Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04975308 · BASELINE

Baseline characteristics

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer · Source last updated 2026-07-22

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
      331
    2. group Id
      BG001
      value
      330
    3. group Id
      BG002
      value
      213
    4. group Id
      BG003
      value
      874
    units
    Participants
groups
  1. description
    Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
    id
    BG000
    title
    Imlunestrant
  2. description
    Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
    id
    BG001
    title
    Investigator's Choice of Endocrine Therapy
  3. description
    Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
    id
    BG002
    title
    Imlunestrant + Abemaciclib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          60.4
        2. group Id
          BG001
          spread
          12.0
          value
          60.8
        3. group Id
          BG002
          spread
          11.1
          value
          61.9
        4. group Id
          BG003
          spread
          11.6
          value
          60.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          327
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          211
        4. group Id
          BG003
          value
          867
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          196
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          216
        3. group Id
          BG002
          value
          148
        4. group Id
          BG003
          value
          582
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          96
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          42
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          260
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          111
        4. group Id
          BG003
          value
          488
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          46
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          323
        title
        Detected
      2. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          146
        4. group Id
          BG003
          value
          551
        title
        Not detected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Estrogen Receptor 1 (ESR1)-Mutation
    unit Of Measure
    Participants
population Description
All randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      331
    2. group Id
      BG001
      value
      330
    3. group Id
      BG002
      value
      213
    4. group Id
      BG003
      value
      874
    units
    Participants
groups
  1. description
    Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
    id
    BG000
    title
    Imlunestrant
  2. description
    Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
    id
    BG001
    title
    Investigator's Choice of Endocrine Therapy
  3. description
    Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
    id
    BG002
    title
    Imlunestrant + Abemaciclib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          60.4
        2. group Id
          BG001
          spread
          12.0
          value
          60.8
        3. group Id
          BG002
          spread
          11.1
          value
          61.9
        4. group Id
          BG003
          spread
          11.6
          value
          60.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          327
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          211
        4. group Id
          BG003
          value
          867
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          196
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          216
        3. group Id
          BG002
          value
          148
        4. group Id
          BG003
          value
          582
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          96
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          42
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          260
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          111
        4. group Id
          BG003
          value
          488
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          46
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          323
        title
        Detected
      2. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          146
        4. group Id
          BG003
          value
          551
        title
        Not detected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Estrogen Receptor 1 (ESR1)-Mutation
    unit Of Measure
    Participants
population Description
All randomized participants.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice