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NCT01740427 · OUTCOME

Survival Probability at 1 Year, 2 Year and 3 Year

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
NUMBER
Unit
Percent probability
Interval / dispersion
95% Confidence Interval
Time frame
1, 2 and 3 years after randomization

What was measured

One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.

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

1 year survival probability
Values in Percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole92.7Not reported89.894.7Not reported
Placebo Plus Letrozole94.9Not reported91.097.2Not reported
2 year survival probability
Values in Percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole78.4Not reported74.182.0Not reported
Placebo Plus Letrozole82.5Not reported76.687.0Not reported
3 year survival probability
Values in Percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole69.8Not reported65.173.9Not reported
Placebo Plus Letrozole65.0Not reported58.071.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.8
        upper Limit
        94.7
        value
        92.7
      2. group Id
        OG001
        lower Limit
        91.0
        upper Limit
        97.2
        value
        94.9
    title
    1 year survival probability
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.1
        upper Limit
        82.0
        value
        78.4
      2. group Id
        OG001
        lower Limit
        76.6
        upper Limit
        87.0
        value
        82.5
    title
    2 year survival probability
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.1
        upper Limit
        73.9
        value
        69.8
      2. group Id
        OG001
        lower Limit
        58.0
        upper Limit
        71.1
        value
        65.0
    title
    3 year survival probability
denoms
  1. counts
    1. group Id
      OG000
      value
      444
    2. group Id
      OG001
      value
      222
    units
    Participants
description
One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.
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
NUMBER
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
1, 2 and 3 years after randomization
title
Survival Probability at 1 Year, 2 Year and 3 Year
type
SECONDARY
unit Of Measure
Percent probability

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

Preserved source evidence · Not medical advice