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NCT02107703 · OUTCOME

Progression-Free Survival (PFS)

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)

What was measured

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

Analysis population: All randomized participants. Censored participants: Abemaciclib=224.

Groups in this outcome

Abemaciclib + Fulvestrant

Abemaciclib 150 mg 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.

Placebo + Fulvestrant

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.

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

Analysis denominator · Participants

GroupSource count
Abemaciclib + Fulvestrant446
Placebo + Fulvestrant223

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abemaciclib + Fulvestrant16.4Not reported14.419.3Not reported
Placebo + Fulvestrant9.3Not reported7.411.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.449
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.681
    group Description
    The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0000001
    p Value Comment
    This is two sided P value and it is statistically significant.
    param Type
    Hazard Ratio (HR)
    param Value
    0.553
    statistical Comment
    Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.449
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.681
    group Description
    The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0000001
    p Value Comment
    This is two sided P value and it is statistically significant.
    param Type
    Hazard Ratio (HR)
    param Value
    0.553
    statistical Comment
    Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.4
        upper Limit
        19.3
        value
        16.4
      2. group Id
        OG001
        lower Limit
        7.4
        upper Limit
        11.4
        value
        9.3
denoms
  1. counts
    1. group Id
      OG000
      value
      446
    2. group Id
      OG001
      value
      223
    units
    Participants
description
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Abemaciclib 150 mg 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
    OG000
    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
    OG001
    title
    Placebo + Fulvestrant
param Type
MEDIAN
population Description
All randomized participants. Censored participants: Abemaciclib=224.
reporting Status
POSTED
time Frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
title
Progression-Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice