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NCT02513394 · OUTCOME

Overall Survival (OS)

PALbociclib CoLlaborative Adjuvant Study · Source last updated 2026-06-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
4 years

What was measured

Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.

Groups in this outcome

Palbociclib Plus Endocrine Therapy (Arm A)

Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

Endocrine Therapy Alone (Arm B)

Standard adjuvant endocrine therapy for a duration of at least 5 years.

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 Endocrine Therapy (Arm A)2884
Endocrine Therapy Alone (Arm B)2877

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Endocrine Therapy (Arm A)93.8Not reportedNot reportedNot reportedNot reported
Endocrine Therapy Alone (Arm B)95.2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.78
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.32
Complete source fields
analyses
  1. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.78
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.32
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        93.8
      2. group Id
        OG001
        value
        95.2
denoms
  1. counts
    1. group Id
      OG000
      value
      2884
    2. group Id
      OG001
      value
      2877
    units
    Participants
description
Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.
groups
  1. description
    Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
    id
    OG000
    title
    Palbociclib Plus Endocrine Therapy (Arm A)
  2. description
    Standard adjuvant endocrine therapy for a duration of at least 5 years.
    id
    OG001
    title
    Endocrine Therapy Alone (Arm B)
param Type
NUMBER
reporting Status
POSTED
time Frame
4 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice