Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02513394 · OUTCOME

Invasive Disease Free Survival (iDFS)

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 participants
Interval / dispersion
Not reported
Time frame
4 years

What was measured

Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palbociclib Plus Endocrine Therapy (Arm A)84.2Not reportedNot reportedNot reportedNot reported
Endocrine Therapy Alone (Arm B)84.5Not 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
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    estimate Comment
    This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.65
    param Type
    Hazard Ratio (HR)
    param Value
    0.96
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    estimate Comment
    This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.65
    param Type
    Hazard Ratio (HR)
    param Value
    0.96
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        84.2
      2. group Id
        OG001
        value
        84.5
denoms
  1. counts
    1. group Id
      OG000
      value
      2884
    2. group Id
      OG001
      value
      2877
    units
    Participants
description
Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.
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
Invasive Disease Free Survival (iDFS)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice