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NCT03155997 · OUTCOME

Invasive Disease Free Survival (IDFS)

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer · Source last updated 2026-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

What was measured

IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.

Analysis population: All randomized participants (including the censored participants). 2672 participants were censored in "150 mg Abemaciclib + Endocrine Therapy," 2642 participants were censored in "Endocrine Therapy."

Groups in this outcome

150 mg Abemaciclib + Endocrine Therapy

Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Endocrine Therapy

Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
150 mg Abemaciclib + Endocrine Therapy2808
Endocrine Therapy2829

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
150 mg Abemaciclib + Endocrine TherapyNANot reportedNANAThere were not enough events to compute a median or 95% confidence interval.
Endocrine TherapyNANot reportedNANAThere were not enough events to compute a median or 95% confidence interval.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.598
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.932
    estimate Comment
    Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00957
    param Type
    Hazard Ratio (HR)
    param Value
    0.747
    statistical Comment
    Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.598
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.932
    estimate Comment
    Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00957
    param Type
    Hazard Ratio (HR)
    param Value
    0.747
    statistical Comment
    Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        There were not enough events to compute a median or 95% confidence interval.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        There were not enough events to compute a median or 95% confidence interval.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2808
    2. group Id
      OG001
      value
      2829
    units
    Participants
description
IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
    id
    OG000
    title
    150 mg Abemaciclib + Endocrine Therapy
  2. description
    Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
    id
    OG001
    title
    Endocrine Therapy
param Type
MEDIAN
population Description
All randomized participants (including the censored participants). 2672 participants were censored in "150 mg Abemaciclib + Endocrine Therapy," 2642 participants were censored in "Endocrine Therapy."
reporting Status
POSTED
time Frame
Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
title
Invasive Disease Free Survival (IDFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice