NCT02492711 · OUTCOME

Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer · Source last updated 2025-03-17

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: Throughout the study, average 21 months

What was measured

Overall survival is the time from randomization until death from any cause

Analysis population: The OS outcome measure is calculated only for the randomized study efficacy population. The 88 participants in the sub-study were not part of the efficacy population

Groups in this outcome

Margetuximab Plus Chemotherapy

Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.

Trastuzumab Plus Chemotherapy

Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.

Margetuximab Infusion Substudy

Margetuximab with or without chemotherapy

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
Margetuximab Plus Chemotherapy	266
Trastuzumab Plus Chemotherapy	270
Margetuximab Infusion Substudy	0

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Margetuximab Plus Chemotherapy	21.6	Not reported	0.66	61.44	Not reported
Trastuzumab Plus Chemotherapy	21.9	Not reported	0.07	64.53	Not reported

Source statistical analyses

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

ci Lower Limit
0.774
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.165
estimate Comment
Stratified Cox Proportional Model
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.6204
param Type
Hazard Ratio (HR)
param Value
0.950
statistical Comment
Stratified Log-Rank Test
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.774
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.165
estimate Comment
Stratified Cox Proportional Model
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.6204
param Type
Hazard Ratio (HR)
param Value
0.950
statistical Comment
Stratified Log-Rank Test
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
0.66
upper Limit
61.44
value
21.6
group Id
OG001
lower Limit
0.07
upper Limit
64.53
value
21.9

denoms

counts
group Id
OG000
value
266
group Id
OG001
value
270
group Id
OG002
value
0
units
Participants

description

Overall survival is the time from randomization until death from any cause

dispersion Type

95% Confidence Interval

groups

description
Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
id
OG000
title
Margetuximab Plus Chemotherapy
description
Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
id
OG001
title
Trastuzumab Plus Chemotherapy
description
Margetuximab with or without chemotherapy
id
OG002
title
Margetuximab Infusion Substudy

param Type

MEDIAN

population Description

The OS outcome measure is calculated only for the randomized study efficacy population. The 88 participants in the sub-study were not part of the efficacy population

reporting Status

POSTED

time Frame

Throughout the study, average 21 months

title

Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice