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NCT02425891 · OUTCOME

DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) · Source last updated 2022-07-19

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

Measure
NUMBER
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to approximately 34 months

What was measured

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.

Analysis population: The duration of response (DOR)-evaluable population is defined as patients with an objective response.

Groups in this outcome

Placebo Plus Nab-Paclitaxel

Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Atezolizumab Plus Nab-Paclitaxel

Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Placebo Plus Nab-Paclitaxel78
Atezolizumab Plus Nab-Paclitaxel109

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-Paclitaxel5.49Not reported3.717.13Not reported
Atezolizumab Plus Nab-Paclitaxel8.48Not reported7.339.66Not 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
    0.86
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0047
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    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
    0.86
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Unstratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0047
    param Type
    Hazard Ratio (HR)
    param Value
    0.60
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.71
        upper Limit
        7.13
        value
        5.49
      2. group Id
        OG001
        lower Limit
        7.33
        upper Limit
        9.66
        value
        8.48
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    2. group Id
      OG001
      value
      109
    units
    Participants
description
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo Plus Nab-Paclitaxel
  2. description
    Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab Plus Nab-Paclitaxel
param Type
NUMBER
population Description
The duration of response (DOR)-evaluable population is defined as patients with an objective response.
reporting Status
POSTED
time Frame
Baseline up to approximately 34 months
title
DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice