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NCT01958021 · OUTCOME

Progression Free Survival (PFS) by Investigator Assessment

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer · Source last updated 2025-03-07

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
Up to 23 months

What was measured

PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression.PFS was assessed by investigator assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval

Analysis population: Full Analysis Set (FAS) including all randomized participants

Groups in this outcome

Ribociclib + Letrozole

Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral

Placebo + Letrozole

Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole

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

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole334
Placebo + Letrozole334

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ribociclib + LetrozoleNANot reported19.3NANA = not estimable due to the insufficient number of participants with events
Placebo + Letrozole14.7Not reported13.016.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.429
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.720
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00000329
    param Type
    Hazard Ratio (HR)
    param Value
    0.556
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.429
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.720
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.00000329
    param Type
    Hazard Ratio (HR)
    param Value
    0.556
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = not estimable due to the insufficient number of participants with events
        group Id
        OG000
        lower Limit
        19.3
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        13.0
        upper Limit
        16.5
        value
        14.7
denoms
  1. counts
    1. group Id
      OG000
      value
      334
    2. group Id
      OG001
      value
      334
    units
    Participants
description
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression.PFS was assessed by investigator assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval
dispersion Type
95% Confidence Interval
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
    id
    OG000
    title
    Ribociclib + Letrozole
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
    id
    OG001
    title
    Placebo + Letrozole
param Type
MEDIAN
population Description
Full Analysis Set (FAS) including all randomized participants
reporting Status
POSTED
time Frame
Up to 23 months
title
Progression Free Survival (PFS) by Investigator Assessment
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice