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NCT01419197 · OUTCOME

Overall Survival (Final Analysis)

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy · Source last updated 2016-10-12

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
Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)

What was measured

Overall survival was defined as the time from randomization to death from any cause.

Analysis population: Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Trastuzumab Emtansine

Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

Treatment of Physician's Choice

Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.

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 Emtansine404
Treatment of Physician's Choice198

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab Emtansine22.7Not reported19.3527.47Not reported
Treatment of Physician's Choice15.8Not reported13.5018.66Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.539
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.850
    estimate Comment
    The hazard ratio was estimated by Cox regression.
    group Description
    The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0007
    p Value Comment
    The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).
    param Type
    Hazard Ratio (HR)
    param Value
    0.677
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.539
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.850
    estimate Comment
    The hazard ratio was estimated by Cox regression.
    group Description
    The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0007
    p Value Comment
    The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).
    param Type
    Hazard Ratio (HR)
    param Value
    0.677
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.35
        upper Limit
        27.47
        value
        22.7
      2. group Id
        OG001
        lower Limit
        13.50
        upper Limit
        18.66
        value
        15.8
denoms
  1. counts
    1. group Id
      OG000
      value
      404
    2. group Id
      OG001
      value
      198
    units
    Participants
description
Overall survival was defined as the time from randomization to death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    id
    OG000
    title
    Trastuzumab Emtansine
  2. description
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    id
    OG001
    title
    Treatment of Physician's Choice
param Type
MEDIAN
population Description
Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)
title
Overall Survival (Final Analysis)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice