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NCT02246621 · OUTCOME

Progression Free Survival (PFS)

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer · Source last updated 2026-02-03

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
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

What was measured

PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by 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 who had evaluable data. Censored participants: Abemaciclib + NSAI = 190 and Placebo + NSAI =57.

Groups in this outcome

Abemaciclib + NSAI

150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).

Placebo + NSAI

Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).

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 + NSAI328
Placebo + NSAI165

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abemaciclib + NSAI28.18Not reported23.51NAThe upper limit of the 95% CI was not evaluable due to the high censoring rate.
Placebo + NSAI14.76Not reported11.2419.20Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.418
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.698
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.000002
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.418
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.698
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.000002
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% CI was not evaluable due to the high censoring rate.
        group Id
        OG000
        lower Limit
        23.51
        upper Limit
        NA
        value
        28.18
      2. group Id
        OG001
        lower Limit
        11.24
        upper Limit
        19.20
        value
        14.76
denoms
  1. counts
    1. group Id
      OG000
      value
      328
    2. group Id
      OG001
      value
      165
    units
    Participants
description
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by 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
    150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
    id
    OG000
    title
    Abemaciclib + NSAI
  2. description
    Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
    id
    OG001
    title
    Placebo + NSAI
param Type
MEDIAN
population Description
All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 190 and Placebo + NSAI =57.
reporting Status
POSTED
time Frame
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice