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NCT02425891 · OUTCOME

Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to approximately 58 months

What was measured

Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.

Analysis population: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.

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-Paclitaxel400
Atezolizumab Plus Nab-Paclitaxel406

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-Paclitaxel7.98Not reported5.6511.10Not reported
Atezolizumab Plus Nab-Paclitaxel8.18Not reported6.0110.94Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8078
    param Type
    Hazard Ratio (HR)
    param Value
    0.98
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8078
    param Type
    Hazard Ratio (HR)
    param Value
    0.98
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.65
        upper Limit
        11.10
        value
        7.98
      2. group Id
        OG001
        lower Limit
        6.01
        upper Limit
        10.94
        value
        8.18
denoms
  1. counts
    1. group Id
      OG000
      value
      400
    2. group Id
      OG001
      value
      406
    units
    Participants
description
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
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
MEDIAN
population Description
The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.
reporting Status
POSTED
time Frame
Baseline up to approximately 58 months
title
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice