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    Clinical Trial Results:
    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.

    Summary
    EudraCT number
    2012-002525-29
    Trial protocol
    FR  
    Global end of trial date
    15 Jul 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Sep 2022
    First version publication date
    24 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UC-0140/1206
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01842321
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UNICANCER
    Sponsor organisation address
    101 RUE DE TOLBIAC, PARIS, France, 75013
    Public contact
    Nourredine AIT RAHMOUNE, UNICANCER, +33 171936704, n.ait-rahmoune@unicancer.fr
    Scientific contact
    Nourredine AIT RAHMOUNE, UNICANCER, +33 171936704, n.ait-rahmoune@unicancer.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    In order to ensure the protection of the rights, safety and well-being of trial subjects, this clinical trial was performed in compliance with the principles laid down in the declaration of Helsinki, good Clinical Practice and European regulation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jun 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    18
    From 65 to 84 years
    15
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment only in France, Date of first inclusion: 26-Jun-2013 Date of last inclusion: 24-Dec-2014

    Pre-assignment
    Screening details
    All women 18+, with a confirmed locally advanced or metastatic Triple Negative Breast Cancer (TNBC), will be screened and invited to participate. Only patients with a centralized confirmation of ER-/PR-/HER2- and evaluation of AR+ were included.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Abiraterone Acetate
    Arm description
    Only one arm in this trial Treatment: abiraterone acetate plus prednisone
    Arm type
    Experimental

    Investigational medicinal product name
    ABIRATERONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive abiraterone acetate at 1,000 mg (four 250 mg tablets daily in the morning after an overnight fast) concurrently with prednisone(1) at 10 mg once daily

    Number of subjects in period 1
    Abiraterone Acetate
    Started
    34
    Completed
    30
    Not completed
    4
         Discontinuation before end of first cycle
    1
         Disease progression before end of first cycle
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    34 34
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    18 18
        From 65-84 years
    15 15
        85 years and over
    1 1
    Gender categorical
    Units: Subjects
        Female
    34 34
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Abiraterone Acetate
    Reporting group description
    Only one arm in this trial Treatment: abiraterone acetate plus prednisone

    Primary: Primary endpoint

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    End point title
    Primary endpoint [1]
    End point description
    CBR is defined as: • Numerator: total number of patients who show a complete response (CR), partial response (PR), or stable disease (SD) for ≥6 months. • Denominator: total number of assessable patients for the primary endpoint
    End point type
    Primary
    End point timeframe
    The primary endpoint was the clinical benefit rate (CBR) defined as the percentage of patients who had a complete response (CR), partial response, or stable disease (SD) ≥6 months, according to RECIST v1.1.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statiscal analyses for the primary end point. A single stage study design was used to discriminate between a 15 and 35% clinical benefit rate (CBR).
    End point values
    Abiraterone Acetate
    Number of subjects analysed
    30
    Units: Number
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Reporting from the signing of the 1st consent form, until 30 days following the last administration of the experimental treatment
    Adverse event reporting additional description
    Occurrences all number for each non serious adverse event is not available. the number of subject affected by the non serious adverse event is reported in the "Occurrences all number" field.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    -

    Serious adverse events
    all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 34 (44.12%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic bone pain
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumor progression
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Injury, poisoning and procedural complications
    Iatrogenic pneumothorax
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Knee fracture
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Blood and lymphatic system disorders
    Lymphocele
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Acute cholecystitis
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumopathy
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    all patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 34 (100.00%)
    Investigations
    Hypokalaemia
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Hypophosphataemia
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    metastatic pain
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5
    Breast pain
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    10 / 34 (29.41%)
         occurrences all number
    10
    Insomnia
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    pain
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5
    Pain in extremity
         subjects affected / exposed
    7 / 34 (20.59%)
         occurrences all number
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 34 (23.53%)
         occurrences all number
    9
    Constipation
         subjects affected / exposed
    9 / 34 (26.47%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    7 / 34 (20.59%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    3 / 34 (8.82%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Chest pain
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Pleural effusion
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5
    Muscle spasms
         subjects affected / exposed
    2 / 34 (5.88%)
         occurrences all number
    2
    Musculoskeletal pain
         subjects affected / exposed
    4 / 34 (11.76%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 34 (14.71%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Dec 2013
    This translational research program is aiming 1. To validate or identify a “molecular apocrine signature” using a variety of methods including a RT-qPCR (ER, AR, FOXA1 and 5 genes involved in the AR pathway) and IHC markers (ER, PR, HER2, CK5/6, CK17, EGFR, Ki67, AR, FOXA1 et GCDFP15) which identified molecular apocrine tumours with an excellent accuracy in a recent publication (Lehmann-Che J BCR 2013). In their series androgen receptors (AR) assessment by immunohistochemistry (IHC) was negative in 42% of molecular apocrine tumours (defined by expression arrays). In AMA trial (Caduseime 02) we will not change the first inclusion criteria which is “molecular apocrine tumour defined by IHC” but we will analyse by RT-PCR quantitative and IHC as mentioned above in tumour samples from eligible patients, and non-eligible patients (meaning not identified as molecular apocrine after central review with standard IHC analysis including AR). The identification of a “molecular apocrine signature” with a high accuracy should have important consequences for patient selection in further trials.
    16 May 2014
    The protocol and the information sheet were updated in order to take into account last modifications on investigator's brochure
    07 Jan 2015
    clarifications made to an inclusion criterion and to the main evaluation criterion

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Occurrences all number for each non serious adverse event is not available. the number of subject affected by the non serious adverse event is reported in the "Occurrences all number" field.
    For support, Contact us.
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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