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NCT02000622 · OUTCOME

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

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
Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.

What was measured

Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. 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.

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 bd7.0Not reported5.78.3Not reported
Chemotherapy4.2Not reported2.84.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.80
    estimate Comment
    Hazard ratio \<1 favours olaparib.
    group Description
    Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0009
    p Value Comment
    A priori threshold for statistical significance (2-sided) is 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    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
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.80
    estimate Comment
    Hazard ratio \<1 favours olaparib.
    group Description
    Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0009
    p Value Comment
    A priori threshold for statistical significance (2-sided) is 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    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
        5.7
        upper Limit
        8.3
        value
        7.0
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        4.3
        value
        4.2
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 objective radiological progression or death by any cause in the absence of objective progression. 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.
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
Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.
title
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice