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    Summary
    EudraCT Number:2014-005181-30
    Sponsor's Protocol Code Number:ABCSG-42
    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:2021-01-28
    Trial results View 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 number2014-005181-30
    A.3Full title of the trial
    PALbociclib CoLlaborative Adjuvant Study:
    A randomized phase III trial of Palbociclib with standard adjuvant
    endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer
    Studio di fase III, randomizzato, teso a valutare palbociclib in combinazione con la terapia endocrina adiuvante standard rispetto alla terapia endocrina adiuvante standard in monoterapia per il trattamento del carcinoma mammario in fase iniziale negativo per il recettore del fattore di crescita epidermico umano 2 (HER2-)/positivo per i recettori ormonali (HR+)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PALbociclib CoLlaborative Adjuvant Study:
    A randomized phase III trial of Palbociclib with standard adjuvant
    endocrine therapy versus standard adjuvant endocrine therapy alone for
    hormone receptor positive/HER2-negative early breast cancer
    Studio di fase III, randomizzato, teso a valutare palbociclib in combinazione con la terapia endocrina adiuvante standard rispetto alla terapia endocrina adiuvante standard in monoterapia per il trattamento del carcinoma mammario in fase iniziale negativo per il recettore del fattore di crescita epidermico umano e positivo per i recettori ormonali
    A.3.2Name or abbreviated title of the trial where available
    PALLAS
    PALLAS
    A.4.1Sponsor's protocol code numberABCSG-42
    A.5.4Other Identifiers
    Name:IND Number:126003
    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 SponsorABCSG GMBH
    B.1.3.4CountryAustria
    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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABCSG
    B.5.2Functional name of contact pointTrial Office (Studienzentrale)
    B.5.3 Address:
    B.5.3.1Street AddressNussdorfer Platz 8
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1190
    B.5.3.4CountryAustria
    B.5.4Telephone number004314089230
    B.5.5Fax number004314090990
    B.5.6E-mailinfo@abcsg.at
    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 No
    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 namePalbociclib
    D.3.2Product code [PD-0332991-00]
    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.3.8INN - Proposed INNPalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB34094
    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 No
    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 namePalbociclib
    D.3.2Product code [PD-0332991-00]
    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.3.8INN - Proposed INNPalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB34094
    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.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 No
    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 namePalbociclib
    D.3.2Product code [PD-0332991-00]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.4EV Substance CodeSUB34094
    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
    To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
    Determinare se l'aggiunta di palbociclib alla terapia endocrina adiuvante migliorerà l'esito rispetto alla terapia endocrina da sola per tumori al seno precoci HR+/HER2
    E.1.1.1Medical condition in easily understood language
    To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer.
    Determinare se l'aggiunta di palbociclib alla terapia endocrina adiuvante migliorerà l'esito rispetto alla terapia endocrina da sola per tumori al seno precoci HR+/HER2
    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 LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive 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 compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC).
    Confrontare la sopravvivenza libera da malattia invasiva (iDFS) per la combinazione di terapia endocrina per almeno 5 anni e trattamento con palbociclib per 2 anni rispetto alla terapia endocrina in monoterapia per almeno 5 anni in pazienti affette da carcinoma mammario invasivo in fase iniziale (EBC) HR+/HER2- confermato istologicamente.
    E.2.2Secondary objectives of the trial
    To compare the following endpoints: iDFS excluding second primary invasive cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS).
    To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.
    Confrontare i seguenti endpoint: iDFS, esclusi i secondi tumori primari invasivi non di origine mammaria, la sopravvivenza libera da recidiva distante (DRFS), la sopravvivenza libera da recidiva locoregionale (LRRFS) e la sopravvivenza totale (OS).
    Confrontare la sicurezza a 2 anni di palbociclib in combinazione con la terapia endocrina adiuvante rispetto alla terapia endocrina adiuvante in monoterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-signed Informed consent(2)Age =18 ys. (3)Pre and postmenopausal women or men with Stage II (Stage IIA limited to a max. of 1000 patients) or Stage III early invasive breast cancer per AJCC Breast Cancer Staging version 7 /UICC.(4) Pts with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2. (5)Pts must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer. ER, PR and HER2 measurement in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP guidelines. Pts with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are eligible, as long as they have not received and are not scheduled to receive anti-HER2 treatment. Testing may occur on diagnostic core or surgical tumor tissue.(6)Pts must have undergone breast surgery for the current malignancy.7)A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be transmitted to a central sample repository and confirmation of receipt must be available prior to randomization.(8) ECOG performance status 0-1.(9)Pts able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.(10) Serum or urine pregnancy test negative within 7 days of randomization. Pregnancy testing does not need to be pursued in pts who are judged as postmenopausal before randomization, or who undergone bilateral ophorectomy, total hysterectomy, or bilateral tubal ligation. Women of childbearing potential and male pts randomized into treatment Arm A or B must use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib if they are in arm A. Pts receiving standard adjuvant endocrine therapy (Arm A and Arm B) should use adequate contraception in accordance with the specific medication requirements.(11)Pts may or may not have received neo/adjuvant therapy, but must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects at randomization.(12)Patients may or not have received breast/axilla/postmastectomy chest wall radiotherapy, but must be after last dose of radiotherapy and must have sufficient resolution of side effects at randomization.(13)Patients must have sufficient resolution of any surgical side effects from the last surgery at the randomization.(14)Patients must either be initiating or have already started adjuvant hormonal treatment. Patients may already have initiated endocrine therapy at the time of randomization, but randomization must take place within 12 months of date of histological diagnosis and within 6 months of initiating standard adjuvant endocrine therapy. Pts who received neoadjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy. Patients may be receiving tamoxifen or aromatase inhibitor. For premenopausal and men, concurrent LHRH agonist use allowable and be ongoing at randomization. If a LHRH agonist used for ovarian protection during neo/adjuvant chemotherapy it is allowable and shall not be taken into account x calculations reg the 6 months standard adjuvant endocrine therapy.Baseline Body Function Specifics(15)Absolute neutrophil count=1,500/mm3(16)Platelets=100,000/mm3 (17) Hemoglobin=10g/dL.(18)Total serum bilirubin=ULN; or total bilirubin=3.0×ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome. (19)AST or SGOT and alanine ALT or SGP=1.5xULN.(20)Serum creatinine below ULN or creatinine clearance or GFR= 60mL/min/1.73m2 x pts with serum creatinine levels above ULN.
    (1) Consenso informato firmato(2) Età =18(3) Donne in pre epostmenopausa o uomini con carcinoma mammario invasivo in fase iniziale di stadio II o stadio III x classificazione AJCC per stadiazione carcinoma mammario versione 7 /UICC. Non è necessaria la stadiazione iniziale per documentare assenza di malattia metastatica(4) Pazienti con carcinoma mammario invasivo multicentrico e/o multifocale e/o bilaterale in fase iniziale, di cui i tumori soddisfano i criteri patologici per ER+ e/o PR+ e HER2-. (5) Pazienti affetti da carcinoma mammario invasivo in fase iniziale positivo per recettori ormonali (ER+ e/o PR+) e negativo per HER2 (HER2-). Misurazioni ER, PR e HER2 secondo le linee guida CLIA in USA o in laboratori certificati non USA. I valori dei limiti per la colorazione positiva/negativa conformi alle linee guida ASCO/CAP. Pazienti con risultati equivoci x HER2 a ibridazione in situ secondo le linee ASCO/CAP sono idonei , se non hanno ricevuto e non sia pianificato un trattamento anti-HER2. L'esame eseguito su tessuto tumorale chirurgico o diagnostico.(6) Pazienti sottoposti a intervento chirurgico a mammella per il tumore corrente. (7) Un blocco di tessuto tumorale fissato in formalina e incluso in paraffina (FFPE) inviato a banca centrale per conservazione dei campioni e disponibile conferma della ricezione prima della randomizzazione.8) Stato di validità ECOG 0-1.(9) Pazienti in grado di deglutire e trattenere il medicinale orale in assenza di condizioni che possano interferire con l'assorbimento enterico. (10) Test di gravidanza su siero o urina negativo nei 7 giorni precedenti la randomizzazione. Donne in età fertile e i pazienti maschi randomizzati al braccio A o B dovranno usare metodo contraccettivo adeguato per la durata del trattamento e per 6 mesi successivi all'ultimo trattamento con palbociclib, se sono nel braccio A. Pazienti che ricevono trattamento endocrino adiuvante (A e B) dovrebbbero usare un metodo contracettivo idoneo in accordo alle informazioni sul prodotto itlizzato (es RCP)ISpecifiche del trattamento precedente (11) sottoposti o no a terapia adiuvante/neoadiuvante, ma ultima dose di chemioterapia e/o terapia biologica e, secondo il giudizio del medico, devono aver risolto gli effetti collaterali alla randomizzazione.(12) Sottoposti o meno a radioterapia postmastectomia sulla parete toracica /ascella/mammella, ma già fatta ultima dose di radio e devono aver risolto gli effetti collaterali alla randomizzazione.(13) Risolto qualsiasi effetto collaterale dovuto all'ultimo intervento chirurgico senza complicanze attive relative a guarigione ferite alla andomizzazione (14) I pazienti devono stare per iniziare o avere già iniziato un trattamento ormonale adiuvante. I pazienti possono avere già iniziato la terapia endocrina alla randomizzazione, ma randomizzazione entro 12 mesi dalla data diagnosi istologica ed entro 6 mesi da inizio terapia endocrina adiuvante std. Pazienti che hanno ricevuto terapia endocrina neoadiuvante idonei a partecipare, se arruolati entro 12 mesi dalla diagnosi iniziale e dopo completamento di non più di 6 mesi di terapia endocrina adiuvante. Concesso tamoxifene o un inibitore dell'aromatasi. Se si usa agonista LHRH x protezione delle ovaie durante chemioterapia neo / adiuvante è ammissibile e non deve essere preso in considerazione per i calcoli relativi alla terapia endocrina adiuvante std da 6 mesi.(15) Conta assoluta dei neutrofili=1.500/mm3(16) Piastrine=100.000/mm3(17) HB=10 g/dl(18) Bilirubina sierica totale=ULN; o bilirubina totale=3,0×ULN con bilirubina diretta entro l'intervallo di normalità in pazienti con sindrome di Gilbert documentata.(19) AST o SGOT e ALT o SGPT)=1,5×ULN .(20) Creatinina sierica ULN o clearance creatinina (o grado filtrazione glomerulare [GFR])= 60 ml/min/1,73 m2 pazienti con livelli di creatinina sierica al di sopra di ULN
    E.4Principal exclusion criteria
    (1) Concurrent therapy with other Investigational Products.
    (2) Prior therapy with any CDK inhibitor.
    (3) Patients with Stage I or IV breast cancer are not eligible. Baseline staging to document absence of metastatic disease is not required, however is recommended as determined by institutional practice.
    (4) History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
    (5) Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization.
    (6) Uncontrolled intercurrent 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.
    (7) 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.
    (8) Patients with a history of any malignancy are ineligible except for the following circumstances:
    • Patients with a malignancy history other than invasive breast cancer are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
    • Patients with the following cancers are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic non-melanomatous skin cancer.
    (9) Patients are not eligible if they have previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy. This includes use for prophylactic reasons, including treatment of osteoporosis or cancer prevention with tamoxifen, raloxifene or AI.
    Patients may concurrently receive bisphosphonates or rank ligand inhibitors while on this study if necessary for treatment or prevention of osteopenia or osteoporosis. (10) 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.
    (11) Patients with clinically significant chronic history of liver disease, including chronic/active viral or other known hepatitis, current alcohol abuse, or cirrhosis, etc.
    (12) Patients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil, etc.) are not eligible but topical vaginal estrogen therapy is allowable.
    (1) Terapia concomitante con farmaci sperimentali.
    (2) Terapia pregressa con un inibitore della chinasi ciclina-dipendente (CDK).
    (3) Non sono idonei i pazienti con carcinoma mammario di stadio I o IV. Non è necessaria la stadiazione iniziale per documentare l'assenza di malattia metastatica, tuttavia è raccomandata quando stabilito dalla pratica istituzionale (in pazienti per i quali esiste un ragionevole sospetto di malattia avanzata, per es., tumori di grandi dimensioni, linfonodi ascellari, segni e sintomi clinicamente positivi). Se questi esami sono stati eseguiti, devono essere disponibili i rispettivi referti. Il tipo di esame per stabilire la stadiazione, cioè radiografia, sonografia, densitometria ossea, TC, RM e/o PET-TC, è a discrezione dello sperimentatore.
    (4) Anamnesi di reazioni allergiche attribuite a composti con composizione chimica o biologica simile a palbociclib. (5) Pazienti che ricevono un medicinale o una sostanza che è un forte inibitore o induttore degli isoenzimi CYP3A nei 7 giorni che precedono la randomizzazione (vedere la sezione 9.5.2.1 del protocollo per l'elenco degli inibitori e degli induttori di CYP3A).
    (6) Malattia concomitante non controllata, compresi a titolo esemplificativo ma non esaustivo infezione in corso o attiva, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca, diabete o malattia psichica/situazione sociale che limiterebbe la compliance con i requisiti dello studio. La capacità di seguire i requisiti dello studio deve essere valutata da ogni sperimentatore al momento dello screening per la partecipazione allo studio.
    (7) Sono escluse da questo studio le donne in gravidanza o in età fertile senza un test di gravidanza negativo (su siero o urina) eseguito nei 7 giorni che precedono la randomizzazione, indipendentemente dall'utilizzo del metodo contraccettivo, poiché non è noto l'effetto di palbociclib sul feto. L'allattamento al seno deve essere interrotto prima dell'ingresso nello studio.
    (8) Non sono idonei a partecipare allo studio i pazienti con una anamnesi tumore, fatta eccezione per le seguenti circostanze:
    ¿ I pazienti con una anamnesi di tumore diverso dal carcinoma mammario invasivo sono idonei, se sono liberi da malattia da almeno 5 anni e, secondo il giudizio dello sperimentatore, sono a basso rischio di recidiva del tumore.
    ¿ Sono idonei a partecipare allo studio i pazienti affetti dai seguenti tumori, anche se diagnosticati e trattati negli ultimi 5 anni: carcinoma duttale in situ della mammella, carcinoma della cervice in situ e tumori della cute non melanomatosi, non metastatici.
    (9) Non sono idonei i pazienti che hanno ricevuto una terapia endocrina nei 5 anni precedenti alla diagnosi del tumore attuale. Ciò comprende l'utilizzo per ragioni di profilassi, tra cui il trattamento dell'osteoporosi o la prevenzione tumorale con tamoxifene, raloxifene o AI. Mentre partecipano allo studio, i pazienti possono ricevere in concomitanza bifosfonati o inibitori del Rank-ligando, se necessario per il trattamento o la prevenzione di osteopenia o osteoporosi.
    (10) Non sono idonei a partecipare allo studio pazienti sottoposti a con terapia antiretrovirale di combinazione, cioè i pazienti HIV-positivi, per le possibili interazioni farmacocinetiche o la maggiore immunosoppressione associata all'uso di palbociclib.
    (11) Pazienti con anamnesi clinicamente significativa di epatopatia cronica, incluse epatiti croniche/attivedi origine virale o di altro tipo, abuso attuale di alcool o cirrosi, ecc.
    (12) Non sono idonei i pazienti sottoposti a terapia ormonale esogena concomitante (terapia ormonale sostitutiva, contraccettivi ormonali orali o di qualsiasi altro tipo, quale la spirale contraccettiva ormonale, ecc.), ma è consentita la terapia estrogenica vaginale.
    E.5 End points
    E.5.1Primary end point(s)
    Invasive disease-free survival (iDFS) defined acc. to STEEP criteria
    Sopravvivenza libera da malattia invasive (iDFS) definita accettabile dai criteri STEEP
    E.5.1.1Timepoint(s) of evaluation of this end point
    First interim analysis will take place after first 157 iDFS events have
    occured (33% of total number of iDFS events; estimated <3 years after
    FPI) and the second interim analysis after accrual is completed and 313
    iDFS events have occured (67% of total iDFS events; estimated <4 years
    after FPI). The final analysis of iDFS will occur when 469 iDFS events
    (100%) are observed.
    La prima analisi ad interim sarà condotta dopo I primi 157 eventi di iDFS (33% del numero totale di eventi iDVS); si stima <3 anni dopo il primo paziente arruolato) e la seconda analisi ad intermi si svolgerà dopo che l'arruolamento è completato e 313 eventi iDFS si sono verificati (67% degli eventi iDFS totali; si stima < 4 anni dopo il Primo Paziente arruolato. L'analisi finale di iDFS avverrà quando 469 eventi iDFS (100%) saranno osservati.
    E.5.2Secondary end point(s)
    (1) Invasive disease-free survival (iDFS) excl. second primary invesive cancers of non-breast origin as an event.
    (2) Overall Survival (OS)
    (3) Locoregional recurrences-free survival (LRRFS) defined as the
    composite of local/regional ipsilateral recurrence, contralateral invasive
    breast cancer or death from any cause
    (4) Distant recurrence free survival (DRFS) is defined acc. to STEEP
    criteria as the composite of distant recurrence or death from any cause.
    (5) Adverse Events
    (1) iDFS tranne secondi tumori invasivi primar di origine non-mammaria come un evento.
    (2) Sopravvivenza globale (OS)
    (3) Sopravvivenza priva di ricorrenza in loco/regionale (LRRFS) definita come composta da locale/regionale ricorrenza ipsilaterale, tumore al seno invasive contralaterale o morte per qualsiasi causa
    (4) sopravvivenza libera da ricorrenza distale (DRFS) definita secondo I criteri STEEP come composta da ricorrenza distale o morte per qualsiasi causa
    (5) Eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the first secondary endpoint, first interim analysis will take place
    after first 157 iDFS events have occured (33% of total number of iDFS
    events; estimated <3 years after FPI) and the second interim analysis
    after accrual is completed and 313 iDFS events have occured (67% of
    total iDFS events; estimated <4 years after FPI). The final analysis of
    iDFS will occur when 469 iDFS events (100%) are observed. All other secondary endpoints will be analyzed after the occurence of 469 iDFS events.
    Per il primo endopoint secondario, la prima analisi ad interim sarà condotta dopo I primi 157 eventi di iDFS (33% del numero totale di eventi iDVS; <3 anni dopo il primo paziente arruolato) e la seconda analisi ad intermi si svolgerà dopo che l'arruolamento è completato e 313 eventi iDFS si sono verificati (67% degli eventi iDFS totali; si stima < 4 anni dopo il Primo Paziente arruolato). L'analisi finale di iDFS avverrà quando 469 eventi iDFS (100%) saranno osservati.
    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 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 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA177
    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
    Canada
    Israel
    Japan
    Korea, Republic of
    Mexico
    Singapore
    Taiwan
    United States
    Austria
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    End of study is the date when the last patient has completed their end of study visit, all data have been collected, and all queries have been resolved.
    La conclusione dello studio è la data in cui l'ultimo paziente ha completato le visite dello studio, tutti I dati sono stati raccolti e tutte le query sono state risolte
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    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 years15
    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: 4480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1120
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2305
    F.4.2.2In the whole clinical trial 5600
    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 after care according to institutional guidellines
    Trattamento standard secondo le linee guida Istituzionali
    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 Breast International Group (BIG)
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation AFT (Alliance Foundation Trials)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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