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NCT05169567 · FLOW

Participant flow

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.

groups
  1. description
    Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (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
    FG000
    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
    FG001
    title
    Arm B: Placebo Plus Fulvestrant
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        116
      2. group Id
        FG001
        num Subjects
        128
      type
      On study treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        21
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        182
      2. group Id
        FG001
        num Subjects
        186
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        181
      2. group Id
        FG001
        num Subjects
        185
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        37
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        149
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers included participants who had an event (progressive disease or death) and participants who were off the treatment and were alive at study conclusion.
Complete source fields
groups
  1. description
    Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (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
    FG000
    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
    FG001
    title
    Arm B: Placebo Plus Fulvestrant
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        116
      2. group Id
        FG001
        num Subjects
        128
      type
      On study treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        21
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        182
      2. group Id
        FG001
        num Subjects
        186
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        181
      2. group Id
        FG001
        num Subjects
        185
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        37
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        149
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Completers included participants who had an event (progressive disease or death) and participants who were off the treatment and were alive at study conclusion.

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

Preserved source evidence · Not medical advice