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NCT02000622 · OUTCOME

Overall Survival (OS) at Extended OS

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. · Source last updated 2026-02-13

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
Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.

What was measured

Time from randomisation until death due to any cause.

Analysis population: Full Analysis Set (FAS) consisting of all randomised patients

Groups in this outcome

Olaparib 300 mg bd

Olaparib 300 mg bd tablets

Chemotherapy

Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin

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

Analysis denominator · Participants

GroupSource count
Olaparib 300 mg bd205
Chemotherapy97

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300 mg bd19.3Not reported17.221.6Not reported
Chemotherapy17.1Not reported13.921.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    estimate Comment
    Hazard ratio \<1 favours olaparib.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4167
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Comment
    Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    estimate Comment
    Hazard ratio \<1 favours olaparib.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4167
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Comment
    Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.2
        upper Limit
        21.6
        value
        19.3
      2. group Id
        OG001
        lower Limit
        13.9
        upper Limit
        21.9
        value
        17.1
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      97
    units
    Participants
description
Time from randomisation until death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Olaparib 300 mg bd tablets
    id
    OG000
    title
    Olaparib 300 mg bd
  2. description
    Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
Full Analysis Set (FAS) consisting of all randomised patients
reporting Status
POSTED
time Frame
Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.
title
Overall Survival (OS) at Extended OS
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice