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NCT00045032 · OUTCOME

RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 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

RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS 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

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

GroupSource count
Observation Arm1697
Herceptin 1-Year Arm1702
Herceptin 2-Year Arm1700

Reported measurements

Year 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Observation Arm76.4Not reported74.378.4Not reported
Herceptin 1-Year Arm82.7Not reported80.984.6Not reported
Herceptin 2-Year Arm86.0Not reported84.387.6Not reported
Year 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Observation Arm71.9Not reported69.774.1Not reported
Herceptin 1-Year Arm78.4Not reported76.480.4Not reported
Herceptin 2-Year Arm79.9Not reported77.981.9Not reported
Year 7
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Observation Arm69.0Not reported66.771.3Not reported
Herceptin 1-Year Arm75.7Not reported73.677.8Not reported
Herceptin 2-Year Arm76.7Not reported74.678.8Not reported
Year 8
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Observation Arm68.4Not reported66.170.7Not reported
Herceptin 1-Year Arm75.1Not reported72.977.2Not reported
Herceptin 2-Year Arm75.8Not reported73.677.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.3
        upper Limit
        78.4
        value
        76.4
      2. group Id
        OG001
        lower Limit
        80.9
        upper Limit
        84.6
        value
        82.7
      3. group Id
        OG002
        lower Limit
        84.3
        upper Limit
        87.6
        value
        86.0
    title
    Year 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.7
        upper Limit
        74.1
        value
        71.9
      2. group Id
        OG001
        lower Limit
        76.4
        upper Limit
        80.4
        value
        78.4
      3. group Id
        OG002
        lower Limit
        77.9
        upper Limit
        81.9
        value
        79.9
    title
    Year 5
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.7
        upper Limit
        71.3
        value
        69.0
      2. group Id
        OG001
        lower Limit
        73.6
        upper Limit
        77.8
        value
        75.7
      3. group Id
        OG002
        lower Limit
        74.6
        upper Limit
        78.8
        value
        76.7
    title
    Year 7
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.1
        upper Limit
        70.7
        value
        68.4
      2. group Id
        OG001
        lower Limit
        72.9
        upper Limit
        77.2
        value
        75.1
      3. group Id
        OG002
        lower Limit
        73.6
        upper Limit
        77.9
        value
        75.8
    title
    Year 8
denoms
  1. counts
    1. group Id
      OG000
      value
      1697
    2. group Id
      OG001
      value
      1702
    3. group Id
      OG002
      value
      1700
    units
    Participants
description
RFS events included local, regional, or distant tumor recurrence. The percentage of participants free of RFS events (i.e., the RFS 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.
dispersion Type
95% Confidence Interval
groups
  1. 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
  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 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
  3. 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
Years 3, 5, 7, 8
title
RFS Rate According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice