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NCT00829166 · OUTCOME

Percentage of Participants With Objective Response (OR) as Assessed by an IRC

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer · Source last updated 2016-10-31

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
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

What was measured

Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as \>/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.

Analysis population: ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.

Groups in this outcome

Trastuzumab Emtansine

Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.

Lapatinib + Capecitabine

Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab Emtansine397
Lapatinib + Capecitabine389

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine43.6Not reported38.648.6Not reported
Lapatinib + Capecitabine30.8Not reported26.335.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    6.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.4
    estimate Comment
    The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.
    group Description
    Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    param Type
    Difference in Objective Response Rates
    param Value
    12.7
    statistical Method
    Mantel-Haenszel chi-squared test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    6.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.4
    estimate Comment
    The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.
    group Description
    Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0002
    param Type
    Difference in Objective Response Rates
    param Value
    12.7
    statistical Method
    Mantel-Haenszel chi-squared test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.6
        upper Limit
        48.6
        value
        43.6
      2. group Id
        OG001
        lower Limit
        26.3
        upper Limit
        35.7
        value
        30.8
denoms
  1. counts
    1. group Id
      OG000
      value
      397
    2. group Id
      OG001
      value
      389
    units
    Participants
description
Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as \>/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
    id
    OG000
    title
    Trastuzumab Emtansine
  2. description
    Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
    id
    OG001
    title
    Lapatinib + Capecitabine
param Type
NUMBER
population Description
ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.
reporting Status
POSTED
time Frame
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
title
Percentage of Participants With Objective Response (OR) as Assessed by an IRC
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice