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NCT02032823 · OUTCOME

Invasive Disease Free Survival (IDFS)

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer · Source last updated 2026-07-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

What was measured

An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.

Analysis population: Full Analysis Set (FAS)

Groups in this outcome

Olaparib

Olaparib tablets 300mg taken orally twice daily.

Placebo

Placebo tablets taken orally twice daily.

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

Analysis denominator · Participants

GroupSource count
Olaparib921
Placebo915

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib106Not reportedNot reportedNot reportedNot reported
Placebo178Not 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
    0.409
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.5
    ci Upper Limit
    0.816
    estimate Comment
    Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0000073
    p Value Comment
    A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
    param Type
    Hazard Ratio (HR)
    param Value
    0.581
    statistical Comment
    Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.409
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.5
    ci Upper Limit
    0.816
    estimate Comment
    Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0000073
    p Value Comment
    A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.
    param Type
    Hazard Ratio (HR)
    param Value
    0.581
    statistical Comment
    Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        178
denoms
  1. counts
    1. group Id
      OG000
      value
      921
    2. group Id
      OG001
      value
      915
    units
    Participants
description
An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.
groups
  1. description
    Olaparib tablets 300mg taken orally twice daily.
    id
    OG000
    title
    Olaparib
  2. description
    Placebo tablets taken orally twice daily.
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS)
reporting Status
POSTED
time Frame
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
title
Invasive Disease Free Survival (IDFS)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice