NCT00045032 · OUTCOME

Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up

Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer · Source last updated 2017-04-27

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: From Baseline until time of event (median of 11 years)

What was measured

OS events referred to death from any cause. The percentage of participants who died was reported.

Analysis population: FAS Population

Groups in this outcome

Observation Arm

Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.

Herceptin 1-Year Arm

Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.

Herceptin 2-Year Arm

Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.

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
Observation Arm	1697
Herceptin 1-Year Arm	1702
Herceptin 2-Year Arm	1700

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Observation Arm	23.9	Not reported	Not reported	Not reported	Not reported
Herceptin 1-Year Arm	18.8	Not reported	Not reported	Not reported	Not reported
Herceptin 2-Year Arm	18.4	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
0.64
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
estimate Comment
HR for Herceptin 1-Year Arm versus Observation Arm.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.74
ci Lower Limit
0.62
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.83
estimate Comment
HR for Herceptin 2-Year Arm versus Observation Arm.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.72

Complete source fields

analyses

ci Lower Limit
0.64
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
estimate Comment
HR for Herceptin 1-Year Arm versus Observation Arm.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.74
ci Lower Limit
0.62
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.83
estimate Comment
HR for Herceptin 2-Year Arm versus Observation Arm.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.72

classes

categories
measurements
group Id
OG000
value
23.9
group Id
OG001
value
18.8
group Id
OG002
value
18.4

denoms

counts
group Id
OG000
value
1697
group Id
OG001
value
1702
group Id
OG002
value
1700
units
Participants

description

OS events referred to death from any cause. The percentage of participants who died was reported.

groups

description
Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
id
OG000
title
Observation Arm
description
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
id
OG001
title
Herceptin 1-Year Arm
description
Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
id
OG002
title
Herceptin 2-Year Arm

param Type

NUMBER

population Description

FAS Population

reporting Status

POSTED

time Frame

From Baseline until time of event (median of 11 years)

title

Percentage of Participants With OS Events Compared to Observation: 11-Year Median Follow-Up

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice