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    Clinical Trial Results:
    Anti-hormonal maintenance treatment with the CDK4/6 inhibitor Ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial

    Summary
    EudraCT number
    2017-003667-35
    Trial protocol
    DE  
    Global end of trial date
    21 Jul 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Aug 2023
    First version publication date
    04 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GBG-97-AMICA
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03555877
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GBG Forschungs GmbH
    Sponsor organisation address
    Dornhofstr. 10, Neu-Isenburg, Germany, 63263
    Public contact
    Publications, GBG Forschungs GmbH, +49 610274800, publications@gbg.de
    Scientific contact
    Publications, GBG Forschungs GmbH, +49 610274800, publications@gbg.de
    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 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To estimate the median PFS with 95% confidence interval (CI) of an anti-hormonal maintenance therapy with the CDK4/6 inhibitor ribociclib after 1st line chemotherapy at the discretion of the investigator (e.g. taxanes, capecitabine, vinorelbine, anthracycline)
    Protection of trial subjects
    The trial protocol including amendments, patient information, and the informed consent were reviewed and approved from a properly constituted IRB/IEC for each site prior to the study start. The study was conducted in accordance with the Declaration of Helsinki and its revisions, the International Conference on Harmonization (ICH) - Harmonized Tripartite Guideline for Good Clinical Practice (GCP) (E6), and in accordance with applicable laws of the pertinent regulatory authorities in all aspects of preparation, monitoring, reporting, auditing, and archiving. IDMC was involved to ensure the ethical conduct of the trial and to protect patients' safety interests in this study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Feb 2018
    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
    Germany: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    28
    From 65 to 84 years
    23
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 13 sites in Germany (between March 2018 and July 2022). A total of 70 patients were screened, of whom 53 started treatment.

    Pre-assignment
    Screening details
    Women with HR+/HER2- locally advanced or metastatic BC with disease control (at least stable disease) after at least 4 cycles of a mono- or polychemotherapy and no more than one previous line of ET treatment; maintenance ET could have already been started up to 6 weeks before enrolment, but after achievement of tumor response or stable disease.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ribociclib + ET
    Arm description
    Ribociclib + ET (with anastrozole, letrozole, exemestane, or fulvestrant +/-LHRH-analogue for premenopausal women)
    Arm type
    Experimental

    Investigational medicinal product name
    Ribociclib
    Investigational medicinal product code
    Other name
    KISQALI®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribociclib at a dose of 600 mg (3x200mg) was administered orally once a day for 21 days followed by 7 days off treatment of every 28-day cycle

    Arm title
    ET alone
    Arm description
    ET alone (Anastrozole, Letrozole, Exemestane, or Fulvestrant). Premenopausal patients received LHRH-analogue in addition to ET. Note: This arm was not part of the modified intention-to-treat analysis (mITT), see Amendment 3.
    Arm type
    Descriptive

    Investigational medicinal product name
    Anastrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg tablets administered once per day orally

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg tablets administered once per day orally

    Investigational medicinal product name
    Exemestane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg tablets administered once per day orally

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    prefilled syringes with fulvestrant 250mg each: 500 mg given once a month intramuscularly, with an additional 500 mg dose given two weeks after the first dose.

    Number of subjects in period 1
    Ribociclib + ET ET alone
    Started
    43
    10
    Completed
    12
    1
    Not completed
    31
    9
         Physician decision
    1
    -
         Adverse event, non-fatal
    2
    -
         Death without documented progression
    1
    -
         Lost to follow-up
    1
    -
         Progressive disease
    25
    9
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ribociclib + ET
    Reporting group description
    Ribociclib + ET (with anastrozole, letrozole, exemestane, or fulvestrant +/-LHRH-analogue for premenopausal women)

    Reporting group title
    ET alone
    Reporting group description
    ET alone (Anastrozole, Letrozole, Exemestane, or Fulvestrant). Premenopausal patients received LHRH-analogue in addition to ET. Note: This arm was not part of the modified intention-to-treat analysis (mITT), see Amendment 3.

    Reporting group values
    Ribociclib + ET ET alone Total
    Number of subjects
    43 10 53
    Age categorical
    Units: Subjects
        < 40 years
    1 0 1
        40 - < 50 years
    5 0 5
        50 - < 65 years
    19 3 22
        65 years and above
    18 7 25
    Age continuous
    Units: years
        median (full range (min-max))
    61 (36 to 87) 70 (50 to 85) -
    Gender categorical
    Units: Subjects
        Female
    43 10 53
        Male
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Ribociclib + ET
    Reporting group description
    Ribociclib + ET (with anastrozole, letrozole, exemestane, or fulvestrant +/-LHRH-analogue for premenopausal women)

    Reporting group title
    ET alone
    Reporting group description
    ET alone (Anastrozole, Letrozole, Exemestane, or Fulvestrant). Premenopausal patients received LHRH-analogue in addition to ET. Note: This arm was not part of the modified intention-to-treat analysis (mITT), see Amendment 3.

    Primary: Progression-free survival

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    End point title
    Progression-free survival
    End point description
    Patients lost to follow-up or alive at the end of the study were censored at the date of last contact. In addition, patients starting a chemotherapy or targeted therapy after discontinuation of ET were censored at the date of the beginning of the new therapy.
    End point type
    Primary
    End point timeframe
    Time in months between enrolment and tumor progression or death from any cause.
    End point values
    Ribociclib + ET ET alone
    Number of subjects analysed
    43
    10
    Units: month
        median (confidence interval 95%)
    12.4 (8.7 to 24.4)
    4.75 (1 to 10.3)
    Statistical analysis title
    Kaplan – Meier method
    Statistical analysis description
    The median PFS and the corresponding 95% CI as well as the PFS curve were estimated using the Kaplan – Meier method. Patients lost to follow up or those who were progression-free at the end of the study were censored at the date of last contact. Patients starting a chemotherapy or targeted therapy after discontinuation of endocrine therapy were censored at the date of the beginning of the new therapy.
    Comparison groups
    Ribociclib + ET v ET alone
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 9999 [2]
    Method
    None
    Parameter type
    Confidence interval
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -
         upper limit
    -
    Variability estimate
    Standard error of the mean
    Notes
    [1] - Median PFS with corresponding 95% CIs were estimated, and survival curves were plotted (estimation via Kaplan-Meier)
    [2] - No p-value measured. Fields filled to avoid error.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events occurring during the study treatment period were reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Ribociclib + ET
    Reporting group description
    -

    Reporting group title
    ET only
    Reporting group description
    -

    Serious adverse events
    Ribociclib + ET ET only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 43 (25.58%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    14
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Spinal compression fracture
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis of jaw
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Ribociclib + ET ET only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 43 (100.00%)
    10 / 10 (100.00%)
    Vascular disorders
    Embolism
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    19 / 43 (44.19%)
    2 / 10 (20.00%)
         occurrences all number
    19
    2
    Mucosal inflammation
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Oedema peripheral
         subjects affected / exposed
    10 / 43 (23.26%)
    1 / 10 (10.00%)
         occurrences all number
    10
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    9 / 43 (20.93%)
    2 / 10 (20.00%)
         occurrences all number
    9
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Dyspnoea
         subjects affected / exposed
    12 / 43 (27.91%)
    1 / 10 (10.00%)
         occurrences all number
    12
    1
    Cough
         subjects affected / exposed
    7 / 43 (16.28%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Pleural effusion
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    5 / 43 (11.63%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    22 / 43 (51.16%)
    4 / 10 (40.00%)
         occurrences all number
    22
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    26 / 43 (60.47%)
    2 / 10 (20.00%)
         occurrences all number
    26
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    25 / 43 (58.14%)
    2 / 10 (20.00%)
         occurrences all number
    25
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    17 / 43 (39.53%)
    3 / 10 (30.00%)
         occurrences all number
    17
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 43 (13.95%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Dysgeusia
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Syncope
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorder
         subjects affected / exposed
    10 / 43 (23.26%)
    2 / 10 (20.00%)
         occurrences all number
    10
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    26 / 43 (60.47%)
    5 / 10 (50.00%)
         occurrences all number
    26
    5
    Leukopenia
         subjects affected / exposed
    41 / 43 (95.35%)
    1 / 10 (10.00%)
         occurrences all number
    41
    1
    Neutropenia
         subjects affected / exposed
    40 / 43 (93.02%)
    1 / 10 (10.00%)
         occurrences all number
    40
    1
    Thrombocytopenia
         subjects affected / exposed
    19 / 43 (44.19%)
    3 / 10 (30.00%)
         occurrences all number
    19
    3
    Febrile neutropenia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Dry eye
         subjects affected / exposed
    7 / 43 (16.28%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    22 / 43 (51.16%)
    3 / 10 (30.00%)
         occurrences all number
    22
    3
    Vomiting
         subjects affected / exposed
    9 / 43 (20.93%)
    0 / 10 (0.00%)
         occurrences all number
    9
    0
    Dyspepsia
         subjects affected / exposed
    7 / 43 (16.28%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Constipation
         subjects affected / exposed
    12 / 43 (27.91%)
    1 / 10 (10.00%)
         occurrences all number
    12
    1
    Diarrhoea
         subjects affected / exposed
    10 / 43 (23.26%)
    1 / 10 (10.00%)
         occurrences all number
    10
    1
    Gastrointestinal pain
         subjects affected / exposed
    11 / 43 (25.58%)
    0 / 10 (0.00%)
         occurrences all number
    11
    0
    Ascites
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    13 / 43 (30.23%)
    2 / 10 (20.00%)
         occurrences all number
    13
    2
    Alopecia
         subjects affected / exposed
    12 / 43 (27.91%)
    2 / 10 (20.00%)
         occurrences all number
    12
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 43 (20.93%)
    7 / 10 (70.00%)
         occurrences all number
    9
    7
    Myalgia
         subjects affected / exposed
    6 / 43 (13.95%)
    2 / 10 (20.00%)
         occurrences all number
    6
    2
    Back pain
         subjects affected / exposed
    11 / 43 (25.58%)
    1 / 10 (10.00%)
         occurrences all number
    11
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    10 / 43 (23.26%)
    1 / 10 (10.00%)
         occurrences all number
    10
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 43 (13.95%)
    1 / 10 (10.00%)
         occurrences all number
    6
    1
    Hypophosphataemia
         subjects affected / exposed
    15 / 43 (34.88%)
    1 / 10 (10.00%)
         occurrences all number
    15
    1
    Hypermagnesaemia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    29 / 43 (67.44%)
    4 / 10 (40.00%)
         occurrences all number
    29
    4
    Hyperkalaemia
         subjects affected / exposed
    22 / 43 (51.16%)
    5 / 10 (50.00%)
         occurrences all number
    22
    5
    Hypokalaemia
         subjects affected / exposed
    4 / 43 (9.30%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Hypercalcaemia
         subjects affected / exposed
    5 / 43 (11.63%)
    2 / 10 (20.00%)
         occurrences all number
    5
    2
    Hypocalcaemia
         subjects affected / exposed
    24 / 43 (55.81%)
    3 / 10 (30.00%)
         occurrences all number
    24
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Sep 2018
    Amendment 1 (Version 3.0 19-SEP-2018) of the study protocol included the following changes: • Exclusion criteria 2: Subjects who had previously received a CDK4/6 inhibitor was deleted • Due to safety reasons, tamoxifen was excluded from the list of ET which could be given to the patient at the discretion of the investigator. Tamoxifen could potentially increase the QT interval, a known toxicity also of ribociclib • Herbal medication was deleted from the list of prohibited medications • Surgery for primary tumor was permitted at the discretion of the investigator.
    22 Jan 2020
    Amendment 2 (Version 4.0 22-JAN-2020) included changes in study design and statistical assumptions, but it was not approved by the ethics committee.
    18 Jun 2020
    Amendment 3 (Version 5.0 18-JUN-2020) included the following changes: • Change of study design from two arms into one arm • Reduction of number of patients to be enrolled • Extension of the recruiting period.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Dec 2021
    Due to slow accrual of the trial, and in accordance with the IDMC recommendations, the trial was prematurely stopped.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Low number of patients recruited, the changes in study designs that have occurred throughout the trial, in addition to the premature termination of the study.
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