Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01740427 · OUTCOME

Overall Survival (OS): Final Analysis

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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 death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)

What was measured

OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at final analysis.

Analysis population: ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.

Groups in this outcome

Palbociclib Plus Letrozole

Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

Placebo Plus Letrozole

Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

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

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole444
Placebo Plus Letrozole222

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole53.8Not reported49.859.2Not reported
Placebo Plus Letrozole49.8Not reported42.356.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.755
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.124
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.208706
    p Value Comment
    1-sided p-value from the stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.921
    statistical Method
    Stratified Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.755
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.124
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.208706
    p Value Comment
    1-sided p-value from the stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.921
    statistical Method
    Stratified Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.8
        upper Limit
        59.2
        value
        53.8
      2. group Id
        OG001
        lower Limit
        42.3
        upper Limit
        56.4
        value
        49.8
denoms
  1. counts
    1. group Id
      OG000
      value
      444
    2. group Id
      OG001
      value
      222
    units
    Participants
description
OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at final analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG000
    title
    Palbociclib Plus Letrozole
  2. description
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG001
    title
    Placebo Plus Letrozole
param Type
MEDIAN
population Description
ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
reporting Status
POSTED
time Frame
From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)
title
Overall Survival (OS): Final Analysis
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice