Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000419-17
    Sponsor's Protocol Code Number:AFT-38
    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:2021-01-29
    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 number2017-000419-17
    A.3Full title of the trial
    A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
    Studio randomizzato di fase III, in aperto, per valutare, dopo trattamento di induzione, l'efficacia e la sicurezza di palbociclib associato a terapia anti-HER2 ed endocrinoterapia vs terapia anti-HER2 associata a endocrinoterapia nei pazienti con carcinoma mammario metastatico, recettori ormonali positivi e HER2-positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
    Studio randomizzato di fase III, in aperto, per valutare, dopo trattamento di induzione, l'efficacia e la sicurezza di palbociclib associato a terapia anti-HER2 ed endocrinoterapia vs terapia anti-HER2 associata a endocrinoterapia nei pazienti con carcinoma mammario metastatico, recettori ormonali positivi e HER2-positivo
    A.3.2Name or abbreviated title of the trial where available
    AFT-38 (PATINA)
    AFT-38 (PATINA)
    A.4.1Sponsor's protocol code numberAFT-38
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02947685
    A.5.4Other Identifiers
    Name:Non applicabileNumber:Non applicabile
    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 SponsorAlliance Foundation Trials (AFT)
    B.1.3.4CountryUnited States
    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 supportPfizer, Inc - United States
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMichelangelo Tech srl
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia Agostino Bertani 14
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number+390287086420
    B.5.5Fax number+390234593887
    B.5.6E-mailclinical.operation@fondazionemichelangelo.org
    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 IBRANCE 125 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Labs, Division of Pfizer, Inc, NY, NY 10017
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIBRANCE
    D.3.2Product code [Non applicabile]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codeNon applicabile
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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.2.1.1.1Trade name IBRANCE 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Labs, Division of Pfizer, Inc, NY, NY 10017
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIBRANCE
    D.3.2Product code [IBRANCE 100 mg]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codenon applicabile
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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.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.2.1.1.1Trade name IBRANCE 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Labs, Division of Pfizer, Inc, NY, NY 10017
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIBRANCE
    D.3.2Product code [Non applicabile]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codeNon applicabile
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Metastatic carcinoma, hormone receptors positive and HER2-positive
    Carcinoma metastatico, recettori ormonali positivi e HER2-positivo
    E.1.1.1Medical condition in easily understood language
    Metastatic breast cancer
    Carcinoma mammario metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER2 positive 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 20.0
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor 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
    The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy in prolonging PFS in participants with hormone receptor-positive, HER2+ metastatic breast cancer who have not received any prior treatment beyond induction treatment in this setting.
    Dimostrare che la combinazione di palbociclib associato a terapia endocrina e terapia anti-HER2 è più efficace della combinazione con sola terapia endocrina e terapia anti-HER2 nel prolungare la sopravvivenza libera da progressione (PFS) nei pazienti con carcinoma mammario metastatico positivo per HER2 e recettori ormonali, non precedentemente trattate per malattia metastatica con l'eccezione del trattamento di induzione previsto per questo protocollo
    E.2.2Secondary objectives of the trial
    1. To compare measures of tumor control (including PFS, OR, CBR, DOR) between the treatment arms
    2. To compare median overall survival and overall survival probabilities at 3-years and 5-years between the treatment groups
    3. To compare safety and tolerability between the treatment arms
    4. To compare the incidence of CNS metastasis between the treatment arms
    5. To compare patient reported time to symptom progression as assessed by the FACT-B TOI-PFB
    6. To compare patient reported breast cancer specific health related quality of life (HRQOL) and general health status.
    1. Confrontare l’efficacia del trattamento [PFS, percentuale di risposte cliniche obiettive (OR), percentuale di beneficio clinico (CBR), durata della risposta (DOR)] tra i due bracci di trattamento
    2. Confrontare la sopravvivenza mediana e le probabilità di sopravvivenza a 3 e 5 anni tra i due bracci di trattamento
    3. Confrontare la sicurezza e la tollerabilità dei due bracci di trattamento
    4. Confrontare l’incidenza di metastasi al sistema nervoso centrale tra i due bracci di trattamento
    5. Confrontare il tempo al manifestarsi dei sintomi di progressione di malattia, attraverso valutazione riportata dai pazienti (Patient Reported Outcome, PRO), con FACT-B TOI-PBF
    6. Confrontare la valutazione riportata dai pazienti (PRO) per la qualità di vita specifica per carcinoma mammario (HRQOL) e per lo stato di salute in generale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed Informed Consent Form obtained prior to any study specific assessments and procedures
    Age =18 years
    Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer.
    Patients must have histologically confirmed HER2+ and ER+ and/or PR+, metastatic breast cancer.
    ECOG performance status 0-1
    Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.
    Serum or urine pregnancy test must be negative within 7 days in women of childbearing potential. Women of childbearing potential and male patients must use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib
    Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy regimen to NCI CTCAE version 4.0 Grade =1
    Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    Patients may or may not have received neo/adjuvant therapy, but must have a disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis =6 months.
    Patients must have received an acceptable, standard, chemotherapy containing anti-HER2 based induction therapy for the treatment of metastatic breast cancer. CT is limited to a taxane or vinorelbine (only for trastuzumab-based regimen). Eligible patients are expected to have completed 6 cycles of chemotherapy containing anti-HER2-therapy treatment. A min of 4 cycles of treatment is acceptable for patients experiencing significant toxicity associated with treatment as long as they are without evidence of disease progression (i.e. CR, PR or SD). The max number of cycles is 8. Patients are eligible provided they are without evidence of disease progression by local assessment (i.e. CR, PR or SD).
    Participants with a history of treated CNS metastases are eligible, if Disease outside the CNS is present; No evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study; No history of intracranial hemorrhage or spinal cord hemorrhage; Not requiring anti-convulsants for symptomatic control;Min of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and recovery from significant (G = 3) acute toxicity with no ongoing requirement for corticosteroid
    Neutrophil = 1,000/mm3
    Platelets = 100,000/mm3
    Hb = 10g/dL
    Total bilirubin = ULN; or total bilirubin = 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert’s Syndrome.
    AST or ALT = 3 × institutional ULN (=5 x ULN if liver metastases are present).
    Creatinine within normal institutional limits or creatinine clearance = 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
    LVEF > 50%
    ICF ottenuto prima di qualunque valutazione e procedura specifiche per lo studio
    Età =18 anni
    Ca mammario invasivo istologicamente confermato e non suscettibile di resezione o radioterapia con intento curativo.
    Ca mammario M+ HER2+ e RE + e/o RP+.
    E’ obbligatorio un campione FFPE tumorale,o di almeno 15 vetrini con positività per HER2 e recettori ormonali
    ECOG performance status 0-1
    I pazienti devono essere in grado e disposti ad assumere e trattenere farmaci per via orale, senza comorbidità che potrebbero interferire con l'assorbimento intestinale
    Nelle donne in età fertile,test di gravidanza neg entro 7 gg dalla random.Le donne in età fertile e pazienti di sesso maschile devono usare adeguati metodi contraccettivi per la durata del trattamento di protocollo e per 6 mesi dopo l'ultimo trattamento con palbociclib.
    Risoluzione di tutte le reazioni avverse acute del precedente regime CT di induzione associato a terapia anti-HER2 a G=1 secondo la classificazione NCI CTCAE v4.0
    Pazienti disponibili e capaci di rispettare quanto richiesto dal protocollo
    I pazienti possono aver o non aver ricevuto una terapia neo/adiuvante,ma devono avere un intervallo libero da malattia dal completamento della terapia anti-HER2 alla documentazione di metastasi = 6 mesi
    I pazienti devono aver ricevuto una terapia accettabile e standard con CT e terapia anti-HER2 di induzione per il trattamento del ca mammario metastatico La scelta del regime CT è limitata ad un taxano o vinorelbina (solo per regime con trastuzumab).I pazienti eleggibili devono avere completato 6 cicli di CT contenente trattamento anti-HER2. Un minimo di 4 cicli di trattamento accettabile per pazienti con tossicità significativa associata al trattamento. Il numero massimo di cicli è 8.Questi pazienti sono eleggibili a condizione che siano senza evidenza di progressione di malattia alla valutazione locale (cioè CR,PR o SD).
    I pazienti con anamnesi di metastasi al SNC trattate sono eleggibili se: Sono presenti segni di malattia al di fuori del SNC;Nessuna evidenza di progressione tra il completamento del trattamento per SNC e gli esami radiologici di screening;Nessuna anamnesi di emorragia intracranica o al midollo spinale;Non necessitano di terapia anticonvulsivante;Devono essere trascorse almeno 3 settimane tra il completamento della radioterapia al SNC e il g1c1,non devono essere presenti eventi avversi acuti significativi (G = 3) e non deve esserci necessità di somministrazione continuativa di corticosteroidi
    Neutrofili = 1.000/mm3
    Piastrine = 100.000/mm3
    Hb = 10g/dL
    Bilirubina totale = ULN; o bilirubina totale = 3,0 × ULN con bilirubina diretta entro i limiti di normalità per pazienti con documentata sindrome di Gilbert
    AST e ALT = 1,5 × ULN.
    Creatinina entro i limiti di normalità o creatinina clearance = 60 mL/min/1,73 m2 per I pazienti con creatinina superiore ai limiti di normalità.
    LVEF > 50%
    E.4Principal exclusion criteria
    Randomization
    1. Concurrent therapy with other Investigational Products.
    2. Prior therapy with any CDK 4/6 inhibitor.
    3. History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
    4. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for list of strong inhibitors or inducers of CYP3A isoenzymes).
    5. Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation.
    6. Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry.
    7. Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib.
    8. QTc interval >480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.
    9. Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis
    Randomizazione
    1. Concomitante trattamento con altri farmaci sperimentali
    2. Pregressa terapia con qualsiasi inibitore CDK
    3. Anamnesi di reazioni allergiche attribuite a composti di composizione chimica o biologica simile a palbociclib
    4. Pazienti in trattamento con farmaci o sostanze che sono potenti inibitori o induttori degli isoenzimi CYP3A entro 7 giorni dalla randomizzazione
    5. Altre malattie o condizioni mediche non controllate incluse, ma non limitate a, infezione in corso o attiva, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca, diabete, o malattie psichiatriche/situazioni sociali che limiterebbero la conformità ai requisiti di studio. La capacità di soddisfare i requisiti per la partecipazione allo studio deve essere valutata da ciascun ricercatore al momento dello screening
    6. Donne in gravidanza o donne fertili senza di un test di gravidanza (sierico o esame delle urine) negativo entro 7 giorni prima della randomizzazione, indipendentemente dal metodo di contraccezione impiegato, sono escluse dallo studio perché l'effetto di palbociclib su un feto in via di sviluppo è sconosciuto. L'allattamento al seno deve essere interrotto prima dell'ingresso nello studio.
    7. I pazienti in terapia antiretrovirale di combinazione, cioè coloro che sono HIV-positivi, non sono eleggibili a causa delle potenziali di interazioni farmacocinetiche o aumento della immunosopressione con palbociclib
    8. QTc> 480 msec, sindrome di Brugada o anamnesi di prolungamento dell'intervallo QTc, o torsioni di punta (TdP)
    9. Pazienti con anamnesi clinicamente significativa di malattie del fegato, inclusa l'epatite virale o altra malattia epatica nota, abuso di alcool attuale o cirrosi
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) as assessed by the Investigator
    Progressione libera da malattia (PFS) valutata dal ricercatore
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    1. Overall Survival (OS)
    2. 3-year and 5-year survival probabilities
    3. Objective response (OR: CR or PR)
    4. Duration of response (DOR)
    5. Clinical Benefit Rate (CBR: CR or PR or SD = 24 weeks)
    6. Safety: Type, incidence, severity (as graded by the NCI CTCAE v. 4.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities
    7. Patient Reported Outcomes: Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status
    1. Sopravvivenza globale (OS)
    2. Probabilità di sopravvivenza a 3 e 5 anni
    3. Risposta clinica obiettiva (OR: CR e PR)
    4. Durata della risposta (DOR)
    5. Beneficio clinico (CBR: CR o PR o SD = 24 settimane)
    6. Sicurezza: Tipo, incidenza, intensità (secondo NCI CTCAE v 4.0.), gravità e attribuzione ai farmaci in studio di eventi avversi ed eventuali anormalità di laboratorio
    7. Esiti riferiti dai pazienti (PRO): tempo al manifestarsi dei sintomi di progressione di malattia (FACT-B PFB-TOI), qualità di vita specifica per carcinoma mammario (HRQOL) e per lo stato di salute in generale
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    New Zealand
    United States
    France
    Germany
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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 years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months6
    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: 340
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 496
    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)
    none
    nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Fondazione Michelangelo
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA