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NCT01808573 · OUTCOME

Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting · 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.

What was measured

The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening. Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented.

Groups in this outcome

Neratinib Plus Capecitabine

neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.

Lapatinib Plus Capecitabine

lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.

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

Analysis denominator · Participants

GroupSource count
Neratinib Plus Capecitabine84
Lapatinib Plus Capecitabine72

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neratinib Plus Capecitabine8.54Not reported5.6211.17Not reported
Lapatinib Plus Capecitabine5.55Not reported4.216.41Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.332
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.736
    estimate Comment
    Lapatinib Plus Capecitabine is the reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    param Type
    Hazard Ratio (HR)
    param Value
    0.495
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.332
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.736
    estimate Comment
    Lapatinib Plus Capecitabine is the reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    param Type
    Hazard Ratio (HR)
    param Value
    0.495
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.62
        upper Limit
        11.17
        value
        8.54
      2. group Id
        OG001
        lower Limit
        4.21
        upper Limit
        6.41
        value
        5.55
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    2. group Id
      OG001
      value
      72
    units
    Participants
description
The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening. Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented.
dispersion Type
95% Confidence Interval
groups
  1. description
    neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    OG000
    title
    Neratinib Plus Capecitabine
  2. description
    lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    OG001
    title
    Lapatinib Plus Capecitabine
param Type
MEDIAN
reporting Status
POSTED
time Frame
From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.
title
Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice