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NCT04975308 · FLOW

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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.

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
    FG000
    title
    Arm A: 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
    FG001
    title
    Arm B: 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
    FG002
    title
    Arm C: Imlunestrant + Abemaciclib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        6
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        75
      type
      On study treatment (Ongoing)
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Protocol Deviation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        331
      2. group Id
        FG001
        num Subjects
        330
      3. group Id
        FG002
        num Subjects
        213
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        331
      2. comment
        For analyses between Arm A and Arm B, the study was planned to analyze Arm B as a whole, regardless of whether the participants received exemestane or fulvestrant as the Investigator's Choice of Endocrine Therapy.
        group Id
        FG001
        num Subjects
        330
      3. group Id
        FG002
        num Subjects
        0
      comment
      All participants who were randomly assigned to either Arm A or Arm B.
      type
      Analysis Population for the Comparison Between Arm A and Arm B
    3. achievements
      1. group Id
        FG000
        num Subjects
        213
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        213
      comment
      For analyses between arm C and arm A, the study was planned to include participants who were randomized to these arms concurrently.
      type
      Analysis Population for the Comparison Between Arm C and Arm A
    4. achievements
      1. group Id
        FG000
        num Subjects
        138
      2. group Id
        FG001
        num Subjects
        118
      3. group Id
        FG002
        num Subjects
        0
      type
      Estrogen Receptor 1 (ESR1) Mutation-Detected Population for Comparison Between Arm A and Arm B
    5. achievements
      1. group Id
        FG000
        num Subjects
        326
      2. group Id
        FG001
        num Subjects
        324
      3. group Id
        FG002
        num Subjects
        209
      type
      Received at Least 1 Dose of Study Drug
    6. achievements
      1. comment
        One participant assigned to Arm C received Imlunestrant alone (i.e., did not receive abemaciclib) and was therefore included in Arm A for safety analyses.
        group Id
        FG000
        num Subjects
        327
      2. comment
        Investigator's Choice of Endocrine Therapy: * exemestane = 32 * fulvestrant = 292
        group Id
        FG001
        num Subjects
        324
      3. group Id
        FG002
        num Subjects
        208
      comment
      All randomised participants who received at least 1 dose of study drug. Participants were analyzed according to the study treatment they actually received.
      type
      Safety Analysis Population
    7. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        264
      3. group Id
        FG002
        num Subjects
        117
      comment
      Participants with progressive disease or death were considered study completers.
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        66
      3. group Id
        FG002
        num Subjects
        96
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was initially planned with participants randomized 1:1 to either arm A or arm B. Following a protocol amendment, arm C was added later, after randomization to arms A and B had already begun.
Complete source fields
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
    FG000
    title
    Arm A: 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
    FG001
    title
    Arm B: 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
    FG002
    title
    Arm C: Imlunestrant + Abemaciclib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        6
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        75
      type
      On study treatment (Ongoing)
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Protocol Deviation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        331
      2. group Id
        FG001
        num Subjects
        330
      3. group Id
        FG002
        num Subjects
        213
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        331
      2. comment
        For analyses between Arm A and Arm B, the study was planned to analyze Arm B as a whole, regardless of whether the participants received exemestane or fulvestrant as the Investigator's Choice of Endocrine Therapy.
        group Id
        FG001
        num Subjects
        330
      3. group Id
        FG002
        num Subjects
        0
      comment
      All participants who were randomly assigned to either Arm A or Arm B.
      type
      Analysis Population for the Comparison Between Arm A and Arm B
    3. achievements
      1. group Id
        FG000
        num Subjects
        213
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        213
      comment
      For analyses between arm C and arm A, the study was planned to include participants who were randomized to these arms concurrently.
      type
      Analysis Population for the Comparison Between Arm C and Arm A
    4. achievements
      1. group Id
        FG000
        num Subjects
        138
      2. group Id
        FG001
        num Subjects
        118
      3. group Id
        FG002
        num Subjects
        0
      type
      Estrogen Receptor 1 (ESR1) Mutation-Detected Population for Comparison Between Arm A and Arm B
    5. achievements
      1. group Id
        FG000
        num Subjects
        326
      2. group Id
        FG001
        num Subjects
        324
      3. group Id
        FG002
        num Subjects
        209
      type
      Received at Least 1 Dose of Study Drug
    6. achievements
      1. comment
        One participant assigned to Arm C received Imlunestrant alone (i.e., did not receive abemaciclib) and was therefore included in Arm A for safety analyses.
        group Id
        FG000
        num Subjects
        327
      2. comment
        Investigator's Choice of Endocrine Therapy: * exemestane = 32 * fulvestrant = 292
        group Id
        FG001
        num Subjects
        324
      3. group Id
        FG002
        num Subjects
        208
      comment
      All randomised participants who received at least 1 dose of study drug. Participants were analyzed according to the study treatment they actually received.
      type
      Safety Analysis Population
    7. achievements
      1. group Id
        FG000
        num Subjects
        246
      2. group Id
        FG001
        num Subjects
        264
      3. group Id
        FG002
        num Subjects
        117
      comment
      Participants with progressive disease or death were considered study completers.
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        66
      3. group Id
        FG002
        num Subjects
        96
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was initially planned with participants randomized 1:1 to either arm A or arm B. Following a protocol amendment, arm C was added later, after randomization to arms A and B had already begun.

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Preserved source evidence · Not medical advice