NCT00045032 · OUTCOME

RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-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: 95% Confidence Interval
Time frame: Years 3, 5, 7, 8

What was measured

RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants free of RDFS events (i.e., the RDFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.

Analysis population: FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.

Groups in this outcome

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
Herceptin 1-Year Arm	1552
Herceptin 2-Year Arm	1553

Reported measurements

Year 3

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Herceptin 1-Year Arm	87.3	Not reported	85.6	89.0	Not reported
Herceptin 2-Year Arm	89.9	Not reported	88.4	91.4	Not reported

Year 5

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Herceptin 1-Year Arm	81.9	Not reported	79.9	83.8	Not reported
Herceptin 2-Year Arm	83.0	Not reported	81.1	84.9	Not reported

Year 7

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Herceptin 1-Year Arm	78.5	Not reported	76.4	80.6	Not reported
Herceptin 2-Year Arm	78.9	Not reported	76.9	81.0	Not reported

Year 8

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Herceptin 1-Year Arm	77.2	Not reported	75.1	79.3	Not reported
Herceptin 2-Year Arm	77.7	Not reported	75.5	79.8	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
85.6
upper Limit
89.0
value
87.3
group Id
OG001
lower Limit
88.4
upper Limit
91.4
value
89.9
title
Year 3
categories
measurements
group Id
OG000
lower Limit
79.9
upper Limit
83.8
value
81.9
group Id
OG001
lower Limit
81.1
upper Limit
84.9
value
83.0
title
Year 5
categories
measurements
group Id
OG000
lower Limit
76.4
upper Limit
80.6
value
78.5
group Id
OG001
lower Limit
76.9
upper Limit
81.0
value
78.9
title
Year 7
categories
measurements
group Id
OG000
lower Limit
75.1
upper Limit
79.3
value
77.2
group Id
OG001
lower Limit
75.5
upper Limit
79.8
value
77.7
title
Year 8

denoms

counts
group Id
OG000
value
1552
group Id
OG001
value
1553
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
OG000
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
OG001
title
Herceptin 2-Year Arm

param Type

NUMBER

population Description

FAS Population 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.

reporting Status

POSTED

time Frame

Years 3, 5, 7, 8

title

RDFS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice