Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Presurgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide (ODM-201)

    Summary
    EudraCT number
    		 2016-004151-79
    Trial protocol
    		 DE  
    Global end of trial date
    13 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2020
    First version publication date
    11 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TRIO030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03004534
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Translational Research In Oncology (TRIO)
    Sponsor organisation address
    Suite 1100 9925-109 Street , Edmonton, Canada, T5K 2J8
    Public contact
    Project Management, Translational Research In Oncology (TRIO), 33 158 10 09 09, 030@trioncology.org
    Scientific contact
    Project Management, Translational Research In Oncology (TRIO), 33 158 10 09 09, 030@trioncology.org
    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
    13 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify the molecular alterations that occur in human breast cancer (BC) tissue, following short-term exposure to darolutamide in female subjects with early breast cancer (EBC).
    Protection of trial subjects
    Regular assessment and monitoring of adverse events (AEs) is required from Patient Informed Consent Form (PICF) signature, throughout the protocol treatment period and at least up until surgery or BC pre-NAST biopsy if patient will receive NAST. Toxicity was assessed utilizing the National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v4.03. For toxicities not specifically listed in the NCI CTCAE, the following grading will apply for assessing severity:  Grade 1: Mild  Grade 2: Moderate  Grade 3: Severe  Grade 4: Life-threatening  Grade 5: Death related to AE Patients will be instructed to notify their physician immediately for any and all AEs. Doses of protocol treatment may be modified (delayed or reduced) in case of clinically significant toxicities that are considered by the Investigator to be related to protocol treatment, according to the protocol. Assessment of causality (chronology, confounding factors, concomitant medications, diagnostic tests, and previous experience with the protocol treatment) should be conducted by the Investigator prior to dose modification and/or delay whenever possible.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    36
    EEA total number of subjects
    7
    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)
    20
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were registered in the study once the Patient Informed Consent Form (PICF) signature was received. Pre-treatment tumor samples were collected at screening. After all screening procedures, and confirmation of eligibility, patients were enrolled and started oral intake of darolutamide.

    Pre-assignment
    Screening details
    		 The screening period starts with registration (which is the time of informed consent signature) and ends when the patient is enrolled (following eligibility central review and confirmation by TRIO) or screen failed.

    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
    This was an open label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Triple Negative Breast Cancer (TNBC)
    Arm description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.
    Arm type
    		 Breast Cancer Sub-type

    Investigational medicinal product name
    Darolutamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Arm title
    		 HER2 Positive
    Arm description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.
    Arm type
    		 Breast Cancer Sub-type

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 HR+/HER2 Negative
    Arm description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.
    Arm type
    		 Breast Cancer Sub-type

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Triple Negative Breast Cancer (TNBC) HER2 Positive HR+/HER2 Negative
    Started
    7
    9
    20
    Completed
    7
    9
    20

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Triple Negative Breast Cancer (TNBC)
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group title
    HER2 Positive
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group title
    HR+/HER2 Negative
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group values
    		 Triple Negative Breast Cancer (TNBC) HER2 Positive HR+/HER2 Negative Total
    Number of subjects
    		 7 9 20 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 4 6 10 20
        From 65-84 years
    		 3 3 10 16
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.3 ± 17.7 61.8 ± 11.7 61.0 ± 8.1 -
    Gender categorical
    Units: Subjects
        Female
    		 7 9 20 36
        Male
    		 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Triple Negative Breast Cancer (TNBC)
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group title
    HER2 Positive
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group title
    HR+/HER2 Negative
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Primary: Breast Cancer Tissue Androgen Receptor Gene Expression

    		 Close Top of page
    End point title
    		 Breast Cancer Tissue Androgen Receptor Gene Expression [1]
    End point description
    AR levels were measured in patients following darolutamide treatment and patients were characterized into 3 groups, AR down regulated, AR up-regulated and AR unchanged. There was a stronger concordance between IHC measurements and transcript level of AR versus protein AR measurements.
    End point type
    Primary
    End point timeframe
    Assessment performed once all patients have completed the trial as per protocol (all patients have completed their End of Study visit).
    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: The grouping into 3 groups based on the AR level changes induced by darolutamide (up, down, no change) was using an arbitrary 1.2 fold cut-off in order to make at least 3 different groups for data analysis by ANOVA. No statistical analysis was conducted to compare the number of patients with the different AR level changes within each breast cancer subtype. This decision is due to the small sample size that prevented statistical analysis.
    End point values
    		 Triple Negative Breast Cancer (TNBC) HER2 Positive HR+/HER2 Negative
    Number of subjects analysed
    7
    8 [2]
    19 [3]
    Units: Patients
        Androgen Receptor - Up
    1
    3
    3
        Androgen Recepto - No Change
    2
    2
    7
        Androgen Receptor - Down
    4
    3
    9
    Notes
    [2] - Assay from one patient was not obtained.
    [3] - Assay from one patient was not obtained.
    No statistical analyses for this end point

    Primary: Breast Cancer Tissue Androgen Receptor Protein Level

    		 Close Top of page
    End point title
    		 Breast Cancer Tissue Androgen Receptor Protein Level [4]
    End point description
    AR levels were measured in patients following darolutamide treatment and patients were characterized into 3 groups, AR down regulated, AR up-regulated and AR unchanged. There was a stronger concordance between IHC measurements and transcript level of AR versus protein AR measurements.
    End point type
    Primary
    End point timeframe
    Assessment performed once all patients have completed the trial as per protocol (all patients have completed their End of Study visit).
    Notes
    [4] - 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: The grouping into 3 groups based on the AR level changes induced by darolutamide (up, down, no change) was using an arbitrary 1.2 fold cut-off in order to make at least 3 different groups for data analysis by ANOVA. No statistical analysis was conducted to compare the number of patients with the different AR level changes within each breast cancer subtype. This decision is due to the small sample size that prevented statistical analysis.
    End point values
    		 Triple Negative Breast Cancer (TNBC) HER2 Positive HR+/HER2 Negative
    Number of subjects analysed
    7
    8 [5]
    19 [6]
    Units: Patients
        Androgen Receptor - Up
    1
    3
    8
        Andorgen Receptor - No Change
    6
    3
    2
        Andorgen Receptor - Down
    0
    2
    10
    Notes
    [5] - Assay from one patient was not obtained.
    [6] - Assay from one patient was not obtained.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Regular assessment and monitoring of adverse events (AEs) is required from informed consent signature, throughout the protocol treatment period, and at least up until surgery, or breast cancer pre-NAST biopsy (if the patient received NAST).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Triple Negative Breast Cancer (TNBC)
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group title
    HER2 Positive
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Reporting group title
    HR+/HER2 Negative
    Reporting group description
    		 There were a total of 3 cohorts, organized by breast cancer sub-types: - HR+/HER2 negative - HER2 positive - Triple-negative All patients received darolutamide at a dose of 600 mg (2 × 300 mg tablets) twice daily (b.i.d.) by mouth, corresponding to a daily dose of 1200 mg.

    Serious adverse events
    		 Triple Negative Breast Cancer (TNBC) HER2 Positive HR+/HER2 Negative
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Triple Negative Breast Cancer (TNBC) HER2 Positive HR+/HER2 Negative
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    6 / 9 (66.67%)
    15 / 20 (75.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 7 (28.57%)
    4 / 9 (44.44%)
    2 / 20 (10.00%)
         occurrences all number
    2
    4
    2
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Breast discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Breast oedema
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Vulval disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Blood creatinine increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    Seroma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    2 / 20 (10.00%)
         occurrences all number
    0
    1
    2
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    0
    2
    Flatulence
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Gingival bleeding
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash pruritic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Endocrine disorders
    Thyroid pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Limb discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Eyelid infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2018
    -Wording modified to allow patients candidates for neoadjuvant therapy to participate on the study, as long as patients and Investigators were willing to start such therapy once treatment with darolutamide was completed and a biopsy would be undergone prior to starting neoadjuvant therapy. -Sections updated as per safety data from Amendment 1 to Investigator’s Brochure version 3.0, dated 22-Dec-2017. -Allowance of 2 cores for screening samples if 3 were not feasible (i.e. allow collection of 1 FFT core if not possible to provide 2 FFT cores) -Allowance of a minimum of 8 evaluable patients per cohort. -Wording added to clarify that patients enrolled but never treated would be discontinued from study. -Potential reasons for the premature termination of the study by the sponsor added. -Inclusion criterion modified to allow patients with T1 ≥ 1.0 cm (instead of ≥ 1.5 cm) -Modifications done on exclusion criteria related to previous or concurrent anti-cancer treatments. -Conditions required to consider vasectomised male partner as a highly effective contraceptive method added. -Wording added to allow Pre-surgery visit to take place the same day as BC surgery/pre-NAST biopsy. -Wording modified to request that laboratory safety tests be available and reviewed in the Pre-surgery visit before surgerywas performed. -Wording modified to perform interim review of data at given time points depending on the recruitment, for example once 20, around 35 and once all patients had been enrolled and undergone the EoS as per protocol.

    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.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Apr 29 22:51:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA