NCT01419197 · OUTCOME

6-month and 1-year Survival (Final Analysis)

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)

What was measured

6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.

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

6-Month Survival

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab Emtansine	91.3	Not reported	88.52	94.11	Not reported
Treatment of Physician's Choice	78.9	Not reported	72.78	85.04	Not reported

1-Year Survival

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab Emtansine	76.5	Not reported	72.23	80.79	Not reported
Treatment of Physician's Choice	65.6	Not reported	58.36	72.76	Not reported

Source statistical analyses

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

ci Lower Limit
5.67
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.14
group Description
6-month survival
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0003
p Value Comment
The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.
param Type
Difference in Survival Percentage
param Value
12.4
statistical Method
z-test
tested Non Inferiority
false
ci Lower Limit
2.58
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.33
group Description
1-year survival
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0104
p Value Comment
The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.
param Type
Difference in Survival Percentage
param Value
11.0
statistical Method
z-test
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
5.67
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.14
group Description
6-month survival
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0003
p Value Comment
The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.
param Type
Difference in Survival Percentage
param Value
12.4
statistical Method
z-test
tested Non Inferiority
false
ci Lower Limit
2.58
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.33
group Description
1-year survival
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0104
p Value Comment
The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.
param Type
Difference in Survival Percentage
param Value
11.0
statistical Method
z-test
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
88.52
upper Limit
94.11
value
91.3
group Id
OG001
lower Limit
72.78
upper Limit
85.04
value
78.9
title
6-Month Survival
categories
measurements
group Id
OG000
lower Limit
72.23
upper Limit
80.79
value
76.5
group Id
OG001
lower Limit
58.36
upper Limit
72.76
value
65.6
title
1-Year Survival

denoms

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

description

6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.

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

NUMBER

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 13 Feb 2015 (up to 4 years)

title

6-month and 1-year Survival (Final Analysis)

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice