CD44 / 24), differentiation (nuclear and histological grade), mitochondrial mass (TOMM20), senescence (beta -galactosidase, lipofuscin), of apoptosis (Cleaved caspase 3, TUNEL assay), of angiogenesis (CD31), of regulation of the cell cycle (p27), measured with immunistochemical method, comparing the values on the tumor tissue obtained with preoperative biopsy and subsequently on whole tumor surgically removed; (2) to evaluate the molecular basis of possible resistance to antibiotic treatment; (3) identify and monitor the presence of circulating tumor cells (CTC); (4) assessing the effect of treatment on disease-free interval; (5) assessing whether the DAV combination treatment is more effective than the Doxycycline alone therapy (6) assessing the safety and tolerability of the DAV regime.
    Obiettivi secondari: (1) valutare l’effetto del trattamento di combinazione DAV rispetto alle variazioni dei marcatori di staminalità (ALDH, CD44/24), di differenziamento (grado nucleare ed istologico), di massa mitocondriale (TOMM20), di senescenza (beta-galattosidasi, lipofuscina), di apoptosi (Cleaved caspase 3, TUNEL assay), di angiogenesi (CD31), di regolazione del ciclo cellulare (p27), misurati con metodica immunistochimica, confrontandone i valori sul tessuto tumorale ottenuto con biopsia preoperatoria e successivamente sull’intero tumore asportato chirurgicamente; (2) valutare le basi molecolari della eventuale resistenza al trattamento antibiotico; (3) individuare e monitorare la presenza di cellule tumorali circolanti (CTC); (4) valutare l’effetto del trattamento sull’intervallo libero di malattia; (5) valutare se il trattamento di combinazione DAV risulta più efficace rispetto alla terapia con la sola Doxiciclina (6) valutare la sicurezza e tollerabilità del regime DAV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) accession through informed consent; (2) WHO Performance Status 0-1; (3) ability to swallow; (4) adult females; (5) Clinical stage 1-3 AJCC; (6) planned surgical intervention in accordance with the timing of the trial; (7) normal kidney and liver function; (8) diagnosis of invasive carcinoma verified by biopsy.
    Criteri di inclusione: (1) adesione tramite consenso informato; (2) WHO Performance Status 0-1; (3) capacità di deglutire conservata; (4) femmine adulte; (5) Stadio clinico 1-3 operabile sec. AJCC; (6) intervento chirurgico programmato in accordo con i tempi della sperimentazione; (7) funzionalità renale ed epatica nella norma; (8) diagnosi di carcinoma invasivo accertata tramite biopsia.
    E.4Principal exclusion criteria
    (1) previous treatments for breast cancer or other malignancies (except malignant skin tumors other than melanoma); (2) surgical treatments or antibiotics in the 4 weeks prior to entering the trial; (3) known intolerance or allergy to the drugs being tested; (4) presence of severe or uncontrolled systemic diseases; (5) concomitant neoadjuvant therapy; (6) surgery scheduled less than two weeks after the signing of the informed consent; (7) pregnancy or breastfeeding; (8) concomitant therapies with drugs capable of interacting with Doxycycline, Azithromycin or Vitamin C; (9) inability to understand and to wish; (10) homeless patients; (11) history of abuse or dependence on alcohol and / or drugs; (12) deficiency of the enzyme glucose 6P dehydrogenase.
    (1) precedenti trattamenti per carcinoma mammario o altre neoplasie maligne (ad esclusione di tumori maligni della cute diversi dal melanoma); (2) trattamenti chirurgici o antibiotici nelle 4 settimane precedenti all’ingresso nella sperimentazione; (3) intolleranza o allergia note ai farmaci in sperimentazione; (4) presenza di malattie sistemiche severe o non controllate; (5) concomitante terapia neoadiuvante; (6) intervento chirurgico programmato a meno di due settimane dalla firma del consenso informato; (7) gravidanza o allattamento; (8) terapie concomitanti con farmaci capaci di interagire con la Doxiciclina, la Azitromicina o la Vitamina C, inclusi i contraccettivi; (9) incapacità di intendere e di volere; (10) pazienti senza fissa dimora; (11) storia d abuso o di dipendenza da alcol e/o droga; (12) deficienza dell’enzima glucosio 6P deidrogenasi.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in Ki67 expression in post-treatment tumor samples compared to pre-treatment tumor core biopsies (from the same patient). Post-treatment samples will also be compared with untreated samples
    il trattamento di combinazione DAV riduce l’attività proliferativa del tumore, misurata con metodica immunoistochimica con anticorpo anti ki67.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End points will be evaluated at the diagnosis (bioptic material, pretreatment evaluation) and in the surgically-removed tumour tissue (post-treatment evaluation).
    Lendpoint sarà valutato alla diagnosi (materiale bioptico, valutazioni pretrattamento) e nel tessuto tumorale rimosso tramite chirurgia ( valutazione post trattamento)
    E.5.2Secondary end point(s)
    In post-treatment compared to pre-treatment patient tumor samples, as well as in post-treatment compared to untreated patient tumor samples:
    • Reduction in cancer stem cell markers (ALDH, CD44/24)
    • Increase in tumor differentiation markers (Nuclear grading and histological grading)
    • Reduction in mitochondrial markers (such as TOMM20)
    • Reduction in angiogenesis markers (CD31)
    • Reduction in senescence markers (beta-galactosidase and lipofuscin)
    • Increase in apoptotic markers (p27, cleaved caspase 3 and TUNEL)
    In post-treatment compared to pre-treatment patient blood samples:
    • Decreased levels of circulating tumor cells
    In post-treatment compared to pre-treatment patients:
    • Tumor mass is decreased
    In post-treatment compared to untreated patient tumor samples:
    • Alterations in genetic profiling
    • Alterations in proteomics profiling
    In post-treatment compared to untreated patients:
    • Elevated blood levels and tumor tissue levels of DAV (doxycycline, azithromycin and vitamin C)
    • Blood levels of CA15.3 are <30 U/ml at follow up every 4 months for the first 3 years and then every 6 months for the following two years
    • Radiological follow up (yearly mammography and ultrasound) show no signs of recurrence for 5 years
    In tumor samples from post-treatment patients compared to treated patients from the ABC trial
    using z-test for two proportions.
    • The reduction in cancer stem cells markers is enhanced as compared to data collected with the ABC trial
    Endpoint secondari: (1) il trattamento di combinazione DAV riduce i marcatori di staminalità (ALDH, CD44/24), modifica il differenziamento (grado nucleare ed istologico), riduce la massa mitocondriale (TOMM20), modifica i marcatori di senescenza (beta-galattosidasi, lipofuscina), di apoptosi (Cleaved caspase 3, TUNEL assay), di angiogenesi (CD31), di regolazione del ciclo cellulare (p27), misurati con metodica immunistochimica; (2) delineare le basi molecolari della eventuale resistenza al trattamento di combinazione DAV; (3) il trattamento di combinazione DAV riduce il numero di cellule tumorali circolanti (CTC); (4) il trattamento di combinazione DAV allunga l’intervallo libero di malattia; (5) il trattamento di combinazione DAV risulta più efficace rispetto alla terapia con la sola Doxiciclina (6) il trattamento di combinazione DAV risulta sicuro e tollerabile.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End points will be evaluated at the diagnosis (bioptic material, pretreatment evaluation) and in the surgically-removed tumour tissue (post-treatment evaluation).
    Gli endpoints saranno valutati alla diagnosi (materiale bioptico, valutazione pretrattamento) e nel tessuto tumorale rimosso dopo intervento chirurgico ( valutazione post trattamento)
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nessun trattamento
    any treatment
    E.8.2.4Number of treatment arms in the trial2
    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
    For each patient, the study will be completed at the end of treatment and of follow up. The study will be considered concluded when patient enrollment is completed. This decision will be made by the investigators.
    Per ogni paziente lo studio sarà considerato concluso alla fine del trattamento e del follow up. Lo studio sarà considerato concluso quando l'arruolamento sarà completato. La decisione sarà presa dai ricercatori.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 90
    F.1.3Elderly (>=65 years) No
    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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    For each patient, the study will be completed at the end of treatment ad of follow up
    per ogni paziente lo studio sarà completato alla fine del trattamento e del follow up
    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 Decision2020-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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