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    Clinical Trial Results:
    A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients with Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant

    Summary
    EudraCT number
    		 2015-004851-28
    Trial protocol
    		 GB   ES   FR  
    Global end of trial date
    10 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Feb 2020
    First version publication date
    29 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EVG001BC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02970682
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Evgen Pharma PLC
    Sponsor organisation address
    Liverpool Science Park, Innovation Centre 2, 146 Brownlow Hill, Liverpool, United Kingdom, L3 5RF
    Public contact
    Clinical Development Officer, Evgen Pharma PLC, 44 1625466591, enquiries@evgen.com
    Scientific contact
    Clinical Development Officer, Evgen Pharma PLC, 44 1625466591, enquiries@evgen.com
    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
    08 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To determine the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant 2. To determine clinical benefit rate (CBR) (complete response [CR] + partial response [PR] + stable disease [SD]) at 24 weeks using Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1)
    Protection of trial subjects
    Trial subjects were only eligible if they met all 17 inclusion criteria and were excluded for any one of 12 reasons. All patients had to sign an informed consent document, indicating that they understood the purpose of, and procedures required for the study and were willing to participate in the study. A patient could withdraw from the study at any time, and the physician responsible for the patient’s wellbeing could also withdraw the patient at any time for an appropriate medical reason. Withdrawn patients were followed up for safety by the site staff. If a patient prematurely discontinued treatment, the reason for discontinuation was recorded. Safety was assessed by means of clinical examination, vital signs (weight, heart rate, temperature, blood pressure and respiratory rate), performance status, laboratory evaluations (clinical chemistry and haematology), electrocardiograms (ECGs), recording of concurrent illness/therapy and documenting AEs.
    Background therapy
    		 This study was a multi-centre study conducted over a 2-year period. Patients needed to have histologically confirmed ER-positive, HER2-negative, metastatic or locally advanced breast cancer (MBC) with at least 1 site of measurable disease. They previously were to be on either a third generation AI, tamoxifen or fulvestrant and had to have documented evidence of PD immediately prior to entry into this study, but were suitable for continuing the endocrine therapy (ET) they had progressed on according to the treating clinician. Patients continued to receive the same endocrine treatment with the addition of SFX-01.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    22 Dec 2016
    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
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    France: 7
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    27
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was a multi-centre study conducted over a 2-year period. Patients were recruited from those attending sites in the UK, France, Belgium and Spain for treatment of MBC.

    Pre-assignment
    Screening details
    		 The Screening Phase was up to 28 days prior to enrolment. Patients previously were to be on either a third generation AI, tamoxifen or fulvestrant and had to have documented evidence of PD, but were suitable for continuing ET according to the treating clinician. Patients continued to receive the same treatment with the addition of SFX-01

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Aromatase inhibitor plus SFX-01
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sulforadex
    Investigational medicinal product code
    SFX-01
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg SFX-01, one capsule taken twice daily, 12 hours apart after food, preferably within 2 hours of eating. Aromatase inhibitor continued at the same dose prior to entry into the study.

    Arm title
    		 Arm B
    Arm description
    		 Tamoxifen plus SFX-01
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sulforadex
    Investigational medicinal product code
    SFX-01
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg SFX-01, one capsule taken twice daily, 12 hours apart after food, preferably within 2 hours of eating. Tamoxifen continued at the same dose prior to entry into the study.

    Arm title
    		 Arm C
    Arm description
    		 Fulvestrant plus SFX 01
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sulforadex
    Investigational medicinal product code
    SFX-01
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    300mg SFX-01, one capsule taken twice daily, 12 hours apart after food, preferably within 2 hours of eating. Fulvestrant continued at 500mg injected intramuscularly every 28 days.

    Number of subjects in period 1
    		Arm A Arm B Arm C
    Started
    31
    8
    7
    Completed
    7
    4
    1
    Not completed
    24
    4
    6
         Consent withdrawn by subject
    1
    -
    -
         Patient choice: progressive disease & AEs
    2
    -
    -
         Adverse event, non-fatal
    1
    -
    -
         progressive disease
    19
    4
    6
         noncompliance/protocol violation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Aromatase inhibitor plus SFX-01

    Reporting group title
    Arm B
    Reporting group description
    		 Tamoxifen plus SFX-01

    Reporting group title
    Arm C
    Reporting group description
    		 Fulvestrant plus SFX 01

    Reporting group values
    		 Arm A Arm B Arm C Total
    Number of subjects
    		 31 8 7 46
    Age categorical
    Age category at study entry
    Units: Subjects
        Adults (18-64 years)
    		 16 6 5 27
        From 65-84 years
    		 15 2 2 19
    Age continuous
    Age at study entry
    Units: years
        median (full range (min-max))
    		 64 (43 to 82) 55 (45 to 81) 62 (55 to 77) -
    Gender categorical
    Female only
    Units: Subjects
        Female
    		 31 8 7 46
        Male
    		 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) included all patients who received any amount of the IP (SFX 01 or ET).

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all patients who received at least 1 dose of study treatment (SFX-01).

    Subject analysis sets values
    		 FAS Safety
    Number of subjects
    46
    46
    Age categorical
    Age category at study entry
    Units: Subjects
        Adults (18-64 years)
    27
    27
        From 65-84 years
    19
    19
    Age continuous
    Age at study entry
    Units: years
        median (full range (min-max))
    63 (43 to 82)
    63 (43 to 82)
    Gender categorical
    Female only
    Units: Subjects
        Female
    46
    46
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Aromatase inhibitor plus SFX-01

    Reporting group title
    Arm B
    Reporting group description
    		 Tamoxifen plus SFX-01

    Reporting group title
    Arm C
    Reporting group description
    		 Fulvestrant plus SFX 01

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) included all patients who received any amount of the IP (SFX 01 or ET).

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all patients who received at least 1 dose of study treatment (SFX-01).

    Primary: CBR (Clinical Benefit Rate)

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    End point title
    		 CBR (Clinical Benefit Rate) [1]
    End point description
    Primary efficacy endpoint was CBR i.e. the percentage of patients who had a best overall response of confirmed CR or confirmed PR in the first 25 weeks, or who had SD for a minimum of 23 weeks according to RECIST v1.1, based on the investigator’s assessments of radiological data.
    End point type
    Primary
    End point timeframe
    CBR at Week 24 (FAS)
    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 formal stats analysis was pre-specified in the protocol / SAP
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: number of patients
    7
    4
    0
    11
    No statistical analyses for this end point

    Secondary: ORR (Objective Response Rate)

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    End point title
    		 ORR (Objective Response Rate)
    End point description
    Objective response rate (ORR) at 24 weeks using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    ORR at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of patients
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: CR (Complete Response)

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    End point title
    		 CR (Complete Response)
    End point description
    Complete response (CR) at 24 weeks using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    CR (complete response) at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of patients
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Confirmed PR (Partial Response)

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    End point title
    		 Confirmed PR (Partial Response)
    End point description
    Confirmed partial response (PR) at 24 weeks using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    Confirmed partial response (PR) at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of patients
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Unconfirmed PR (Partial Response)

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    End point title
    		 Unconfirmed PR (Partial Response)
    End point description
    Unconfirmed partial response (PR) at 24 weeks using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    Unconfirmed PR (partial response) at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of patients
    0
    1
    1
    2
    No statistical analyses for this end point

    Secondary: SD (Stable Disease)

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    End point title
    		 SD (Stable Disease)
    End point description
    Stable disease (SD) at 24 weeks using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    SD (stable disease) at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of patients
    17
    5
    1
    23
    No statistical analyses for this end point

    Secondary: PD (Progressive Disease)

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    End point title
    		 PD (Progressive Disease)
    End point description
    Progressive Disease (PD) at 24 weeks using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    PD (progressive disease) at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of patients
    13
    2
    4
    19
    No statistical analyses for this end point

    Secondary: Missing

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    End point title
    		 Missing
    End point description
    Missing RECIST v 1.1 tumor assessment response data at 24 weeks.
    End point type
    Secondary
    End point timeframe
    Missing at 24 weeks
    End point values
    		 Arm A Arm B Arm C FAS
    Number of subjects analysed
    31
    8
    7
    46
    Units: Number of Patients
    1
    0
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 week study period plus 30 days after last dose of SFX-01 + ET
    Adverse event reporting additional description
    All AEs were recorded, with details of the duration and the severity of each episode, the action taken with respect to IP, investigator’s evaluation of its relationship to IP and the patient outcome. The intensity (severity of the AE) was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 -

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 46 (21.74%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract stoma complication
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleuritic pain
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 46 (97.83%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 46 (13.04%)
         occurrences all number
    7
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    5
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Platelet count decreased
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Weight decreased
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Dysgeusia
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 46 (19.57%)
         occurrences all number
    13
    Asthenia
         subjects affected / exposed
    8 / 46 (17.39%)
         occurrences all number
    9
    Pain
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    7
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    25 / 46 (54.35%)
         occurrences all number
    28
    Dyspepsia
         subjects affected / exposed
    15 / 46 (32.61%)
         occurrences all number
    17
    Diarrhoea
         subjects affected / exposed
    12 / 46 (26.09%)
         occurrences all number
    12
    Vomiting
         subjects affected / exposed
    10 / 46 (21.74%)
         occurrences all number
    11
    Abdominal pain
         subjects affected / exposed
    7 / 46 (15.22%)
         occurrences all number
    7
    Constipation
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    4
    Abdominal pain upper
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    4
    Flatulence
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    10 / 46 (21.74%)
         occurrences all number
    10
    Arthralgia
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    7
    Pain in extremity
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    5
    Musculoskeletal pain
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 46 (13.04%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2016
    Amendment 01, Version 2.0 Inclusion criterion no. 12 revised to state that no more than 3 prior lines of ET for the MBC
    30 Aug 2016
    Amendment 02, Version 3.0 Added a pregnancy test as study Baseline Visit to the current pregnancy tests at Visit 2 and Visit 11 Amended schedule of events to include the Visit 11 pregnancy test and updated the description of Visit 11 assessments
    07 Oct 2016
    Amendement 03, Version 4.0 Removed tumour biopsy at week 16 Three exploratory objectives (based on: pharmacogenomics, tumour tissue or whole blood samples; liquid biopsy; proteomics) were deleted Made provision for historical paraffin embedded tissue block (or slides derived from this) if available from a previous tumour biopsy to be collected at screening from consented patients Made provision for patients who are receiving clinical benefit to continue to receive SFX-01 after week 24

    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.
    The reported results only present the data from the 24-week main study period. Data from patients who continued SFX-01 + endocrine therapy beyond 24 weeks in the extended use phase of the study are not presented.
    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.

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