Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01419197 · OUTCOME

Progression-free Survival

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 11 Feb 2013 (up to 2 years)

What was measured

Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.

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 Emtansine6.2Not reported5.596.87Not reported
Treatment of Physician's Choice3.3Not reported2.894.14Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.422
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.661
    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 vs no visceral disease).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.
    param Type
    Hazard Ratio (HR)
    param Value
    0.528
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.422
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.661
    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 vs no visceral disease).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.
    param Type
    Hazard Ratio (HR)
    param Value
    0.528
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.59
        upper Limit
        6.87
        value
        6.2
      2. group Id
        OG001
        lower Limit
        2.89
        upper Limit
        4.14
        value
        3.3
denoms
  1. counts
    1. group Id
      OG000
      value
      404
    2. group Id
      OG001
      value
      198
    units
    Participants
description
Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.
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 11 Feb 2013 (up to 2 years)
title
Progression-free Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice