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    Summary
    EudraCT Number:2014-000918-61
    Sponsor's Protocol Code Number:
    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:2014-05-22
    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 number2014-000918-61
    A.3Full title of the trial
    A randomised phase II pilot study of 3 weekly Cabazitaxel versus weekly Paclitaxel chemotherapy in the first line treatment of HER2 negative metsastatic breast cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of 3 weekly cabazitaxel versus weekly pactlitaxel for the first treatment of metastatic breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    CONCEPT
    A.4.1Sponsor's protocol code number
    A.5.4Other Identifiers
    Name:CONCEPTNumber:ON/2012/4234
    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 SponsorUniversity Hospitals Bristol NHS Foundation trust
    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 supportAventis pharmaceuticals limited (trading as Sanofi)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospitals Bristol NHS Foundation trust
    B.5.2Functional name of contact pointSylvia Pearson
    B.5.3 Address:
    B.5.3.1Street AddressClinical trials unit, Bristol Haematology + Oncology Centre
    B.5.3.2Town/ cityBristol
    B.5.3.3Post codeBS2 8ED
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01173426747
    B.5.5Fax number01173422738
    B.5.6E-mailsylvia.pearson@uhbristol.nhs.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 Jevtana
    D.2.1.1.2Name of the Marketing Authorisation holderAventis pharmaceuticals Ltd (trading as Sanofi)
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCabazitaxel
    D.3.4Pharmaceutical form Concentrate 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 INNCABAZITAXEL
    D.3.9.1CAS number 183133-96-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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.2.1.1.1Trade name Taxol
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePaclitaxel
    D.3.4Pharmaceutical form
    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 INNPaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic breast cancer
    E.1.1.1Medical condition in easily understood language
    Breast cancer which has spread to other parts of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    Assessment in the difference of progression free survival between the 2 groups defined as either the development of disease profgression or death from any cause.
    E.2.2Secondary objectives of the trial
    To determine the best response rate in each group recorded from the start of treatment to the completion of 6 cycles of treatment.
    The time to response in each group taken from the time of registration to the CT scan showing a partial response.
    Overall survival
    To evaluate the safety and tolerability by assessing the occurence of grade 3 or greater toxicities between the start of treatment and disease progression and the number of serious adverse events.
    To assess the quality of life using EQ-5D and FACT -B questionnaires.
    The time to the next cytotoxic chemotherapy treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Circulating tumour cells- Bristol site only. Copy paragraph from Bristol Bladder A13 baseline, prior to cycles 3 + 5 and end of treatment. The aim of the study is to determine the sensitivity, specificity, positive and negative predictive value of repeated CTC measurement for early prediction of the presence or absence of a radiological response to cabazitaxel chemotherapy in the treatment of HER2 negative breast cancer.
    E.3Principal inclusion criteria
    Written informed consent
    Metastatic breast cancer, fit to receive cytotoxic chemotherapy as palliative treatment.
    Measurable disease as per RECIST 1.1 by CT or MRI within 4 weeks of registration.
    ECOG performance status 0 or 1
    No prior cytotoxic chemotherapy for metastatic disease. Neoadjuvant or adjuvant chemotherapy permitted if given more than 3 months prior to registration.
    Patients may be taxane naive or have received docetaxel chemotherapy in the adjuvant setting.
    Prior histology to confirm HER 2 negative defined as IHC 0+, 1+ or IHC 2+ with FISH/SISH/CISH (Ratio <2.0)in case of IHC 2+
    ER+ and ER- Both eligible.
    Age ≥ 18
    Anticipated life expectancy >6 months.
    Adequate liver, renal and bone marrow function defined as:
    Haemoglobin >9.0g/dL
    Absolute neutrophil count > 1.5 x 10^9/L
    Platelet count >100 x 10^9/L
    ALT< 2.5 X ULN
    Total bilirubin < 1.0 x ULN
    Serum creatinine < 1.5 x ULN
    Negative pregnancy test bu urine or serum within 7 days prior to randomisation for all women of child bearing potential
    Complete staging work up within 4 weeks prior to randomisation.
    Patients must be available and compliant for diagnostics, treatment and follow up.
    E.4Principal exclusion criteria
    HER 2 + breast cancer (IHC 3+ or FISH/SISH/CISH ratio 2.0 )
    Previous paclitaxel chemotherapy in the adjuvant setting.
    Prior cytotoxic chemotherapy for metastatic disease.
    Palliative radio therapy for metastatic disease within 4 weeks of randomisation.
    Symptomatic brain metastases.
    History or other malignancy (excluding non-melanomatous skin cancer).
    Grade ≥ 2 peripheral motor +/or sensory neuropathy.
    Grade ≥ 2 oral mucositis.
    History of severe hypersensitivity reaction (≥ grade 3) to taxanes.
    History of severe hypersensitivity reaction (≥ grade 3) to polysorbate 80- containing drugs.
    Clinically significant (active) cardiovascular disease, including cerebrovascular accident (within 6 months before enrolment), myocardial infarction, arterial thrombotic events within 6 months before enrolment, unstable angina pectoris, New York heart association grade 2 congestive heart failure, serious cardiac arrythmia requiring medication during the study and that might intefere with regularity of the study treatment, or not controlled by medication.
    Any severe acute or chronic medical condition which could impair the ability of the patient to participate in the study or comply with the study procedures or interfere with interpretation of study results.( such as significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures.)
    Active infection requiring systemic antibiotics or antifungal medication.
    Prior endocrine therapy treatment must be stopped before study entry.
    Concurrent treatment on another clinical trial.
    Requirement for radiation therapy concurrent withthe study.
    Inability and unwillingness to comply with study visits, treatment, testing and to comply with the protocol.
    Other concurrent serious illness or medical conditions which make it undesirable for the patient to enter the trial including uncontrolled diabetes mellitus.
    Inadequate organ and bone marrow function as evidenced by :
    Haemoglobin <9.0g/L
    Absolute neutrophil count < 1.5 x 10^9
    AST>2.5 x ULN
    Total bilirubin > 1.5 x ULN
    Serum creatinine > 1.5 x ULN. If creatinine is 1.0-1.5 x ULN, creatinine clearnace will be calculated according to CKD-EPI formula and patients with creatinine clearance <60mls/min should be excluded. (See appendix 2 for formula)
    Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. ( A one week washout period is necessary for patients who are already on these treatments. (Appendix 4)
    Participation in another clinical trial with any investigational drug within 30 days prior to randomisation.
    Pregnancy or breast feeding women.
    Patients with child bearing potential who do not agree to use accepted and effective method of contraception ( barrier method, intrauterine devices, sterilisation) during the study treatment period and for a period of 12 months after the last study drug administration..
    Contraindications to the use of corticosteroid treatment.


    Grade ≥ 2 peripheral neuropathy
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival between the two groups from randomisation to either death or disease progression.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary efficacy endpoint is the PFS, defined as the time interval between the date of randomisation and the date of tumour progression (defined according to RECIST version 1.1) or death from any cause, whichever comes first. In the absence of confirmation of disease progression or death, PFS time will be censored at the earlier between the date of last valid tumour assessment without evidence of tumour progression and the cut-off date. PFS for patients who have no tumour assessments after baseline and do not die will be censored on the day of randomisation (Day 1).
    PFS will be compared between the two treatments by the log-rank test procedure stratified by previous chemotherapy in adjuvant setting (docetaxel vs No docetaxel) and subtype tumour (ER positive or negative) as specified at the
    E.5.2Secondary end point(s)
    Response Rates
    Tolerability and Safety
    Overall Survival
    Quality of Life
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints analysis
    Response rates will be estimated as the number of patients with clinical benefit rate (CR + PR + SD) and objective response (CR+PR) recorded from the start of treatment to the completion of 6 cycles of treatment.

    Overall Survival will be defined as the time period between randomisation and death and will be analysed after the end of the study by referring to data from the hospital statistics.
    Quality of Life : FACT-B and EQ-5D scores will be presented by treatment group at baseline, prior to cycles 3 and 5 and at the end of treatment visit.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days31
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    Treatment will be done as per standard of care available in the NHS for care of metastatic breast cancer. Participation in this trial will not interfere with any subsequent planned treatment for this group of patients.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-07
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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