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NCT01120184 · OUTCOME

Overall Survival (OS) at Clinical Cutoff

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) · Source last updated 2024-03-04

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
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)

What was measured

OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.

Analysis population: ITT Population.

Groups in this outcome

Trastuzumab + Taxane

Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.

Trastuzumab Emtansine + Placebo

Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.

Trastuzumab Emtansine + Pertuzumab

Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.

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 + Taxane365
Trastuzumab Emtansine + Placebo367
Trastuzumab Emtansine + Pertuzumab363

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trastuzumab + Taxane50.86Not reported44.7560.75Not reported
Trastuzumab Emtansine + Placebo53.68Not reported48.3664.36Not reported
Trastuzumab Emtansine + Pertuzumab51.78Not reported47.87NAUpper limit of CI was not reached due to low number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.20
    estimate Comment
    Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane
    group Description
    Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.6568
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.11
    estimate Comment
    Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane
    group Description
    Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.5691
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.20
    estimate Comment
    Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane
    group Description
    Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.6568
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.11
    estimate Comment
    Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane
    group Description
    Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.5691
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.75
        upper Limit
        60.75
        value
        50.86
      2. group Id
        OG001
        lower Limit
        48.36
        upper Limit
        64.36
        value
        53.68
      3. comment
        Upper limit of CI was not reached due to low number of participants with events.
        group Id
        OG002
        lower Limit
        47.87
        upper Limit
        NA
        value
        51.78
denoms
  1. counts
    1. group Id
      OG000
      value
      365
    2. group Id
      OG001
      value
      367
    3. group Id
      OG002
      value
      363
    units
    Participants
description
OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
    id
    OG000
    title
    Trastuzumab + Taxane
  2. description
    Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
    id
    OG001
    title
    Trastuzumab Emtansine + Placebo
  3. description
    Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
    id
    OG002
    title
    Trastuzumab Emtansine + Pertuzumab
param Type
MEDIAN
population Description
ITT Population.
reporting Status
POSTED
time Frame
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
title
Overall Survival (OS) at Clinical Cutoff
type
SECONDARY
unit Of Measure
months

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