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NCT00045032 · OUTCOME

Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum 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 (maximum of 10 years)

What was measured

DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event 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

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

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Observation Arm35.8Not reportedNot reportedNot reportedNot reported
Herceptin 1-Year Arm29.7Not reportedNot reportedNot reportedNot reported
Herceptin 2-Year Arm30.5Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.68
    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
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
  2. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    estimate Comment
    HR for Herceptin 2-Year Arm versus Observation Arm.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.77
Complete source fields
analyses
  1. ci Lower Limit
    0.68
    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
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
  2. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    estimate Comment
    HR for Herceptin 2-Year Arm versus Observation Arm.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.77
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35.8
      2. group Id
        OG001
        value
        29.7
      3. group Id
        OG002
        value
        30.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1697
    2. group Id
      OG001
      value
      1702
    3. group Id
      OG002
      value
      1700
    units
    Participants
description
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
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
From Baseline until time of event (maximum of 10 years)
title
Percentage of Participants With DFS Events Compared to Observation: 10-Year Maximum Follow-Up
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice