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NCT05169567 · BASELINE

Baseline characteristics

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer · Source last updated 2026-01-16

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
      182
    2. group Id
      BG001
      value
      186
    3. group Id
      BG002
      value
      368
    units
    Participants
groups
  1. description
    Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
    id
    BG000
    title
    Arm A: Abemaciclib Plus Fulvestrant
  2. description
    Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
    id
    BG001
    title
    Arm B: Placebo Plus Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.15
          value
          58.00
        2. group Id
          BG001
          spread
          12.16
          value
          59.60
        3. group Id
          BG002
          spread
          12.17
          value
          58.80
    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
          180
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          365
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        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
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          278
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          35
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          47
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          283
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          39
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Czechia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Denmark
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Greece
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
      title
      Hungary
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
      title
      Israel
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          27
      title
      Italy
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Mexico
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Poland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      South Korea
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      182
    2. group Id
      BG001
      value
      186
    3. group Id
      BG002
      value
      368
    units
    Participants
groups
  1. description
    Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
    id
    BG000
    title
    Arm A: Abemaciclib Plus Fulvestrant
  2. description
    Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
    id
    BG001
    title
    Arm B: Placebo Plus Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.15
          value
          58.00
        2. group Id
          BG001
          spread
          12.16
          value
          59.60
        3. group Id
          BG002
          spread
          12.17
          value
          58.80
    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
          180
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          365
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        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
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          278
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          35
        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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          47
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          283
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          39
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Czechia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Denmark
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
      title
      France
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Greece
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
      title
      Hungary
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
      title
      Israel
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          27
      title
      Italy
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Mexico
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Poland
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
      title
      South Korea
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All randomized participants.

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

Preserved source evidence · Not medical advice