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NCT00045032 · OUTCOME

OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 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
95% Confidence Interval
Time frame
Years 3, 5, 7, 9, 10, 11, 12

What was measured

OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.

Analysis population: FAS Population 1Y2Y

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

GroupSource count
Herceptin 1-Year Arm1552
Herceptin 2-Year Arm1553

Reported measurements

Year 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm96.5Not reported95.697.4Not reported
Herceptin 2-Year Arm97.4Not reported96.698.2Not reported
Year 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm91.4Not reported90.092.8Not reported
Herceptin 2-Year Arm92.6Not reported91.293.9Not reported
Year 7
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm88.6Not reported87.090.2Not reported
Herceptin 2-Year Arm88.7Not reported87.190.3Not reported
Year 9
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm86.7Not reported85.088.5Not reported
Herceptin 2-Year Arm85.9Not reported84.287.7Not reported
Year 10
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm85.4Not reported83.687.2Not reported
Herceptin 2-Year Arm85.1Not reported83.386.9Not reported
Year 11
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm84.7Not reported82.986.6Not reported
Herceptin 2-Year Arm84.4Not reported82.586.2Not reported
Year 12
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Herceptin 1-Year Arm84.1Not reported82.186.1Not reported
Herceptin 2-Year Arm83.6Not reported81.585.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        95.6
        upper Limit
        97.4
        value
        96.5
      2. group Id
        OG001
        lower Limit
        96.6
        upper Limit
        98.2
        value
        97.4
    title
    Year 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.0
        upper Limit
        92.8
        value
        91.4
      2. group Id
        OG001
        lower Limit
        91.2
        upper Limit
        93.9
        value
        92.6
    title
    Year 5
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.0
        upper Limit
        90.2
        value
        88.6
      2. group Id
        OG001
        lower Limit
        87.1
        upper Limit
        90.3
        value
        88.7
    title
    Year 7
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        85.0
        upper Limit
        88.5
        value
        86.7
      2. group Id
        OG001
        lower Limit
        84.2
        upper Limit
        87.7
        value
        85.9
    title
    Year 9
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        83.6
        upper Limit
        87.2
        value
        85.4
      2. group Id
        OG001
        lower Limit
        83.3
        upper Limit
        86.9
        value
        85.1
    title
    Year 10
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.9
        upper Limit
        86.6
        value
        84.7
      2. group Id
        OG001
        lower Limit
        82.5
        upper Limit
        86.2
        value
        84.4
    title
    Year 11
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.1
        upper Limit
        86.1
        value
        84.1
      2. group Id
        OG001
        lower Limit
        81.5
        upper Limit
        85.6
        value
        83.6
    title
    Year 12
denoms
  1. counts
    1. group Id
      OG000
      value
      1552
    2. group Id
      OG001
      value
      1553
    units
    Participants
description
OS events referred to death from any cause. The percentage of participants alive (i.e., the OS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the final analysis with an 11-year median follow-up for OS events.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
reporting Status
POSTED
time Frame
Years 3, 5, 7, 9, 10, 11, 12
title
OS Rate According to Kaplan-Meier Analysis in 1-Year Versus 2-Year Herceptin: 11-Year Median Follow-Up
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice