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    The EU Clinical Trials Register currently displays   43890   clinical trials with a EudraCT protocol, of which   7298   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2012-002707-18
    Sponsor's Protocol Code Number:EFFECT
    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:2012-10-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-002707-18
    A.3Full title of the trial
    EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer
    EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer
    EFFECT: Studio randomizzato di fase II multicentrico disegnato per valutare l'efficacia e l'impatto sulla funzione di due diversi livelli di dosi di nab-paclitaxel in donne anziane affette da carcinoma della mammella avanzato
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberEFFECT
    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.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 supportcelgene corporation
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL 4 Prato
    B.5.2Functional name of contact pointOncologia Medica
    B.5.3 Address:
    B.5.3.1Street Addressvia Mazzamuti 7
    B.5.3.2Town/ cityPrato
    B.5.3.3Post code59100
    B.5.4Telephone number+390574-434766
    B.5.5Fax number+390574-434540
    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. name ABRAXANE*INF 100MG 5MG/ML
    D. of the Marketing Authorisation holderCELGENE Srl
    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.3.4Pharmaceutical form Concentrate for solution for injection/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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Patients aged 65 years or older with histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy
    prima linea di trattamento per il carcinoma della mammella avanzato nelle donne di età ≥65 anni
    E.1.1.1Medical condition in easily understood language
    Patients aged 65 years or older with breast cancer, locally recurrent and/or metastatic
    prima linea di trattamento per il carcinoma della mammella avanzato nelle donne di età ≥65 anni
    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 PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 evaluate the efficacy and impact on functional status of two different doses of nab-paclitaxel
    • Sopravvivenza libera da eventi (EFS). Un evento è definito come progressione di malattia o morte o comparsa di una limitazione funzionale (definita come perdita di almeno una funzione alle ADL/IADL rispetto al basale confermata al ciclo successivo e ritenuta legata al trattamento dall’investigatore)
    E.2.2Secondary objectives of the trial
    Secondary objectives
    To evaluate the objective response rate (CR+PR) on the two nab-paclitaxel treatment arms
    To evaluate the clinical benefit rate (CR+PR+SD) on the two nab-paclitaxel treatment arms
    To evaluate the duration of progression-free survival and overall survival on the two nab-paclitaxel treatment arms
    To evaluate the safety and tolerability for the two dosing regimens
    • valutare il tasso di risposta obiettiva (CR + PR) dei due regimi di nab-paclitaxel in pazienti con malattia misurabile
    • valutare il tasso di beneficio clinico (CR + PR + SD) per i due regimi terapeutici in pazienti con malattia misurabile
    • valutare la durata della sopravvivenza libera da progressione e sopravvivenza per i due regimi
    • valutare la sicurezza e la tollerabilità dei due regimi alle diverse dosi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
    • Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria (see Appendix B) [Eisenhauer]
    • Age ≥ 65 years
    • Female
    • ECOG performance status 0-2
    • Estimated life expectancy of ≥ 12 weeks
    o Staging CT or MRI brain is required only if clinically indicated
    • Adequate organ function
    • No significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria)
    • No clinically significant comorbidities including: uncontrolled cardiac arrhythmias (with the exception of rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
    • No other malignancy within the last 5 years, with the exception of adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
    • No requirements for concomitant medications or therapies that may potential interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
    • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
    1) Diagnosi istologica o citologica di tumore della mammella localmente avanzato e / o metastatico, indipendentemente dallo stato recettoriale, HER2 negativo o HER2 positivo, con controindicazione alla terapia anti-HER2 (es. scompenso cardiaco congestizio).
    2) malattia misurabile o valutabile secondo i criteri RECIST 1.1
    3) Donna di età ≥ 65 anni
    4) ECOG performance status 0-2
    5) Aspettativa di vita stimata ≥ 12 settimane
    6) Adeguata funzione d'organo,
    7) Nessun pre-esistente neuropatia periferica significativa (significativa neuropatia periferica è definita come grado ≥ 2 su CTCAE v4.0 criteri)
    8) Assenza di comorbidità clinicamente significative, tra cui: aritmie cardiache non controllate (tranne fibrillazione atriale cronica), classe NYHA III o IV insufficienza cardiaca, diabete non controllato, ipertensione o altre condizioni mediche che possono interferire con la valutazione della tossicità
    9) Nessuna altra neoplasia negli ultimi 5 anni, con l'eccezione di tumori benigni della pelle, neoplasia cervicale intraepiteliale o carcinoma cervicale in situ
    10) Nessun requisito per i farmaci o terapie concomitanti che possono potenzialmente interagire con l'agente di prova. Qualsiasi farmaco controindicato deve essere sospeso almeno 14 giorni prima dell'ingresso in studio
    11) Assenza di qualsiasi condizione psicologica, familiare, sociologica o geografica che potenzialmente ostacolano il rispetto del protocollo di studio e il follow-up
    12) Consenso informato scritto secondo le ICH / GCP e nazionali / locali in vigore prima della registrazione / randomizzazione.
    E.4Principal exclusion criteria
    - active/symptomatic CNS metastases
    - previous chemotherapy for breast cancer in the advanced setting
    - metastasi del sistema nervoso centrale sintomatiche
    - precedente chemioterapia per malattia metastatica/avanzata
    E.5 End points
    E.5.1Primary end point(s)
    Event-free survival (EFS) where an event is either disease progression or death or decline in functional status
    sopravvicenza libera da eventi
    E.5.1.1Timepoint(s) of evaluation of this end point
    42 months
    42 mesi
    E.5.2Secondary end point(s)
    • Objective response rate (ORR)
    • Clinical benefit rate (CBR)
    • Progression free survival (PFS)
    • Overall survival (OS)
    • Incidence of Adverse events
    • valutare il tasso di risposta obiettiva
    • valutare il tasso di beneficio clinico (CR + PR + SD)
    • valutare la durata della sopravvivenza libera da progressione e sopravvivenza per i due regimi
    • valutare la sicurezza e la tollerabilità dei due regimi
    E.5.2.1Timepoint(s) of evaluation of this end point
    42 mesi
    42 mesi
    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 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 Yes
    E.6.13.1Other scope of the trial description
    impact on function
    impatto sulla funzione
    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. 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. description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 No
    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
    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 months42
    E.8.9.1In the Member State concerned 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 state156
    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)
    standard therapy
    al termine della loro partecipazione i soggetti riceveranno la terapia standard del centro presso il quale sono seguiti
    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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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