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NCT03778931 · BASELINE

Baseline characteristics

Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer · Source last updated 2025-09-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      239
    2. group Id
      BG001
      value
      239
    3. group Id
      BG002
      value
      478
    units
    Participants
groups
  1. description
    Participants in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing
    id
    BG000
    title
    Elacestrant
  2. description
    Participants in Arm 2 will receive Investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: * Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle * Anastrozole 1 mg/day on a continuous dosing schedule * Letrozole: 2.5 mg/day on a continuous dosing schedule * Exemestane: 25 mg/day on a continuous dosing schedule
    id
    BG001
    title
    Standard of Care (SoC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          263
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          215
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          471
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          194
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          385
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          56
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.860
          value
          162.27
        2. group Id
          BG001
          spread
          7.149
          value
          160.97
        3. group Id
          BG002
          spread
          7.532
          value
          161.62
      denoms
      1. counts
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          237
        3. group Id
          BG002
          value
          473
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Data was not collected for five participants
    title
    Height
    unit Of Measure
    cm
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.093
          value
          72.70
        2. group Id
          BG001
          spread
          16.390
          value
          72.39
        3. group Id
          BG002
          spread
          16.226
          value
          72.55
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.494
          value
          27.58
        2. group Id
          BG001
          spread
          5.853
          value
          27.92
        3. group Id
          BG002
          spread
          5.673
          value
          27.75
      denoms
      1. counts
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          237
        3. group Id
          BG002
          value
          473
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Data was not collected for five participants
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          278
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
      title
      0: Fully active, able to carry on all pre-disease performance without restriction
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          199
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
      title
      1: Restricted in physically strenuous activity but ambulatory & can carry out light, sedentary work
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
      title
      2: Ambulatory and capable of all selfcare but unable to carry out any work activities
    description
    Participants were graded on a scale from 0 to 5, where 5 was the worst: 0\. Normal activity. Fully active, able to carry on all pre-disease performance without 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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      239
    2. group Id
      BG001
      value
      239
    3. group Id
      BG002
      value
      478
    units
    Participants
groups
  1. description
    Participants in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing
    id
    BG000
    title
    Elacestrant
  2. description
    Participants in Arm 2 will receive Investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: * Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle * Anastrozole 1 mg/day on a continuous dosing schedule * Letrozole: 2.5 mg/day on a continuous dosing schedule * Exemestane: 25 mg/day on a continuous dosing schedule
    id
    BG001
    title
    Standard of Care (SoC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          263
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          215
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          471
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          194
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          385
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          56
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.860
          value
          162.27
        2. group Id
          BG001
          spread
          7.149
          value
          160.97
        3. group Id
          BG002
          spread
          7.532
          value
          161.62
      denoms
      1. counts
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          237
        3. group Id
          BG002
          value
          473
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Data was not collected for five participants
    title
    Height
    unit Of Measure
    cm
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.093
          value
          72.70
        2. group Id
          BG001
          spread
          16.390
          value
          72.39
        3. group Id
          BG002
          spread
          16.226
          value
          72.55
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.494
          value
          27.58
        2. group Id
          BG001
          spread
          5.853
          value
          27.92
        3. group Id
          BG002
          spread
          5.673
          value
          27.75
      denoms
      1. counts
        1. group Id
          BG000
          value
          236
        2. group Id
          BG001
          value
          237
        3. group Id
          BG002
          value
          473
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Data was not collected for five participants
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          278
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
      title
      0: Fully active, able to carry on all pre-disease performance without restriction
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          199
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
      title
      1: Restricted in physically strenuous activity but ambulatory & can carry out light, sedentary work
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          239
        3. group Id
          BG002
          value
          478
        units
        Participants
      title
      2: Ambulatory and capable of all selfcare but unable to carry out any work activities
    description
    Participants were graded on a scale from 0 to 5, where 5 was the worst: 0\. Normal activity. Fully active, able to carry on all pre-disease performance without 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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice