NCT02425891 · OUTCOME

Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 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: 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 ORR-evaluable population is defined as patients in the ITT population 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

Group	Source count
Placebo Plus Nab-Paclitaxel	449
Atezolizumab Plus Nab-Paclitaxel	450

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo Plus Nab-Paclitaxel	45.9	Not reported	Not reported	Not reported	Not reported
Atezolizumab Plus Nab-Paclitaxel	56.0	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
3.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.84
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0021
param Type
Difference in Overall Response Rates
param Value
10.12
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
3.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.84
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0021
param Type
Difference in Overall Response Rates
param Value
10.12
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
value
45.9
group Id
OG001
value
56.0

denoms

counts
group Id
OG000
value
449
group Id
OG001
value
450
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

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

NUMBER

population Description

The ORR-evaluable population is defined as patients in the ITT population 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 Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants

type

SECONDARY

unit Of Measure

Percentage of Participants

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Preserved source evidence · Not medical advice