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    Clinical Trial Results:
    Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

    Summary
    EudraCT number
    		 2018-002990-24
    Trial protocol
    		 BE   FR   HU   AT   GR   IE   PT   DK   ES   GB   IT  
    Global end of trial date
    22 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2025
    First version publication date
    07 Sep 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RAD1901-308
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03778931
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor Acronym: EMERALD
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A.
    Sponsor organisation address
    Via Tito Speri 10, Pomezia/Rome, Italy, 00071
    Public contact
    Clinical Operations, Radius Pharmaceuticals Inc., +1 617-551-4000, RAD1901-308@radiuspharm.com
    Scientific contact
    Clinical Operations, Radius Pharmaceuticals Inc., +1 617-551-4000, RAD1901-308@radiuspharm.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
    22 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that elacestrant compared with the standard of care (SOC) options of either fulvestrant or an aromatase inhibitor is superior in prolonging progression-free survival based on a blinded imaging review committee (IRC) assessment in postmenopausal women and men with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer, either in participants with estrogen receptor 1 gene (ESR1) mutations (ESR1-mut participants) or in all participants, which includes participants without detectable ESR1 mutations (ESR1-wild-type [ESR1-wt]).
    Protection of trial subjects
    All clinical trial information shall be recorded, processed, handled, and stored in such a way that it can be accurately reported, interpreted and verified; at the same time, the confidentiality of records and of the personal data of the participants shall remain protected in accordance with the Laws and Regulation on personal data protection from time to time applicable such as the EU General Data Protection Regulation 679/2016 and the EU Regulation on clinical trials on medicinal products for human use 536/2014 or the US Health Insurance Portability and Accountability Act regulations (HIPAA), the US Common Rule (45 CFR 46.116). The study protocol defines the appropriate technical and organisational measures that shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss as well as to assure the fulfilment of participants' privacy rights.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 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
    Portugal: 12
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Belgium: 70
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    Greece: 10
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Ireland: 7
    Country: Number of subjects enrolled
    Italy: 35
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    United States: 136
    Country: Number of subjects enrolled
    Israel: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 29
    Country: Number of subjects enrolled
    Argentina: 18
    Country: Number of subjects enrolled
    Australia: 11
    Worldwide total number of subjects
    478
    EEA total number of subjects
    246
    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)
    263
    From 65 to 84 years
    213
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 All deaths regardless of causality are reported as 'number of deaths (all causes)' in the Serious Adverse Events table. Only deaths leading to study discontinuation are reported in the Subject Disposition.

    Pre-assignment
    Screening details
    		 This study screened 695 participants who granted informed consent for participation, and randomized 478 participants to treatment with either elacestrant or SOC.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elacestrant
    Arm description
    		 Participants in Arm 1 will receive elacestrant. Elacestrant: 400 milligrams/day once daily oral dosing
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elacestrant
    Investigational medicinal product code
    Other name
    RAD1901; ORSERDU
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once per day

    Arm title
    		 Standard of Care (SoC)
    Arm description
    		 Participants in Arm 2 will receive investigator’s choice of one of the SOC drugs (fulvestrant, anastrozole, letrozole, or exemestane). SOC: • Fulvestrant: 500 milligrams administered intramuscularly into the buttocks as two 5-millilitre injections on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 and Day 1 of every subsequent 28-day cycle • Anastrozole 1 milligram/day on a continuous dosing schedule • Letrozole: 2.5 milligrams/day on a continuous dosing schedule • Exemestane: 25 milligrams/day on a continuous dosing schedule
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fulvestrant
    Investigational medicinal product code
    Other name
    Faslodex
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 and Day 1 of every subsequent 28-day cycle

    Investigational medicinal product name
    Anastrozole
    Investigational medicinal product code
    Other name
    Arimidex
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once per day

    Investigational medicinal product name
    Letrozole
    Investigational medicinal product code
    Other name
    Femara
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once per day

    Investigational medicinal product name
    Exemestane
    Investigational medicinal product code
    Other name
    Aromasin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once per day

    Number of subjects in period 1
    		Elacestrant Standard of Care (SoC)
    Started
    239
    239
    Intent-to-Treat Population
    239
    239
    Safety Population
    237
    230
    Completed
    152
    130
    Not completed
    87
    109
         Physician decision
    1
    3
         Consent withdrawn by subject
    12
    25
         Participant Noncompliance
    1
    1
         Death
    69
    79
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Elacestrant
    Reporting group description
    		 Participants in Arm 1 will receive elacestrant. Elacestrant: 400 milligrams/day once daily oral dosing

    Reporting group title
    Standard of Care (SoC)
    Reporting group description
    		 Participants in Arm 2 will receive investigator’s choice of one of the SOC drugs (fulvestrant, anastrozole, letrozole, or exemestane). SOC: • Fulvestrant: 500 milligrams administered intramuscularly into the buttocks as two 5-millilitre injections on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 and Day 1 of every subsequent 28-day cycle • Anastrozole 1 milligram/day on a continuous dosing schedule • Letrozole: 2.5 milligrams/day on a continuous dosing schedule • Exemestane: 25 milligrams/day on a continuous dosing schedule

    Reporting group values
    		 Elacestrant Standard of Care (SoC) Total
    Number of subjects
    		 239 239 478
    Age categorical
    Units: Subjects
        <18 years
    		 0 0 0
        Between 18 and 65 years
    		 135 128 263
        >65 years
    		 104 111 215
    Gender categorical
    Units: Subjects
        Female
    		 233 238 471
        Male
    		 6 1 7
    Ethnicity (NIH/OMB)
    NIH/OMB = National Institutes of Health/Office of Management and Budget
    Units: Subjects
        Hispanic or Latino
    		 19 18 37
        Not Hispanic or Latino
    		 194 191 385
        Unknown or Not Reported
    		 26 30 56
    Eastern Cooperative Oncology Group Performance Status
    Participants were graded on a scale from 0 to 5, where 5 was worst: 0. Normal activity. Fully active, able to carry on all pre-disease performance w/o restriction 1. Symptoms, but ambulatory. Restricted in strenuous activity, ambulatory and able to carry out light work 2. In bed <50% of time. Ambulatory, capable of all self-care, unable to carry out any work activities 3. In bed >50% of time. Capable of limited self-care 4. 100% bedridden. Completely disabled. Cannot carry out any self-care. Confined to bed or chair 5. Dead
    Units: Subjects
        0: Fully active, able to carry on all pre-disease
    		 143 135 278
        1: Restricted in physically strenuous activity
    		 96 103 199
        2: Ambulatory but unable to carry out any work
    		 0 1 1
    Height
    Data was not collected for five participants
    Units: centimetres
        arithmetic mean (standard deviation)
    		 ( ) ( ) -
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 72.70 ( 16.093 ) 72.39 ( 16.390 ) -
    Body Mass Index
    Data was not collected for five participants
    Units: kilograms/metre squared
        arithmetic mean (standard deviation)
    		 ( ) ( ) -
    Subject analysis sets

    Subject analysis set title
    Elacestrant: Baseline Characteristics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participant data were missing for this baseline measurement.

    Subject analysis set title
    Standard of Care (SoC): Baseline Characteristics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participant data were missing for this baseline measurement.

    Subject analysis sets values
    		 Elacestrant: Baseline Characteristics Standard of Care (SoC): Baseline Characteristics
    Number of subjects
    236
    237
    Age categorical
    Units: Subjects
        <18 years
        Between 18 and 65 years
        >65 years
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnicity (NIH/OMB)
    NIH/OMB = National Institutes of Health/Office of Management and Budget
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported
    Eastern Cooperative Oncology Group Performance Status
    Participants were graded on a scale from 0 to 5, where 5 was worst: 0. Normal activity. Fully active, able to carry on all pre-disease performance w/o restriction 1. Symptoms, but ambulatory. Restricted in strenuous activity, ambulatory and able to carry out light work 2. In bed <50% of time. Ambulatory, capable of all self-care, unable to carry out any work activities 3. In bed >50% of time. Capable of limited self-care 4. 100% bedridden. Completely disabled. Cannot carry out any self-care. Confined to bed or chair 5. Dead
    Units: Subjects
        0: Fully active, able to carry on all pre-disease
        1: Restricted in physically strenuous activity
        2: Ambulatory but unable to carry out any work
    Height
    Data was not collected for five participants
    Units: centimetres
        arithmetic mean (standard deviation)
    162.27 ( 7.860 )
    160.97 ( 7.149 )
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    ( )
    ( )
    Body Mass Index
    Data was not collected for five participants
    Units: kilograms/metre squared
        arithmetic mean (standard deviation)
    27.58 ( 5.494 )
    27.92 ( 5.853 )

    End points

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    End points reporting groups
    Reporting group title
    Elacestrant
    Reporting group description
    		 Participants in Arm 1 will receive elacestrant. Elacestrant: 400 milligrams/day once daily oral dosing

    Reporting group title
    Standard of Care (SoC)
    Reporting group description
    		 Participants in Arm 2 will receive investigator’s choice of one of the SOC drugs (fulvestrant, anastrozole, letrozole, or exemestane). SOC: • Fulvestrant: 500 milligrams administered intramuscularly into the buttocks as two 5-millilitre injections on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 and Day 1 of every subsequent 28-day cycle • Anastrozole 1 milligram/day on a continuous dosing schedule • Letrozole: 2.5 milligrams/day on a continuous dosing schedule • Exemestane: 25 milligrams/day on a continuous dosing schedule

    Subject analysis set title
    Elacestrant: Baseline Characteristics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participant data were missing for this baseline measurement.

    Subject analysis set title
    Standard of Care (SoC): Baseline Characteristics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participant data were missing for this baseline measurement.

    Primary: Progression-free Survival in ESR1-mut Participants

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    End point title
    		 Progression-free Survival in ESR1-mut Participants
    End point description
    Progression-free survival based on blinded IRC assessment in ESR1-mut participants defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    End point type
    Primary
    End point timeframe
    From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
    End point values
    		 Elacestrant Standard of Care (SoC)
    Number of subjects analysed
    115
    113
    Units: months
        median (confidence interval 95%)
    3.78 (2.17 to 7.26)
    1.87 (1.87 to 2.14)
    Statistical analysis title
    		 Progression-free Survival in ESR1-mut Participants
    Statistical analysis description
    The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes versus no) and presence of visceral metastases (yes versus no); the confidence interval calculated using a profile likelihood approach.
    Comparison groups
    Elacestrant v Standard of Care (SoC)
    Number of subjects included in analysis
    228
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0005 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.546
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.387
         upper limit
    		 0.768
    Notes
    [1] - The p-value was generated by using a two-sided stratified log-rank test.

    Primary: Progression-free Survival in All Participants

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    End point title
    		 Progression-free Survival in All Participants
    End point description
    Progression-free survival based on blinded IRC assessment in all (ESR1-mut and ESR1-wt) participants.
    End point type
    Primary
    End point timeframe
    From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
    End point values
    		 Elacestrant Standard of Care (SoC)
    Number of subjects analysed
    239
    239
    Units: months
        median (confidence interval 95%)
    2.79 (1.94 to 3.78)
    1.91 (1.87 to 2.10)
    Statistical analysis title
    		 Progression-free Survival in All Participants
    Statistical analysis description
    The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes versus no) and presence of visceral metastases (yes versus no); the confidence interval calculated using a profile likelihood approach.
    Comparison groups
    Elacestrant v Standard of Care (SoC)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0018 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.697
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.552
         upper limit
    		 0.88
    Notes
    [2] - The p-value was generated by using a two-sided stratified log-rank test.

    Secondary: Overall Survival in ESR1-mut Participants

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    End point title
    		 Overall Survival in ESR1-mut Participants
    End point description
    Overall survival in ESR1-mut participants, where overall survival is defined as the length of time from randomization until the date of death from any cause. '9999' = not calculable (insufficient number of participants with events).
    End point type
    Secondary
    End point timeframe
    From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
    End point values
    		 Elacestrant Standard of Care (SoC)
    Number of subjects analysed
    115
    113
    Units: months
        median (confidence interval 95%)
    9999 (18.60 to 9999)
    16.95 (14.00 to 9999)
    Statistical analysis title
    		 Overall Survival in ESR1-mut Participants
    Statistical analysis description
    The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes versus no) and presence of visceral metastases (yes versus no); the confidence interval calculated using a profile likelihood approach.
    Comparison groups
    Elacestrant v Standard of Care (SoC)
    Number of subjects included in analysis
    228
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0325 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard Ratio
    Point estimate
    0.592
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.361
         upper limit
    		 0.958
    Notes
    [3] - The p-value was generated by using a two-sided stratified log-rank test.

    Secondary: Overall Survival in All Participants

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    End point title
    		 Overall Survival in All Participants
    End point description
    Overall survival in all (ESR1-mut and ESR1-wt) participants. '9999' = not calculable (insufficient number of participants with events).
    End point type
    Secondary
    End point timeframe
    From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
    End point values
    		 Elacestrant Standard of Care (SoC)
    Number of subjects analysed
    239
    239
    Units: months
        median (confidence interval 95%)
    9999 (19.29 to 9999)
    9999 (15.80 to 9999)
    Statistical analysis title
    		 Overall Survival in All Participants
    Statistical analysis description
    Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut versus ESR1-wt), prior treatment with fulvestrant (yes versus no) and presence of visceral metastases (yes versus no).
    Comparison groups
    Elacestrant v Standard of Care (SoC)
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0697 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard Ratio
    Point estimate
    0.742
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.536
         upper limit
    		 1.025
    Notes
    [4] - The p-value was generated by using a two-sided stratified log-rank test.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 months
    Adverse event reporting additional description
    The 'number of deaths (all causes)', progression-free survival, and overall survival were assessed with the Intention-to-Treat Population, which consisted of all randomized participants. Adverse Events (Serious and Other) reporting reflects the Safety Population, which consisted of all participants who received at least 1 dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Elacestrant
    Reporting group description
    		 Participants in Arm 1 will receive elacestrant. Elacestrant: 400 milligrams/day once daily oral dosing

    Reporting group title
    Standard of Care (SoC)
    Reporting group description
    		 Participants in Arm 2 will receive investigator’s choice of one of the SOC drugs (fulvestrant, anastrozole, letrozole, or exemestane). SOC: • Fulvestrant: 500 milligrams administered intramuscularly into the buttocks as two 5-millilitre injections on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 and Day 1 of every subsequent 28-day cycle • Anastrozole 1 milligram/day on a continuous dosing schedule • Letrozole: 2.5 milligrams/day on a continuous dosing schedule • Exemestane: 25 milligrams/day on a continuous dosing schedule

    Serious adverse events
    		 Elacestrant Standard of Care (SoC)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 237 (12.24%)
    25 / 230 (10.87%)
         number of deaths (all causes)
    70
    80
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm of pleura
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve paralysis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Meningeal disorder
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Antiphospholipid syndrome
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 237 (0.00%)
    2 / 230 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 237 (1.27%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 237 (0.84%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Device related sepsis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 237 (0.42%)
    3 / 230 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 237 (0.00%)
    2 / 230 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 237 (0.42%)
    0 / 230 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 237 (0.42%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 237 (0.00%)
    1 / 230 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Elacestrant Standard of Care (SoC)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    215 / 237 (90.72%)
    195 / 230 (84.78%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    31 / 237 (13.08%)
    29 / 230 (12.61%)
         occurrences all number
    40
    33
    Alanine aminotransferase increased
         subjects affected / exposed
    22 / 237 (9.28%)
    24 / 230 (10.43%)
         occurrences all number
    29
    29
    Blood alkaline phosphatase increased
         subjects affected / exposed
    15 / 237 (6.33%)
    17 / 230 (7.39%)
         occurrences all number
    18
    19
    Vascular disorders
    Hot flush
         subjects affected / exposed
    27 / 237 (11.39%)
    19 / 230 (8.26%)
         occurrences all number
    30
    27
    Hypertension
         subjects affected / exposed
    9 / 237 (3.80%)
    12 / 230 (5.22%)
         occurrences all number
    14
    13
    Nervous system disorders
    Headache
         subjects affected / exposed
    29 / 237 (12.24%)
    26 / 230 (11.30%)
         occurrences all number
    39
    34
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    45 / 237 (18.99%)
    44 / 230 (19.13%)
         occurrences all number
    50
    54
    Injection site pain
         subjects affected / exposed
    0 / 237 (0.00%)
    14 / 230 (6.09%)
         occurrences all number
    0
    16
    Asthenia
         subjects affected / exposed
    21 / 237 (8.86%)
    19 / 230 (8.26%)
         occurrences all number
    28
    24
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    22 / 237 (9.28%)
    17 / 230 (7.39%)
         occurrences all number
    35
    36
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    83 / 237 (35.02%)
    44 / 230 (19.13%)
         occurrences all number
    121
    51
    Vomiting
         subjects affected / exposed
    45 / 237 (18.99%)
    20 / 230 (8.70%)
         occurrences all number
    60
    27
    Diarrhoea
         subjects affected / exposed
    33 / 237 (13.92%)
    22 / 230 (9.57%)
         occurrences all number
    48
    24
    Constipation
         subjects affected / exposed
    29 / 237 (12.24%)
    15 / 230 (6.52%)
         occurrences all number
    34
    17
    Dyspepsia
         subjects affected / exposed
    24 / 237 (10.13%)
    6 / 230 (2.61%)
         occurrences all number
    25
    9
    Abdominal pain
         subjects affected / exposed
    15 / 237 (6.33%)
    13 / 230 (5.65%)
         occurrences all number
    16
    13
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    18 / 237 (7.59%)
    16 / 230 (6.96%)
         occurrences all number
    18
    17
    Cough
         subjects affected / exposed
    15 / 237 (6.33%)
    12 / 230 (5.22%)
         occurrences all number
    16
    12
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    18 / 237 (7.59%)
    11 / 230 (4.78%)
         occurrences all number
    19
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    34 / 237 (14.35%)
    37 / 230 (16.09%)
         occurrences all number
    42
    44
    Back pain
         subjects affected / exposed
    32 / 237 (13.50%)
    22 / 230 (9.57%)
         occurrences all number
    39
    22
    Pain in extremity
         subjects affected / exposed
    18 / 237 (7.59%)
    14 / 230 (6.09%)
         occurrences all number
    21
    16
    Bone pain
         subjects affected / exposed
    14 / 237 (5.91%)
    15 / 230 (6.52%)
         occurrences all number
    20
    16
    Musculoskeletal chest pain
         subjects affected / exposed
    14 / 237 (5.91%)
    7 / 230 (3.04%)
         occurrences all number
    16
    7
    Musculoskeletal pain
         subjects affected / exposed
    11 / 237 (4.64%)
    13 / 230 (5.65%)
         occurrences all number
    16
    19
    Myalgia
         subjects affected / exposed
    11 / 237 (4.64%)
    17 / 230 (7.39%)
         occurrences all number
    15
    19
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    16 / 237 (6.75%)
    12 / 230 (5.22%)
         occurrences all number
    19
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    35 / 237 (14.77%)
    22 / 230 (9.57%)
         occurrences all number
    42
    27
    Hyperglycaemia
         subjects affected / exposed
    6 / 237 (2.53%)
    12 / 230 (5.22%)
         occurrences all number
    8
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2019
    - Added an interim futility analysis at 70% enrollment - Added a study steering committee to provide guidance on protocol development, implementation, investigator selection, and recruitment strategies

    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.

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