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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   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:2018-002514-12
    Sponsor's Protocol Code Number:FACILE
    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:2021-01-20
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002514-12
    A.3Full title of the trial
    Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in elderly patients with hormone receptor positive/HER2 negative advanced breast cancer

    FACILE: FeAsibility of first-line riboCIclib in oLdEr patients with advanced breast cancer
    Studio di fase II, multicentrico, a braccio singolo, per valutare la fattibilità della combinazione di ribociclib e un inibitore dell’aromatasi non steroideo, in prima linea in anziani affetti da carcinoma mammario avanzato con recettori ormonali positivi/HER2 negativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combined treatment (hormone and biological therapy) for patients with advanced breast cancer with hormone (HR) positive and HER2 negative receptors
    Trattamento combinato (terapia ormonale + biologica) per i pazienti con carcinoma mammario avanzato con recettori ormonali (HR) positivi ed HER2 negativo
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberFACILE
    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 supportNovartis Farma S.p.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL Toscana Centro, Nuovo Ospedale di Prato
    B.5.2Functional name of contact pointSOC Oncologia Medica
    B.5.3 Address:
    B.5.3.1Street Addressvia Suor Niccolina 20
    B.5.3.2Town/ cityPrato
    B.5.3.3Post code59100
    B.5.4Telephone number0574802531
    B.5.5Fax number0574802903
    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 Kisqali
    D. of the Marketing Authorisation holderNovartis Europharma LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameKisqali
    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 INNRibociclib
    D.3.9.2Current sponsor codeNon applicabile
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    HR+, HER2 negative advanced breast cancer
    carcinoma mammario avanzato HR positivo HER2 negativo
    E.1.1.1Medical condition in easily understood language
    advanced 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    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
    • To assess the feasibility of first-line treatment with ribociclib plus NSAI in a cohort of older patients with advanced breast cancer.
    • Valutare la fattibilità di un trattamento di prima linea con ribociclib e NSAI in una coorte di pazienti anziani con tumore mammario avanzato.
    E.2.2Secondary objectives of the trial
    • Treatment adherence
    • Safety and tolerability
    • Patient reported outcomes (PROs)
    • Overall response rate (ORR)
    • Progression free survival (PFS)
    • Aderenza al trattamento
    • Sicurezza e tollerabilità
    • Risultati riportati dai pazienti (patient reported outcomes - PROs)
    • Tasso di risposta globale (overall response rate – ORR)
    • Progressione libera da malattia (progression free survival – PFS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients male or female, aged 70 years-old or older at the time of informed consent.
    2. Patients with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
    3. Measurable or not measurable but evaluable disease according to RECIST criteria 1.1
    4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
    5. Patient has a HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
    1. Pazienti di sesso maschile o femminile, di età pari o superiore a 70 anni al momento della firma del consenso informato.
    2. Pazienti con carcinoma mammario avanzato (recidivato localmente o metastatico) non suscettibili di terapia curativa.
    3. Malattia misurabile o non misurabile ma valutabile in base ai criteri RECIST 1.1.
    4. Diagnosi istologicamente e/o citologicamente confermata di carcinoma mammario con positività del recettore estrogenico e/o progestinico da parte del laboratorio locale.
    5. Carcinoma mammario HER2 negativo definito mediante test di ibridazione in situ negativo o uno stato immunoistochimico (IHC) di 0, 1+ o 2+. In caso di valore IHC è 2+, è richiesto un test di ibridazione in situ negativo (FISH, CISH o SISH) presso il laboratorio locale.
    E.4Principal exclusion criteria
    Patients eligible for this study must not meet any of the following criteria:
    1. Patient has received prior treatment with chemotherapy or hormonal therapy (except for neoadjuvant/ adjuvant chemotherapy), or any CDK4/6 inhibitor.
    - Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease-free interval must be greater than 12 months from the completion of treatment until study entry.
    - Patients who received = 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
    2. Patient has a known hypersensitivity to any of the excipients of ribociclib or NSAI
    3. Patient in concurrently using other anti-cancer therapy.
    4. Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade = 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
    5. Patient who has received extended-field radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to start of treatment, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator’s discretion). Patient from whom = 25% of the bone marrow has been previously irradiated are also excluded
    6. Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
    1. Pazienti che hanno ricevuto precedenti trattamenti con chemioterapia o terapia endocrina (eccetto nel setting neoadiuvante o adiuvante) o qualunque inibitore di CDK 4/6.
    - I pazienti che hanno ricevuto terapie (neo)adiuvanti per tumore mammario sono eleggibili. Se la precedente terapia (neo)adiuvante comprendeva letrozolo o anastrozolo, l’intervallo libero da malattia (DFS) deve essere maggiore di 12 mesi dalla conclusione del trattamento sino all’ingresso in studio.
    - I pazienti che hanno ricevuto = 28 giorni di letrozolo o anastrozolo per precedente malattia avanzata prima dell’inclusione in questo studio sono eleggibili.
    2. Pazienti che hanno una nota ipersensibilità a qualunque eccipiente del ribociclib o del letrozolo o dell’anastrozolo.
    3. Pazienti sottoposti ad altre terapie anti-tumorali.
    4. Pazienti che non hanno avuto risoluzione di tutti gli effetti tossici acuti di precedenti terapie anti-tumorali sino a un grado = 1 secondo CTCAE versione 5.0 (eccetto alopecia o altre tossicità non considerate un rischio per la sicurezza del paziente a discrezione dell’investigatore).
    5. Pazienti che hanno ricevuto radioterapia a campo esteso = 4 settimane o radiazioni circoscritte limitate per palliazione = 2 settimane prima dell'inizio del trattamento e che non hanno recuperato al grado = 1 dagli effetti indesiderati correlati a tale terapia (con l'eccezione di alopecia o altre tossicità non considerate un rischio per la sicurezza del paziente a discrezione dello sperimentatore). Sono esclusi anche i pazienti dei quali è stato irradiato = 25% del midollo osseo.
    6. Pazienti con una neoplasia concomitante o precedente sino a 3 anni prima dell'inizio dello studio, ad eccezione di carcinoma basocellulare o squamocellulare adeguatamente trattato o tumore cutaneo non melanomatoso o neoplasia della cervice uterina resecato in modo curativo.
    E.5 End points
    E.5.1Primary end point(s)
    The treatment feasibility will be evaluated as the proportion of patients not having experienced disease progression (PD), still on treatment with ribociclib plus NSAI 6 months after the first drug administration.
    La fattibilità del trattamento sarà valutata come la proporzione di pazienti, che non hanno avuto progressione di malattia (PD), ancora in trattamento con ribociclib e letrozolo o anastrozolo 6 mesi dopo la loro prima somministrazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after the first drug administration
    6 mesi dalla prima somministrazione
    E.5.2Secondary end point(s)
    Treatment adherence
    Aderenza al trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after the first drug administration
    a 6 mesi dalla prima somministrazione
    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 Yes
    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. 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 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 concerned15
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 194
    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 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 state194
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 194
    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)
    clinical practice
    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 Decision2019-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-12
    P. End of Trial
    P.End of Trial StatusOngoing
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