NCT02425891 · OUTCOME

OS 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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline until death due to any cause (up to approximately 58 months)

What was measured

OS was defined as the time from the date of randomization to the date of death from any cause.

Analysis population: The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

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

Group	Source count
Placebo Plus Nab-Paclitaxel	184
Atezolizumab Plus Nab-Paclitaxel	185

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo Plus Nab-Paclitaxel	17.91	Not reported	13.63	20.30	Not reported
Atezolizumab Plus Nab-Paclitaxel	25.43	Not reported	19.55	30.69	Not reported

Source statistical analyses

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

ci Lower Limit
0.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0016
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0016
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
13.63
upper Limit
20.30
value
17.91
group Id
OG001
lower Limit
19.55
upper Limit
30.69
value
25.43

denoms

counts
group Id
OG000
value
184
group Id
OG001
value
185
units
Participants

description

OS was defined as the time from the date of randomization to the date of death from any cause.

dispersion Type

95% Confidence Interval

groups

description
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
id
OG000
title
Placebo Plus Nab-Paclitaxel
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 PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

reporting Status

POSTED

time Frame

Baseline until death due to any cause (up to approximately 58 months)

title

OS in Participants With Detectable PD-L1

type

PRIMARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice