NCT01419197 · OUTCOME

Overall Survival

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy · Source last updated 2016-10-12

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 to the clinical cut-off date of 11 Feb 2013 (up to 2 years)

What was measured

Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.

Analysis population: Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Trastuzumab Emtansine

Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

Treatment of Physician's Choice

Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.

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
Trastuzumab Emtansine	404
Treatment of Physician's Choice	198

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab Emtansine	NA	Not reported	13.14	NA	The median and the upper limit of the confidence interval could not be estimated due to too few events.
Treatment of Physician's Choice	14.9	Not reported	11.27	NA	The upper limit of the confidence interval could not be estimated due to too few events.

Source statistical analyses

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

ci Lower Limit
0.369
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.826
estimate Comment
The hazard ratio was estimated by Cox regression.
group Description
The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0034
p Value Comment
The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).
param Type
Hazard Ratio (HR)
param Value
0.552
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.369
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.826
estimate Comment
The hazard ratio was estimated by Cox regression.
group Description
The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0034
p Value Comment
The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).
param Type
Hazard Ratio (HR)
param Value
0.552
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
comment
The median and the upper limit of the confidence interval could not be estimated due to too few events.
group Id
OG000
lower Limit
13.14
upper Limit
NA
value
NA
comment
The upper limit of the confidence interval could not be estimated due to too few events.
group Id
OG001
lower Limit
11.27
upper Limit
NA
value
14.9

denoms

counts
group Id
OG000
value
404
group Id
OG001
value
198
units
Participants

description

Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.

dispersion Type

95% Confidence Interval

groups

description
Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
id
OG000
title
Trastuzumab Emtansine
description
Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
id
OG001
title
Treatment of Physician's Choice

param Type

MEDIAN

population Description

Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.

reporting Status

POSTED

time Frame

Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)

title

Overall Survival

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice