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NCT00878709 · OUTCOME

Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2

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 with events
Interval / dispersion
Not reported
Time frame
From randomization until time of event up to 2 years

What was measured

Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

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

Source class 1
Values in percentage of participants with events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neratinib4.7Not reportedNot reportedNot reportedNot reported
Placebo7.5Not 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
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).
    group Description
    Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.008
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
    statistical Comment
    The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).
    group Description
    Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.008
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
    statistical Comment
    The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4.7
      2. group Id
        OG001
        value
        7.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1420
    2. group Id
      OG001
      value
      1420
    units
    Participants
description
Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
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
From randomization until time of event up to 2 years
title
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
type
PRIMARY
unit Of Measure
percentage of participants with events

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

Preserved source evidence · Not medical advice