Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02425891 · OUTCOME

Percentage of Participants With an Objective Response of CR or PR According 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
Percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to approximately 34 months

What was measured

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

Analysis population: The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline.

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-Paclitaxel183
Atezolizumab Plus Nab-Paclitaxel185

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-Paclitaxel42.6Not reportedNot reportedNot reportedNot reported
Atezolizumab Plus Nab-Paclitaxel58.9Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    5.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    26.92
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0016
    param Type
    Difference in Overall Response Rates
    param Value
    16.30
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    5.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    26.92
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0016
    param Type
    Difference in Overall Response Rates
    param Value
    16.30
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42.6
      2. group Id
        OG001
        value
        58.9
denoms
  1. counts
    1. group Id
      OG000
      value
      183
    2. group Id
      OG001
      value
      185
    units
    Participants
description
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
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 PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline.
reporting Status
POSTED
time Frame
Baseline up to approximately 34 months
title
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice