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NCT00567190 · OUTCOME

Baseline LVEF Value and Change in LVEF From Baseline at Maximum Absolute Decrease Value During the Treatment Period

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Percentage points of LVEF
Interval / dispersion
Standard Deviation
Time frame
Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks)

What was measured

All participants were required to have a left ventricular ejection fraction (LVEF) ≥50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Only data reported prior to the date of first crossover treatment were included for participants who crossed over from placebo to pertuzumab.

Analysis population: Safety Population: All participants who received at least one dose of any study medication. Only participants with evaluable LVEF assessments at baseline (BL) or at BL and post-BL (for change in LVEF from BL at max. decrease) were included in the analyses.

Groups in this outcome

Placebo + Trastuzumab + Docetaxel

This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

Pertuzumab + Trastuzumab + Docetaxel

This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, 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
Placebo + Trastuzumab + Docetaxel396
Pertuzumab + Trastuzumab + Docetaxel408

Reported measurements

Baseline (BL) LVEF Value

Analysis denominator · Participants

GroupSource count
Placebo + Trastuzumab + Docetaxel393
Pertuzumab + Trastuzumab + Docetaxel406
Values in Percentage points of LVEF · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo + Trastuzumab + Docetaxel65.66.51Not reportedNot reportedNot reported
Pertuzumab + Trastuzumab + Docetaxel64.86.71Not reportedNot reportedNot reported
Change in LVEF From BL at Maximum Decrease Value

Analysis denominator · Participants

GroupSource count
Placebo + Trastuzumab + Docetaxel375
Pertuzumab + Trastuzumab + Docetaxel392
Values in Percentage points of LVEF · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo + Trastuzumab + Docetaxel-7.37.15Not reportedNot reportedNot reported
Pertuzumab + Trastuzumab + Docetaxel-7.57.75Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Wilcoxon Test of Maximum Decrease in LVEF From BL
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.7174
    statistical Method
    Wilcoxon Rank Sum Test
Complete source fields
analyses
  1. group Description
    Wilcoxon Test of Maximum Decrease in LVEF From BL
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.7174
    statistical Method
    Wilcoxon Rank Sum Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.51
        value
        65.6
      2. group Id
        OG001
        spread
        6.71
        value
        64.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        393
      2. group Id
        OG001
        value
        406
      units
      Participants
    title
    Baseline (BL) LVEF Value
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.15
        value
        -7.3
      2. group Id
        OG001
        spread
        7.75
        value
        -7.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        375
      2. group Id
        OG001
        value
        392
      units
      Participants
    title
    Change in LVEF From BL at Maximum Decrease Value
denoms
  1. counts
    1. group Id
      OG000
      value
      396
    2. group Id
      OG001
      value
      408
    units
    Participants
description
All participants were required to have a left ventricular ejection fraction (LVEF) ≥50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Only data reported prior to the date of first crossover treatment were included for participants who crossed over from placebo to pertuzumab.
dispersion Type
Standard Deviation
groups
  1. description
    This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    OG000
    title
    Placebo + Trastuzumab + Docetaxel
  2. description
    This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    OG001
    title
    Pertuzumab + Trastuzumab + Docetaxel
param Type
MEAN
population Description
Safety Population: All participants who received at least one dose of any study medication. Only participants with evaluable LVEF assessments at baseline (BL) or at BL and post-BL (for change in LVEF from BL at max. decrease) were included in the analyses.
reporting Status
POSTED
time Frame
Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks)
title
Baseline LVEF Value and Change in LVEF From Baseline at Maximum Absolute Decrease Value During the Treatment Period
type
SECONDARY
unit Of Measure
Percentage points of LVEF

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

Preserved source evidence · Not medical advice