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NCT02107703 · FLOW

Participant flow

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer · Source last updated 2025-10-21

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 every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg 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 were met.
    id
    FG000
    title
    Abemaciclib + Fulvestrant
  2. description
    Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
    id
    FG001
    title
    Placebo + Fulvestrant
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        21
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        9
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        5
      type
      On study treatment/follow up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        446
      2. group Id
        FG001
        num Subjects
        223
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        441
      2. group Id
        FG001
        num Subjects
        223
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        332
      2. group Id
        FG001
        num Subjects
        188
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        114
      2. group Id
        FG001
        num Subjects
        35
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
With Overall Survival (OS) as a key outcome, participants who completed included those who died due to any cause and those who were off treatment, alive and in follow-up at the time of the final OS analysis.
Complete source fields
groups
  1. description
    Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg 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 were met.
    id
    FG000
    title
    Abemaciclib + Fulvestrant
  2. description
    Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
    id
    FG001
    title
    Placebo + Fulvestrant
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        21
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        9
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        5
      type
      On study treatment/follow up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        446
      2. group Id
        FG001
        num Subjects
        223
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        441
      2. group Id
        FG001
        num Subjects
        223
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        332
      2. group Id
        FG001
        num Subjects
        188
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        114
      2. group Id
        FG001
        num Subjects
        35
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
With Overall Survival (OS) as a key outcome, participants who completed included those who died due to any cause and those who were off treatment, alive and in follow-up at the time of the final OS analysis.

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

Preserved source evidence · Not medical advice