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NCT03125902 · OUTCOME

Overall Survival (OS) in the ITT Population

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

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
From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)

What was measured

OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.

Analysis population: ITT population: all randomized participants, whether or not the assigned study treatment was received

Groups in this outcome

Placebo and Paclitaxel

Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Atezolizumab and Paclitaxel

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle 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 and Paclitaxel220
Atezolizumab and Paclitaxel431

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel22.80Not reported17.0828.29Not reported
Atezolizumab and Paclitaxel19.19Not reported16.5922.05Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.43
    group Description
    Stratified analysis
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3425
    param Type
    Hazard Ratio (HR)
    param Value
    1.12
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.48
    group Description
    Unstratified Analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2166
    param Type
    Hazard Ratio (HR)
    param Value
    1.16
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.43
    group Description
    Stratified analysis
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3425
    param Type
    Hazard Ratio (HR)
    param Value
    1.12
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.92
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.48
    group Description
    Unstratified Analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2166
    param Type
    Hazard Ratio (HR)
    param Value
    1.16
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.08
        upper Limit
        28.29
        value
        22.80
      2. group Id
        OG001
        lower Limit
        16.59
        upper Limit
        22.05
        value
        19.19
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    2. group Id
      OG001
      value
      431
    units
    Participants
description
OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab and Paclitaxel
param Type
MEDIAN
population Description
ITT population: all randomized participants, whether or not the assigned study treatment was received
reporting Status
POSTED
time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
title
Overall Survival (OS) in the ITT Population
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice