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NCT00878709 · OUTCOME

Overall Survival (OS)

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer · Source last updated 2021-06-11

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
Randomization until death due to any cause (up to 119 Months)

What was measured

OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.

Analysis population: Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Groups in this outcome

Neratinib

Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Placebo

Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Neratinib1420
Placebo1420

Reported measurements

1 Year Kaplan-Meier Estimate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neratinib99.64Not reported99.1399.85Not reported
Placebo99.43Not reported98.8699.71Not reported
3 Year Kaplan-Meier Estimate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neratinib96.74Not reported95.6297.57Not reported
Placebo96.44Not reported95.3097.31Not reported
5 Year Kaplan-Meier Estimate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neratinib94.09Not reported92.6595.25Not reported
Placebo93.26Not reported91.7794.49Not reported
7 Year Kaplan-Meier Estimate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neratinib91.36Not reported89.6692.79Not reported
Placebo91.29Not reported89.6292.70Not reported
9 Year Kaplan-Meier Estimate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neratinib89.06Not reported86.9790.84Not reported
Placebo88.65Not reported88.5890.43Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.747
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.212
    group Description
    The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6914
    param Type
    Hazard Ratio (HR)
    param Value
    0.952
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.747
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.212
    group Description
    The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6914
    param Type
    Hazard Ratio (HR)
    param Value
    0.952
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.13
        upper Limit
        99.85
        value
        99.64
      2. group Id
        OG001
        lower Limit
        98.86
        upper Limit
        99.71
        value
        99.43
    title
    1 Year Kaplan-Meier Estimate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        95.62
        upper Limit
        97.57
        value
        96.74
      2. group Id
        OG001
        lower Limit
        95.30
        upper Limit
        97.31
        value
        96.44
    title
    3 Year Kaplan-Meier Estimate
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.65
        upper Limit
        95.25
        value
        94.09
      2. group Id
        OG001
        lower Limit
        91.77
        upper Limit
        94.49
        value
        93.26
    title
    5 Year Kaplan-Meier Estimate
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.66
        upper Limit
        92.79
        value
        91.36
      2. group Id
        OG001
        lower Limit
        89.62
        upper Limit
        92.70
        value
        91.29
    title
    7 Year Kaplan-Meier Estimate
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.97
        upper Limit
        90.84
        value
        89.06
      2. group Id
        OG001
        lower Limit
        88.58
        upper Limit
        90.43
        value
        88.65
    title
    9 Year Kaplan-Meier Estimate
denoms
  1. counts
    1. group Id
      OG000
      value
      1420
    2. group Id
      OG001
      value
      1420
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
    id
    OG000
    title
    Neratinib
  2. description
    Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year.Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.
reporting Status
POSTED
time Frame
Randomization until death due to any cause (up to 119 Months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice