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    The EU Clinical Trials Register currently displays   32596   clinical trials with a EudraCT protocol, of which   5272   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-002625-31
    Sponsor's Protocol Code Number:EORTC10041-GOIRC01/2007
    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:2008-01-03
    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 number2005-002625-31
    A.3Full title of the trial
    MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy): A prospective, randomized study comparing the 70-gene signature with the common clinical pathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes.
    MINDACT (Microarray In Node-negative and 1 to 3 positive lymph Disease May Avoid ChemoTherapy). STUDIO PROSPETTICO RANDOMIZZATO DI CONFRONTO FRA IL PROFILO DI ESPRESSIONE “AMSTERDAM” DI 70 GENI (“FIRMA” DI 70 GENI) E I CRITERI CLINICO-PATOLOGICI STANDARD, AL FINE DI SELEZIONARE PER CHEMIOTERAPIA ADIUVANTE, LE PAZIENTI AFFETTE DA CARCINOMA MAMMARIO CON 0-3 LINFONODI POSITIVI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, randomized study comparing the 70-gene signature with the common clinical pathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes
    STUDIO PROSPETTICO RANDOMIZZATO DI CONFRONTO FRA IL PROFILO DI ESPRESSIONE “AMSTERDAM” DI 70 GENI (“FIRMA” DI 70 GENI) E I CRITERI CLINICO-PATOLOGICI STANDARD, AL FINE DI SELEZIONARE PER CHEMIOTERAPIA ADIUVANTE, LE PAZIENTI AFFETTE DA CARCINOMA MAMMARIO CON 0-3 LINFONODI POSITIVI
    A.3.2Name or abbreviated title of the trial where available
    MINDACT
    MINDACT
    A.4.1Sponsor's protocol code numberEORTC10041-GOIRC01/2007
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN18543567
    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 SponsorEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.1.3.4CountryBelgium
    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 supportcomunita` europea
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointBreast Headquarters
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Mounier 83/11
    B.5.3.2Town/ cityBruxelles
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741062
    B.5.5Fax number+3227741030
    B.5.6E-mailmindact@eortc.be
    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 FEMARA*30CPR RIV 2,5MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    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 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 INNLetrozole
    D.3.9.1CAS number 112809-51-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typenon-steroidal aromatase inhibitor
    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 XELODA*60CPR RIV 150MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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 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 INNCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number1650
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 TAXOTERE*INFUS FL 80MG/2ML+F
    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 Powder and solvent for solution for 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 INNDocetaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeanti-micotic chemotherapy medication
    D.IMP: 4
    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 XELODA*120CPR RIV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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 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 INNCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number1650
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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 INNTamoxifen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeANTAGONIST OF THE ESTROGEN RECEPTOR IN BREAST TISSUE
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNDoxorubicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number2
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNEpirubicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number2
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 8
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for 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 INNCyclophosphamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 9
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for 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 INNFluorouracil
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number50
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    breast cancer patients
    pazienti con carcinoma mammario
    E.1.1.1Medical condition in easily understood language
    patients with breast cancer
    pazienti affette da tumore mammario
    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 10057654
    E.1.2Term Breast cancer female
    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
    1. The primary objective of the MINDACT trial is to demonstrate the superiority of the molecular profiling approach over the usual clinical assessment in assigning adequate risk categories (and the need to receive adjuvant chemotherapy or not) to breast cancer patients with 0 to 3 positive lymph nodes. 2. The trial will also aim to compare a docetaxel-capecitabine regimen possibly associated with increased efficacy and reduced long-term toxicities to existing commonly used anthracycline-based chemotherapy regimens (anthracyclines followed by docetaxel for node positive). 3. The last primary objective will be to determine the best endocrine treatment strategy i.e. single agent up-front, aromatase inhibitor (AI) (letrozole) for seven years compared to the sequential endocrine strategy of 2 years of tamoxifen followed by 5 years of letrozole.
    1. The primary objective of the MINDACT trial is to demonstrate the superiority of the molecular profiling approach over the usual clinical assessment in assigning adequate risk categories (and the need to receive adjuvant chemotherapy or not) to breast cancer patients with 0 to 3 positive lymph nodes. 2. The trial will also aim to compare a docetaxel-capecitabine regimen possibly associated with increased efficacy and reduced long-term toxicities to existing commonly used anthracycline-based chemotherapy regimens (anthracyclines followed by docetaxel for node positive). 3. The last primary objective will be to determine the best endocrine treatment strategy i.e. single agent up-front, aromatase inhibitor (AI) (letrozole) for seven years compared to the sequential endocrine strategy of 2 years of tamoxifen followed by 5 years of letrozole.
    E.2.2Secondary objectives of the trial
    Estimation of disease free survival, distant metastasis free survival, overall survival of chemotherapy in the groups where the prognostic methods are discordant. Calculation of overall estimates of efficacy for each treatment strategy according to the prognostic methods. Estimation of the % of patients receiving chemotherapy per each prognostic method. To identify and/or validate predictive gene expression profiles of clinical response/resistance to anthracycline and docetaxel`ˆ'capecitabine chemotherapy, and novel gene expression signatures predicting clinical response to sequential tamoxifen`ˆ'AI versus AI alone. To compare the OS distributions associated with the 2 chemotherapy arms. To determine and compare early and late toxicities associated with each arm. To evaluate adjuvant endocrine treatment success or failure in the group of postmenopausal patients with endocrine responsive disease. To compare the safety profile of the two endocrine therapy regimens
    Estimation of disease free survival,distant metastasis free survival,overall survival of chemotherapy in the groups where the prognostic methods are discordant Calculation of overall estimates of efficacy for each treatment strategy according to the prognostic methods Estimation of the % of patients receiving chemotherapy per each prognostic method To identify and/or validate predictive gene expression profiles of clinical response/resistance to anthracycline and docetaxel-capecitabine chemotherapy,and novel gene expression signatures predicting clinical response to sequential tamoxifen-AI versus AI alone To compare the OS distributions associated with the chemotherapy regimens To determine and compare early and late toxicities associated with each regimen To evaluate adjuvant endocrine treatment success or failure in the group of postmenopausal patients with endocrine responsive disease To compare the safety profile of the two endocrine therapy regimens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    women with histologically proven operable invasive breast cancer, with 0 to 3 positive lymph nodes and no distant metastases. acceptable treatment options are: ¨ breast conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance. ¨ radiotherapy is mandatory in the case of breast conserving surgery and will be administered according to local institutional policy after mastectomy. ¨ patients with unresectable positive deep margins who will receive adjuvant radiotherapy are eligible provided that all other margins are negative. ¨ with a clinical tumor classification of T1, T2 or operable T3. ¨ the breast tumor must be unilateral. Multi focal tumors are allowed provided that they have identical histology.DCIS or LCIS are allowed if invasive cancer is present. ¨ a frozen tumor sample (not fixed in formalin) must be available for inclusion. The tumor sample must be taken from the excised primary tumor (a core punch biopsy). ¨ patients should be aged ³ 18 years at randomization. ¨ have a WHO performance status of 0 or 1. ¨ have adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).
    • Donne con carcinoma della mammella confermato istologicamente, operabile, con 0-3 linfonodi positivi e assenza di metastasi a distanza. Opzioni di trattamento accettabili: o Chirurgia conservativa della mammella o mastectomia radicale con procedura per il linfonodo sentinella o linfadenectomia totale ascellare. o La radioterapia e' obbligatoria nel caso di chirurgia conservativa della mammella. Nel caso di mastectomia dovra' essere somministrata in accordo con le linee guida istituzionali locali. o Le pazienti con margini profondi positivi non resecabili che ricevono radioterapia sono eleggibili solo se gli altri margini sono negativi. • Classificazione del tumore T1, T2 o T3 operabile. • Il tumore della mammella deve essere unilaterale. Tumori multifocali sono accettati, ammesso che abbiano stesso tipo istologico. Sono comunque permessi tumori del tipo DCIS o LCIS in presenza di tumore invasivo. • Deve essere disponibile per l’inclusione un campione di tumore congelato (non fissato in formalina) . Il campione deve essere escisso dal tumore primario (biopsia del tipo “core punch”). • Eta': superiore o uguale a 18 anni alla randomizzazione. • Performance Status WHO di 0 o 1. • Per ricevere la chemioterapia, le pazienti devono avere un`adeguata riserva midollare (conta neutrofili &gt;1.5x109/l e conta delle piastrine &gt;100x109/l), adeguata funzionalita' renale (creatinina sierica ≤1.5xUNL), adeguata funzionalita' epatica (ALAT e ASAT≤2.5x UNL, fosfatasi alcalina ≤2.5 UNL, bilirubina totale ≤ 2x UNL)
    E.4Principal exclusion criteria
    have NO serious cardiac illness or medical condition including but not confined to: a history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring antianginal medication, clinically significant valvular heart disease, evidence of transmural infarction on ECG, poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg), symptomatic coronary artery disease or a myocardial infarction within the last 12 months or other risk factors that contra-indicate the use of anthracycline-based chemotherapy. ¨ NOT have serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease. ¨ NOT have previous or concurrent cancer, possible exceptions are: adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, lobular or ductal carcinoma in situ of the breast and any invasive cancer (other than breast cancer) in complete remission for ≥ 5 years. ¨ NOT have received (neo) adjuvant chemotherapy, (neo) adjuvant endocrine therapy or radiotherapy for the primary breast cancer considered for this trial. ¨ NOT have participated in any investigational drug study within the 4 weeks preceding the start of treatment. ¨ NOT be pregnant or breast-feeding at the time of diagnosis or randomization. A woman of childbearing potential must have a negative pregnancy test. If post-menopausal, the woman must have been amenorrheic for at lest 12 months to be considered of non-childbearing potential while taking study medications patients should take adequate birth control measures which result in low failure rates (i.e. less then 1% per year) when used consistently and correctly such as implants, some IUDs, condoms, sexual abstinence or vasectomised partner (Note 3 of the guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals CPMP/ICH/286/95). ¨ NOT have any psychological, familial, sociological, geographical or serious uncontrolled medical (e.g. a history of uncontrolled seizures, central nervous system disorders, or psychiatric disability) condition judged by the investigator to be clinically significant which could potentially preclude informed consent or interfere with compliance for oral drug intake or with the study protocol and follow-up schedule. These conditions should be discussed with the patient before enrollment in the trial.
    • Le pazienti non devono avere infezioni ricorrenti non controllate o altre malattie concomitanti non controllate. • Assenza di altri tumori precedenti o concomitanti ad eccezione di: carcinoma in situ della cervice adeguatamente trattato, tumore della pelle diverso dal melanoma, carcinoma in situ della mammella lobulare o duttale e qualunque altro tipo di tumore invasivo (diverso dal tumore della mammella) in remissione completa da piu' di 5 anni. • Le pazienti non devono avere ricevuto chemioterapia (neo)adiuvante, endocrino terapia (neo)adiuvante o radioterapia per il carcinoma primario della mammella considerato in questo studio. • Le pazienti non devono aver partecipato ad altri studi clinici di ricerca entro le 4 settimane precedenti all’inizio del trattamento. • Le pazienti non devono essere in gravidanza o in allattamento al momento della diagnosi o della randomizzazione. Le donne in eta' fertile devono avere un test di gravidanza negativo. Se in post-menopausa , le pazienti devono essere amenorroiche da almeno 12 mesi per essere considerate non fertili. • Durante lo studio le pazienti devono utilizzare adeguate misure di contraccezione che comportano un basso tasso di fallimento (cioe' &lt;1% all’anno) se usate regolarmente e correttamente come ad esempio contraccettivi iniettabili, impianti, alcuni dispositivi intrauterini, preservativi, astinenza sessuale o vasectomia del partner (Nota 3 della Guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals. (CPMP/ICH/286/95). • Le pazienti non devono avere condizioni psicologiche, familiari, sociologiche o geografiche o condizioni cliniche gravi non controllate (per esempio storia di epilessia non controllata, disordini del sistema nervoso centrale o disabilita' psichiatrica non controllati) ritenute clinicamente significative dallo sperimentatore e che potrebbero potenzialmente precludere l’ottenimento del consenso informato o interferire con la compliance per la somministrazione orale dei farmaci o impedire la compliance al protocollo di studio o al follow up. Queste condizioni dovrebbero essere discusse con la paziente prima della registrazione in studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the MINDACT trial is to demonstrate the superiority of the molecular profiling approach over the usual clinical assessment in assigning adequate risk categories (and the need to receive adjuvant chemotherapy or not) to breast cancer patients with 0 to 3 positive lymph nodes. 2. The trial will also aim to compare a docetaxel-capecitabine regimen possibly associated with increased efficacy and reduced long-term toxicities to existing commonly used anthracycline-based chemotherapy regimens (anthracyclines followed by docetaxel for node positive). 3. The last primary objective will be to determine the best endocrine treatment strategy i.e. single agent up-front, aromatase inhibitor (AI) (letrozole) for seven years compared to the sequential endocrine strategy of 2 years of tamoxifen followed by 5 years of letrozole.
    1. L’obiettivo primario dello studio Mindact e' dimostrare la superiorita' di un approccio basato sul profilo molecolare rispetto alla valutazione clinica usuale nell’assegnare categorie di rischio adeguate (e la necessita' di ricevere chemioterapia adiuvante o no) a pazienti affette da tumore della mammella con 0-3 linfonodi positivi. 2. Lo studio ha anche lo scopo di confrontare un regime chemioterapico a base di docetaxel-capecitabina, possibilmente associato con un aumento di efficacia e una ridotta tossicita' a lungo termine, rispetto al regime standard di chemioterapia a base di antraci cline (antraci cline seguite da docetaxel per le pazienti con linfonodi positivi). 3. Determinare la migliore strategia di terapia endocrina cioe' una monoterapia con agente singolo sin dall`inizio, inibitore delle aromatasi (AI) (letrozolo) per sette anni, comparato con uno schema sequenziale di terapia endocrina di 2 anni di tamoxifene seguiti da 5 anni di letrozolo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not available
    non disponibile
    E.5.2Secondary end point(s)
    Comparison of the two prognostic methods: ¨ To estimate both relative (Hazard Ratio, HR) and absolute (as % at 5 years) efficacy in terms of disease free survival (DFS), distant metastasis free survival (DMFS) and overall survival (OS) of chemotherapy in the two subgroups where the clinical-pathological prognosis and the 70-gene signature molecular prognosis are discordant. ¨ To calculate overall estimates of efficacy (DFS, DMFS, OS) for each treatment strategy according to clinical-pathological prognosis and according to molecular prognosis. ¨ To estimate the percentage of patients receiving chemotherapy per each prognostic method. Gene profiling: ¨ To identify and/or validate predictive gene expression profiles of clinical response/resistance to anthracycline-based and docetaxelcapecitabine chemotherapy. ¨ The identification and validation of novel gene expression signatures predicting clinical response to sequential tamoxifen-AI versus AI alone. Chemotherapy: ¨ To compare the OS distributions associated with the 2 chemotherapy arms ¨ To determine and compare the early and late toxicities associated with each arm. Endocrine therapy: ¨ To evaluate adjuvant endocrine treatment success or failure in the subgroup of postmenopausal patients with endocrine responsive disease. ¨ To compare the safety profile of the two endocrine therapy regimens
    Confronto di due modelli prognostici: • Stimare sia l’efficacia relativa (Hazard Ratio, HR), che assoluta (come % a 5 anni) in termini di sopravvivenza libera da malattia (DFS, Disease Free Survival), di sopravvivenza libera da metastasi a distanza (DMFS, Distant Metastasis Free Survival) e di sopravvivenza complessiva (OS, Overall Survival) della chemioterapia nei due sottogruppi in cui la prognosi clinico-patologica e la prognosi molecolare determinata con la “firma” di 70 geni sono discordanti. • Calcolare la stima complessiva dell’efficacia (DFS, DMFS, OS) per ogni strategia di trattamento secondo la prognosi clinico-patologica e secondo la prognosi molecolare. • Stimare la percentuale di pazienti che ricevono la chemioterapia per ciascun metodo prognostico. Profilo genico: 1. Identificare e/o validare il profilo di espressione genica predittivo della risposta clinica/resistenza alla chemioterapia basata sull’impiego di antracicline e sull’impiego di docetaxel-capecitabina. 2. Identificazione e validazione di una nuova `firma` dell’espressione genica che sia predittiva della risposta clinica per lo schema sequenziale Tamoxifene-AI vs solo AI. Chemioterapia: 1. Confrontare le distribuzioni di OS associate con i due bracci chemioterapici. 2. Determinare e confrontare le tossicita' precoci e tardive associate ad ogni braccio. Terapia Endocrina: 1. Valutare il successo o il fallimento del trattamento endocrino nel sottogruppo di pazienti in post-menopausa con malattia endocrino–responsiva. 2. Confrontare il profilo di sicurezza dei due regimi di terapia endocrina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    not available
    non disponibile
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy 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.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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    metodologia per prognosi
    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 concerned20
    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 years17
    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 years17
    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.1.1Number 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) Yes
    F.1.2.1Number of subjects for this age range: 6000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-01-03. Yes
    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 state5830
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5830
    F.4.2.2In the whole clinical trial 6600
    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)
    not available
    non disponibile
    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 Decision2008-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
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