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    Summary
    EudraCT Number:2012-002525-29
    Sponsor's Protocol Code Number:UC-0140/1206
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2012-002525-29
    A.3Full title of the trial
    A phase II trial evaluating the Activity of Abiraterone Acetate plus Prednisone in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abiraterone acetate in Molecular Apocrine breast cancer
    A.3.2Name or abbreviated title of the trial where available
    AMA
    A.4.1Sponsor's protocol code numberUC-0140/1206
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportLaboratory JANSSEN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointChristine ORSINI
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number01.71.93.67.07
    B.5.5Fax number01.44.23.04.69
    B.5.6E-mailc-orsini@unicancer.fr
    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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.4Pharmaceutical form 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 INNABIRATERONE ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Molecular apocrine locally advanced or metastatic breast cancer
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    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 10006187
    E.1.2Term 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
    To estimate antitumor activity of abiraterone acetate, as measured by the 6 months clinical benefit rate (CBR) in molecular apocrine HER2-negative locally advanced or metastatic breast cancer.
    E.2.2Secondary objectives of the trial
    - Objective response rate (ORR)
    - Duration of overall response (DoR).
    - Overall survival (OS)
    - Progression-free survival (PFS)
    - Tolerance and safety of abiraterone acetate.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To identify biomarkers of response to Abiraterone acetate using tumour tissue samples (from the primary tumour or from metastatic sites) and blood and serum samples. Translational research studies will include IHC, metabolomics, proteomics, pharmacogenetic and pharmacodynamic (tumour biomarkers, blood endocrine profile).
    To improve molecular definition of apocrine breast cancer (qRT-PCR, CGH, gene expression profiling)
    To describe the variation of CTC (Circulating Tumour Cells) levels and to evaluate the predictive value of the variation of CTC levels on the objective response rate, the clinical benefice rate and survival.
    E.3Principal inclusion criteria
    1) Women aged ≥ 18 years,
    2) Histologically confirmed locally advanced or metastatic breast cancer,
    3) Triple negative breast cancer:
    Estrogen receptor (ER)-negative and Progesteron receptor (PR)-negative, as defined by a < 10 % tumour stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from either primary or metastatic breast cancer site*,


    * In case of discordant ER and/or PR status between the primary tumour and the metastatic site, the status of the metastatic site will be used to decide whether the patient would be eligible or not
    4) Androgen receptor (AR)-positive, as defined centrally by a ≥ 10% tumour stained cells by IHC (AR assessment by local pathologist before inclusion is not mandatory),
    5) Patients could be chemotherapy naïve (provided they are not presenting with life-threatning metastasis) or have received any number of previous lines of chemotherapy (providing their life expectancy is ≥ 3 months),
    6) Pre and post menopausal patients are eligible. In the exceptional situation of a premenopausal patient, the addition of LHRH analog is recommended (androgens might act as an estrogen antagonist in premenopausal patients),
    7) Measurable or non measurable disease according to RECIST v1.1 criteria,
    8) PS (ECOG) ≤ 2,
    9) Normal haematological function: ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 10 g/dl,
    10) Normal hepatic function: total bilirubin ≤ 1.5 upper normal limit (UNL); ASAT and ALAT ≤ 2.5 UNL (≤ 5 UNL in the presence of liver metastases),
    11) Creatinine clearance (MDRD formula) ≥ 50 mL/min OR creatinine ≤ 1.5 times ULN,
    12) Normal kalemia (serum potassium ≥ 3.5mM), natremia and magnesaemia,
    13) Systolic blood pressure (BP) < 160 mm Hg and diastolic BP < 95 mm Hg, as documented on inclusion day (Hypertension at baseline assessment allowed provided it is currently controlled under anti-hypertensive drugs),
    14) Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion,
    15) If receiving a bisphosphonate or denosumab, dose must have been stable for at least 2 doses before inclusion,
    16) Patient agreeing to use effective contraception during and for ≥ 6 months after completion of study treatment,
    17) Patient able to comply with the protocol,
    18) Patient must have signed a written informed consent form prior to any study specific procedures,
    19) Patient must be affiliated to a Social Health Insurance.
    E.4Principal exclusion criteria
    1) Male breast cancer,
    2) HER2-positive status (positivity defined as IHC3+ and/or FISH amplification >2.2),
    3) Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥ 5 years and patient is deemed to be at low risk for recurrence,
    4) Active brain metastases or leptomeningeal disease; History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain,
    5) Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk,
    6) Significant cardiovascular disease, including any of the following:
    a) NYHA class III-IV congestive heart failure
    b) Unstable angina pectoris or myocardial infarction within the past 6 months
    c) Severe valvular heart disease
    d) Ventricular arrhythmia requiring treatment,
    7) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included,
    8) Persistent toxicities ≥ grade 2 from any cause, except chemotherapy-induced alopecia and Grade 2 peripheral neuropathy,
    9) Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy,
    10) Any gastrointestinal disorder interfering with absorption of the study drug,
    11) Difficulties with swallowing study capsules,
    12) Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) within the last 3 weeks (2 weeks for oral or weekly CT ; 6 weeks for nitrosoureas and mitomycin C), or other investigational agents ; Concurrent palliative radiotherapy allowed,
    13) Concurrent enrolment in another clinical trial in which investigational therapies are administered,
    14) Pregnant women, women who are likely to become pregnant or are breast-feeding,
    15) Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
    16) Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol,
    17) Individual deprived of liberty or placed under the authority of a tutor.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical benefit rate (CBR) :
    The 6-months CBR is the measurement of all patients who have a complete response (CR), partial response (PR) or stable disease (SD), according to RECIST criteria v1.1.
    E.5.2Secondary end point(s)
    Efficacy:
    - Objective response rate (ORR)
    The Objective response is defined as complete response (CR) or partial response (PR) according to RECIST criteria v1.1.
    - Duration of overall response (DoR)
    The DoR is defined as the time from documentation of tumour response (CR/PR) to disease progression, according to RECIST criteria v1.1.
    - Overall Survival (OS)
    The OS is defined as the time from the first administration of abiraterone acetate to death from any cause.
    - Progression-free survival (PFS)
    The PFS is defined as the time from the first administration of abiraterone acetate to progression (or death of any cause, whichever occurs first


    Safety:
    - Evaluation of Toxicity
    Safety will be evaluated by type, frequency and severity of adverse drug reactions according to NCI-CTC (v4.0): In order to be considered evaluable for toxicity, patients should have received at least one dose of treatment.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    IHC, metabolomics, proteomics and CTC analysis
    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) No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned25
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 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 state31
    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 Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
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