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NCT02422615 · OUTCOME

Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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 randomization to first documented progression or death, assessed up to approximately 26 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 via BIRC 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.

Analysis population: FAS including all randomized participants

Groups in this outcome

Ribociclib + Fulvestrant

Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

Placebo + Fulvestrant

Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

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 + Fulvestrant484
Placebo + Fulvestrant242

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ribociclib + FulvestrantNANot reported18.2NANA: Not estimable due to the insufficient number of participants with events
Placebo + Fulvestrant10.9Not reported3.817.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.345
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.703
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    0.492
Complete source fields
analyses
  1. ci Lower Limit
    0.345
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.703
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    0.492
classes
  1. categories
    1. measurements
      1. comment
        NA: Not estimable due to the insufficient number of participants with events
        group Id
        OG000
        lower Limit
        18.2
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        3.8
        upper Limit
        17.2
        value
        10.9
denoms
  1. counts
    1. group Id
      OG000
      value
      484
    2. group Id
      OG001
      value
      242
    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 via BIRC 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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    OG000
    title
    Ribociclib + Fulvestrant
  2. description
    Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    OG001
    title
    Placebo + Fulvestrant
param Type
MEDIAN
population Description
FAS including all randomized participants
reporting Status
POSTED
time Frame
From randomization to first documented progression or death, assessed up to approximately 26 months
title
Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice