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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004470-26
    Sponsor's Protocol Code Number:ICR-CTSU/2006/10003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2008-02-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-004470-26
    A.3Full title of the trial
    Triple Negative breast cancer Trial. A randomised phase III trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced ER-, PR- and HER2- breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced ER-, PR- and HER2- breast cancer
    A.3.2Name or abbreviated title of the trial where available
    TNT
    A.4.1Sponsor's protocol code numberICR-CTSU/2006/10003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN97330959
    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 SponsorThe Institute of Cancer Research
    B.1.3.4CountryUnited Kingdom
    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 supportCancer Research UK/Breakthrough Breast Cancer
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Andrew Tutt
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Oncology, 3rd Floor Bermondsey Wing, Guy's Hosiptal
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207188 9881
    B.5.5Fax number00440207188 9986
    B.5.6E-mailandrew.tutt@icr.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKings College London
    B.1.3.4CountryUnited Kingdom
    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 supportCancer Research UK/Breakthrough Breast Cancer
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Andrew Tutt
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Oncology, 3rd Floor Bermondsey Wing, Guy's Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207188 9881
    B.5.5Fax number00440207188 9986
    B.5.6E-mailandrew.tutt@icr.ac.uk
    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 Carboplatin 10mg/ml (150mg/15ml)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical 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 INNCARBOPLATIN
    D.3.9.1CAS number 41575944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.IMP: 2
    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.2.5The 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 nameDocetaxel
    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.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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 or recurrent locally advanced breast cancer that
    is ER-, PR- (or unknown) and HER2- or known BRCA1/BRCA
    2 carriers.
    E.1.1.1Medical condition in easily understood language
    metastatic or recurrent locally advanced breast cancer that
    is ER-, PR- (or unknown) and HER2- or known BRCA1/BRCA
    2 carriers.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective tumour response rate (CR + PR): Response will be evaluated after three and six cycles of chemotherapy using modified RECIST criteria (see Appendix 2), with appropriate clinical assessment and radiological investigations. There will be a ‘response evaluation committee’ to independently assess all claimed responses
    E.2.2Secondary objectives of the trial
    Time to progression (TTP): This will be defined according to RECIST criteria and will be
    measured from randomisation until the confirmation of progression.
    • Progression Free Survival (PFS): This will be defined according to RECIST criteria and will be measured from randomisation until the confirmation of progression or death.
    • Response to second line protocol therapy on progression will be assessed using RECIST criteria as described for the primary endpoint.
    Time to Treatment Failure (TTF): This will be defined as time from randomisation to
    discontinuation of protocol treatment for any reason, or progression of disease as defined by RECIST.
    • Overall Survival (OS): This will be defined as time from randomisation until death from any cause in the intention to treat population.
    • Toxicity: This will be assessed throughout the treatment period using the NCI CTC AE v3.0
    • Frequency of development of symptomatic new cerebral metastases
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Either:
    • Histologically confirmed ER-, PR-, HER2- primary invasive breast cancer
    Allred/quick score <3 or H score <10 or ER and PR negative, if other cut-offs used (e.g., 1%, 5% or
    10%), see Appendix 3. HER2 negative defined as immunohistochemistry scoring 0 or 1+ for
    HER2, or 2+ and non-amplified for HER2 gene by FISH or CISH; see Appendix 3.
    or:
    • PR unknown but ER- and HER2-, and otherwise eligible. Please arrange urgent PR
    testing. If PR unknown and PR testing is not possible within a reasonable timeframe,
    the patient is eligible for the trial provided that ER and HER2 status are negative and
    all other eligibility criteria are met.
    or:
    • Confirmed BRCA1 or 2 mutation carrier, with any ER, PR and HER2 status
    plus:
    • Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for
    local therapy but suitable for taxane chemotherapy.
    TNT Protocol Version 3.0, 18 June 2009
    10
    NB: Patients who have not received anthracycline based chemotherapy in the
    adjuvant setting or for locally advanced disease may have received a non-taxane,
    anthracycline regimen as their first treatment at relapse and are eligible to enter the
    trial at confirmed progression after the anthracycline treatment
    • Patients with stable, treated brain metastases will be eligible providing informed
    consent can be given and that other sites of measurable disease are present
    • Patients with bone metastases currently receiving bisphosphonates for palliation will
    be eligible providing other sites of measurable disease are present
    • ECOG Performance Status 0, 1 or 2 (see Appendix 4)
    • Adequate haematology, biochemical indices (FBC, U & Es)
    • LFTs = Normal bilirubin, AST and/or ALT ≤3 x ULN if Alk Phos >5 x ULN (or an
    isolated elevation AST/ALT of ≤5 x ULN)
    • Adequate renal function – Glomerular Filtration Rate (GFR) of >25mls per minute
    (see Appendix 5)
    • Written informed consent, able to comply with treatment and follow-up.
    E.4Principal exclusion criteria
    Original primary tumour or subsequent relapse known to be positive for any of ER,
    PR, or HER2 receptors (defined above and in Appendix 3) unless patient is a known
    BRCA1 or BRCA 2 mutation carrier
    • Patients unfit for chemotherapy or those with neuropathy >grade 1 (sensory or motor)
    • Known allergy to platinum compounds or to mannitol
    • Known sensitivity to taxanes
    • Patients with inoperable locally advanced disease suitable for local radiotherapy or an
    anthracycline containing regimen.
    • Previous chemotherapy for metastatic disease other than an anthracycline as in
    inclusion criteria above.
    • Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial
    entry
    • Previous treatment with a taxane for recurrent locally advanced disease which was
    not completely excised.
    • Previous treatment with a platinum chemotherapy drug
    • LFTs = Abnormal bilirubin (> ULN) and/or AST and/or ALT >3 x ULN with Alk Phos >5
    x ULN, or an isolated elevation AST/ALT of >5 x ULN.
    • Patients with a life expectancy of less than 3 months
    TNT Protocol Version 3.0, 18 June 2009
    11
    • Previous malignancies other than adequately treated in situ carcinoma of the uterine
    cervix or basal or squamous cell carcinoma of the skin, unless there has been a
    disease-free interval of at least 10 years
    • Previous or synchronous second breast cancer (unless also confirmed ER-, PR-
    /unknown and HER2-)
    • Patients with bone limited disease
    • Other serious uncontrolled medical conditions or concurrent medical illness likely to
    compromise life expectancy and/or the completion of trial therapy
    • Pregnant, lactating or potentially childbearing women not using adequate
    contraception
    (documentation of a negative serum HCG pregnancy test should be available for premenopausal
    women with intact reproductive organs, or women less than two years
    after the menopause. Fertile women and their partners must use a medically
    acceptable contraceptive throughout the treatment period and for six months following
    cessation of treatment. Subjects must be made aware before entering the trial of the
    risk in becoming pregnant).
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY ENDPOINT
    Objective tumour response rate (CR + PR): Response will be evaluated after three and six cycles of chemotherapy using modified RECIST criteria (see Appendix 2), with appropriate clinical assessment and radiological investigations. There will be a ‘response evaluation committee’ to independently assess all claimed responses.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Response will be evaluated after three and six cycles of chemotherapy using modified RECIST criteria (see Appendix 2 of protocol), with appropriate clinical assessment and radiological investigations. There will be a ‘response evaluation committee’ to independently assess all claimed responses.
    E.5.2Secondary end point(s)
    SECONDARY ENDPOINTS
    • Time to progression (TTP): This will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression.

    • Progression Free Survival (PFS): This will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression or death.

    • Response to second line protocol therapy on progression will be assessed using RECIST criteria as described for the primary endpoint.

    • Time to Treatment Failure (TTF): This will be defined as time from randomisation to
    discontinuation of protocol treatment for any reason, or progression of disease as defined by RECIST.

    • Overall Survival (OS): This will be defined as time from randomisation until death from any cause in the intention to treat population.

    • Toxicity: This will be assessed throughout the treatment period using the NCI CTC AE v3.0 (see Appendix 6 of trial protocol).

    • Frequency of development of symptomatic new cerebral metastases
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until evidence of disease progression (on second line protocol therapy) or treatment withdrawal due to any drug-related serious adverse event or patient choice.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned140
    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 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
    Definition of the end of the trial is 30 days after the last patient receives the last dose of the investigational medicinal product.

    However patients will be followed up longer term, the duration of time for which patient follow up data will be collected is dependent on future funding arrangements.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 2008-02-20. 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 state450
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 450
    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)
    Eligible patients will be randomised to receive 6 treatment cycles of either carboplatin AUC 6 every three weeks, or docetaxel 100mg/m2 iv every three weeks. A CT assessment after 3 cycles will be performed. Patients who progress after the initial 3 cycles, (defined by RECIST criteria – see clinical trial protocol appendix 2), will be offered 6 cycles of the alternative treatment arm.
    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 Decision2007-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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