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    Clinical Trial Results:
    Neoadjuvant study of targeting ROS1 in combination with endocrine therapy in invAsive Lobular carcINoma of the breast

    Summary
    EudraCT number
    		 2019-004942-14
    Trial protocol
    		 BE   FR  
    Global end of trial date
    17 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2026
    First version publication date
    29 Jul 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IJB-LOB-2019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04551495
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut Jules Bordet
    Sponsor organisation address
    Rue Meylemeersch, 90, Anderlecht, Belgium, 1070
    Public contact
    Study Chair, Dr. Philippe Aftimos, +32 025413208, philippe.aftimos@hubruxelles.be
    Scientific contact
    CTC, Institut Jules Bordet, ROSALINE.ctc@hubruxelles.be
    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
    24 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of endocrine therapy + entrectinib in women with ER-positive/HER2-negative early breast cancer of the lobular subtype
    Protection of trial subjects
    An IDMC took place on the 16-Sep-22 and the IDMC had no objection to the continuation of the trial to stage II.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 37
    Country: Number of subjects enrolled
    France: 19
    Worldwide total number of subjects
    56
    EEA total number of subjects
    56
    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)
    44
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 08/01/2021 and 15/03/2024, participants were recruited in 10 participating sites in 2 countries (Belgium and France)

    Pre-assignment
    Screening details
    		 Once informed consent was signed, inclusion and exclusion criteria were double checked to identify any screening failure. They were reported in the trial registration tool.

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

    Arms
    Arm title
    		 Single arm trial
    Arm description
    		 This single arm, multi-center, phase 2 trial will include pre and post-menopausal women with ER-positive/HER2-negative early stage invasive lobular carcinoma of the breast to evaluate the effect of combining endocrine therapy with entrectinib. Surgery took place after at least 16 weeks of treatment, during week 18 (+ 7-day window). Intervention information: Participants received four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women received goserelin 3.6 mg every 28 days. Surgery took place after at least 16 weeks of treatment, during week 18 (+ 7-day window).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Femara®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women received goserelin 3.6 mg every 28 days.

    Investigational medicinal product name
    Entrectinib
    Investigational medicinal product code
    Other name
    Rozlytrek
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women received goserelin 3.6 mg every 28 days.

    Investigational medicinal product name
    Goserelin
    Investigational medicinal product code
    Other name
    Zoladex 3.6 mg Implant
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Participants received four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women received goserelin 3.6 mg every 28 days.

    Number of subjects in period 1
    		Single arm trial
    Started
    56
    Completed
    49
    Not completed
    7
         Consent withdrawn by subject
    1
         Ductal carcinoma found in baseline biopsy in addit
    1
         Adverse event, non-fatal
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Single arm trial
    Reporting group description
    		 This single arm, multi-center, phase 2 trial will include pre and post-menopausal women with ER-positive/HER2-negative early stage invasive lobular carcinoma of the breast to evaluate the effect of combining endocrine therapy with entrectinib. Surgery took place after at least 16 weeks of treatment, during week 18 (+ 7-day window). Intervention information: Participants received four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women received goserelin 3.6 mg every 28 days. Surgery took place after at least 16 weeks of treatment, during week 18 (+ 7-day window).

    Reporting group values
    		 Single arm trial Total
    Number of subjects
    		 56 56
    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)
    		 44 44
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 56 ( 9.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 56
        Male
    		 0 0
    Menopausal characteristics
    Units: Subjects
        Premenopausal
    		 23 23
        Postmenopausal
    		 33 33
    Tumor laterality
    Units: Subjects
        Bilateral
    		 1 1
        Left
    		 22 22
        Right
    		 33 33
    Primary tumor location
    Units: Subjects
        Breast
    		 56 56
    Invasive emboli/invasion
    Units: Subjects
        Yes
    		 5 5
        No
    		 48 48
        Unkown
    		 3 3
    Multifocal tumor
    Units: Subjects
        Yes
    		 13 13
        No
    		 43 43
    Clinical Tumor Stage
    Units: Subjects
        T1c
    		 1 1
        T2
    		 28 28
        T3
    		 27 27
    Clinical Tumor Stage
    Units: Subjects
        N0
    		 35 35
        N1
    		 21 21
    Clinical Stage (Cancer Characteristics)
    Units: Subjects
        IIA
    		 20 20
        IIB
    		 25 25
        IIIA
    		 11 11
    Histological Grade
    Units: Subjects
        G1: well differentiated
    		 7 7
        G2: Moderately differentiated
    		 43 43
        G3: Poorly differentiated
    		 5 5
        Missing
    		 1 1
    ECOG at screening
    Units: Subjects
        Zero
    		 45 45
        One
    		 8 8
        Missing
    		 3 3
    ECG at screening
    Units: Subjects
        Normal (clinical significance)
    		 40 40
        Abnormal (clinical significance)
    		 16 16
    Prior systemic therapies
    Units: Subjects
        Yes
    		 0 0
        No
    		 56 56
    Biomarker at screening - ER positive status
    Units: Subjects
        Yes
    		 56 56
        No
    		 0 0
    Biomarker at screening - PR (all PR were the same in all tested foci)
    Units: Subjects
        Yes
    		 54 54
        No
    		 2 2
    Biomarker at screening - HER2 IHC
    Units: Subjects
        Zero
    		 23 23
        1+
    		 20 20
        2+
    		 13 13
    Biomarker at screening - KI67
    Units: Subjects
        <20%
    		 40 40
        >20%
    		 11 11
        Missing
    		 5 5
    Age at inclusion
    Units: year
        median (full range (min-max))
    		 56 (35 to 78) -
    Biomarker at screening - PR Rsults
    Units: percent
        arithmetic mean (standard deviation)
    		 23.3 ( 30.43 ) -

    End points

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    End points reporting groups
    Reporting group title
    Single arm trial
    Reporting group description
    		 This single arm, multi-center, phase 2 trial will include pre and post-menopausal women with ER-positive/HER2-negative early stage invasive lobular carcinoma of the breast to evaluate the effect of combining endocrine therapy with entrectinib. Surgery took place after at least 16 weeks of treatment, during week 18 (+ 7-day window). Intervention information: Participants received four 28-day cycles of letrozole 2.5 mg daily in combination with entrectinib 600 mg daily. Pre-menopausal women received goserelin 3.6 mg every 28 days. Surgery took place after at least 16 weeks of treatment, during week 18 (+ 7-day window).

    Subject analysis set title
    Evaluable Participants
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    all evaluable participants defined as participant : *who started the combined schedule of letrozole and entrectinib *who did not miss more than 18 days of entrectinib, to have a minimal dose of intensity of 85% *Who was surgically treated and *for whom he criteria for assessing RCB can be applied *For whom the RCB, ypTNM and loa-cally-assessed breast MRI (tumor objective response) data was collected)

    Primary: Observed proportion of residual cancer burden (0/1) estimated to be equal to 3% to the theoretical proportion of 15%

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    End point title
    		 Observed proportion of residual cancer burden (0/1) estimated to be equal to 3% to the theoretical proportion of 15% [1]
    End point description
    The primary efficacy analysis tests the hypothesis of equality of observed proportion of residual cancer burden (0/1) estimated to be equal to 3% to the theoretical proportion of 15%. The study will then test the null hypothesis that the rate of RCB 0/1 is less or equal than 3% versus that this rate is greater than 3% with the desired power to be reached in case this rate is greater or equal than 15%. One-sided level of alpha =10% and bêta =10% have been used for sample size determination. The analyses are performed on the evaluable set (n = 41). We observe 0/41 participant with RCB equal to 0 or 1. Under the Simon’s design, we cannot reject the null hypothesis because no patient had RCB « 0/1 ». Level of confidence interval is 90 % ; one side Parameter type is the proportion of residual cancer burden (0/1)
    End point type
    Primary
    End point timeframe
    At surgery, after neoadjuvant treatment
    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: This is single arm study
    End point values
    		 Evaluable Participants
    Number of subjects analysed
    41
    Units: Participants
        RCB 0/1
    0
        RCB 2/3
    41
    No statistical analyses for this end point

    Secondary: Number of patients with pCR and axilla by local evaluation

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    End point title
    		 Number of patients with pCR and axilla by local evaluation
    End point description
    The number of participants with pCR and axilla by local evaluation is 0/41
    End point type
    Secondary
    End point timeframe
    At surgery
    End point values
    		 Single arm trial Evaluable Participants
    Number of subjects analysed
    56
    41
    Units: Participants
    56
    41
    No statistical analyses for this end point

    Secondary: Number of participants with best overall rate response

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    End point title
    		 Number of participants with best overall rate response
    End point description
    There are 20/41 (p ̂=0.4878; 95% CI= [0.3348-0.6408], in percent 48.78%) patients with complete RECIST response evaluation or partial RECIST response evaluation.
    End point type
    Secondary
    End point timeframe
    At surgery
    End point values
    		 Single arm trial Evaluable Participants
    Number of subjects analysed
    56
    41
    Units: Participants
    56
    41
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first administration of study treatment until 30 days after the last administration of study treatments, all AEs should be reported. From 31 days after last administration of study treatment, only SAEs related to study treatment must be reported
    Adverse event reporting additional description
    If the participant receives goserelin during the screening period, the reporting of all SAEs starts at the goserelin administration date.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Overall trial

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 56 (7.14%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Enterococcal sepsis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 56 (98.21%)
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Hot flush
         subjects affected / exposed
    9 / 56 (16.07%)
         occurrences all number
    10
    Hypotension
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Lymphocele
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Orthostatic hypotension
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Peripheral venous disease
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 56 (21.43%)
         occurrences all number
    12
    Face oedema
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    24 / 56 (42.86%)
         occurrences all number
    25
    Malaise
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Mucosal inflammation
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Oedema
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    16 / 56 (28.57%)
         occurrences all number
    19
    Pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Swelling face
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast discharge
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Vulvovaginal dryness
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Dysphonia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    11 / 56 (19.64%)
         occurrences all number
    12
    Dyspnoea exertional
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Hyperventilation
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Nasal inflammation
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Confusional state
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Hallucination
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    3
    Irritability
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Libido decreased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Mood altered
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Blood creatine increased
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Troponin increased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Weight increased
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Injury, poisoning and procedural complications
    Breast injury
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Foot fracture
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Procedural pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Wrist fracture
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    2
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Allodynia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Amnesia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Ataxia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Balance disorder
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    Cognitive disorder
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Disturbance in attention
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    10 / 56 (17.86%)
         occurrences all number
    11
    Dysaesthesia
         subjects affected / exposed
    9 / 56 (16.07%)
         occurrences all number
    9
    Dysarthria
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Dysgeusia
         subjects affected / exposed
    34 / 56 (60.71%)
         occurrences all number
    37
    Dyskinesia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    5
    Hyperaesthesia
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Hypotonia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Language disorder
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Memory impairment
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    9 / 56 (16.07%)
         occurrences all number
    9
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    9 / 56 (16.07%)
         occurrences all number
    10
    Polyneuropathy
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Restless legs syndrome
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Taste disorder
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Lymphopenia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    27 / 56 (48.21%)
         occurrences all number
    29
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Photopsia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Visual impairment
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Abdominal pain lower
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Cheilitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    40 / 56 (71.43%)
         occurrences all number
    45
    Diarrhoea
         subjects affected / exposed
    16 / 56 (28.57%)
         occurrences all number
    17
    Dry mouth
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Dysphagia
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Hypoaesthesia oral
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    18 / 56 (32.14%)
         occurrences all number
    19
    Odynophagia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Oral hyperaesthesia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Paraesthesia oral
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Saliva altered
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    10 / 56 (17.86%)
         occurrences all number
    11
    Tongue discomfort
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Pain of skin
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    7
    Rash
         subjects affected / exposed
    7 / 56 (12.50%)
         occurrences all number
    7
    Rash maculo-papular
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Sensitive skinkin
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Dysuria
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Renal failure
         subjects affected / exposed
    4 / 56 (7.14%)
         occurrences all number
    4
    Renal impairment
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 56 (37.50%)
         occurrences all number
    23
    Back pain
         subjects affected / exposed
    2 / 56 (3.57%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Muscular weakness
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    6
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    12 / 56 (21.43%)
         occurrences all number
    12
    Neck pain
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Pain in jaw
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Torticollis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    5 / 56 (8.93%)
         occurrences all number
    5
    Cystitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Pseudomonas infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 56 (10.71%)
         occurrences all number
    7
    Fluid retention
         subjects affected / exposed
    3 / 56 (5.36%)
         occurrences all number
    3
    Hypercreatininaemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1
    Increased appetite
         subjects affected / exposed
    1 / 56 (1.79%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Apr 2021
    BELGIUM Site agreement initial IJB/UCL St Luc/GHDC/Ste Elisabeth Namur New/amended patient information sheet / informed consent (including addendum) v2.0 + addendum A New/amended protocol v1.3 *Summary of changes in resquest from ANSM & CPP *addition of triple ECG before start of C3 & C4 *modification IC5 & EC1, EC4,EC10, EC12
    30 Jul 2021
    BELGIUM Addition of at least a new site or a site whose LEC did not reply initially or moved site *Addition of a site: UZ Leuven Site agreement initial UZ Brussels/ UZ Gent Site agreement amdt1UZ Brussels/ GHDC/ Ste Elisabeth Namur/ UCL St Luc
    29 Nov 2021
    BELGIUM Addition of at least a new site or a site whose LEC did not reply initially or moved site *IJB address change
    22 Mar 2022
    FRANCE New/amended patient information sheet / informed consent (including addendum) *ICF v2.0 + Addendum A *ICF 1.2 *ICF Pregnancy v1.1 New/amended Reference Safety Information *IB entrectinib v11 *Labels letrozole + goserelin v2.0 New/amended protocol *Protocol v2.0: Change IC4, section 6. 4 Cf new IB Entrectinib v11, EC7 Synopsis v2.0 Carte urgence v2.0 Annual Study progress Report v1 Change IJB address in all docs
    14 Apr 2022
    BELGIUM New/amended Reference Safety Information *IB v11 *Labels v2.0 letrozole + goserelin New/amended patient information sheet / informed consent (including addendum) *ICF v3.0 + Addendum B FR, NL, EN + SoC *ICF 2.1 FR, NL, EN (notification) *ICF Pregnancy 1.1 FR, NL, EN New/amended protocol *Protocol v2.0 FR, NL, EN + SoC : Change IC4, section 6. 4 Cf new IB Entrectinib v11, EC7 Synopsis v2.0 FR, NL, EN Patient emergency cards v2.0 Annual study progress report Site contracts : UZ Leuven initial ; UZ Gent Change IJB address in all docs
    24 Jan 2023
    FRANCE New/amended patient diary *Patient diary v2.0 New/amended patient information sheet / informed consent (including addendum) *ICF v3.0 + Addendum C FR + SoC New/amended documents or information related to IMP or IMPD: IB v12 Changes in the logistics of the trial, which are NOT site-related (ex: lab, CRO etc) Change of PI – already approved site *Change of PI IGR: CV & GCP Dr Ribeiro New/amended protocol *Protocol v3.0 + SoC: Increase of the patients to enrol number & increase of the study duration following IDMC recommendation Synopsis v3.0 FR Insurance certificate
    02 Mar 2023
    BELGIUM New/amended protocol *Protocol v3.0 + SoC : Increase of the patients to enrol number & increase of the study duration following IDMC recommendation New/amended patient information sheet / informed consent (including addendum): ICF v4.0 + Addendum C FR, EN, NL + SoC New/amended other study documents *Synopsis v3.0 FR, EN, NL *Insurance certificat New/amended Reference Safety Information: IB v12 New/amended patient diary: Patient diary v2.0

    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.
    There were no limitations and caveats.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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