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NCT02000622 · OUTCOME

Time to Second Progression or Death (PFS2)

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
Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.

What was measured

Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.

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 bd13.2Not reported10.915.3Not reported
Chemotherapy9.3Not reported7.310.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    Hazard ratio \<1 favours olaparib.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0033
    p Value Comment
    PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.
    param Type
    Hazard Ratio (HR)
    param Value
    0.57
    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
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.83
    estimate Comment
    Hazard ratio \<1 favours olaparib.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0033
    p Value Comment
    PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.
    param Type
    Hazard Ratio (HR)
    param Value
    0.57
    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
        10.9
        upper Limit
        15.3
        value
        13.2
      2. group Id
        OG001
        lower Limit
        7.3
        upper Limit
        10.4
        value
        9.3
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      97
    units
    Participants
description
Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.
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
Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.
title
Time to Second Progression or Death (PFS2)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice