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NCT02492711 · OUTCOME

Progression-free Survival (PFS) as Determined by Independent Radiological Review.

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer · Source last updated 2025-03-17

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
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.

What was measured

PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.

Analysis population: The PFS outcome measure is calculated only for the randomized study efficacy population. The 88 participants in the sub-study were not part of the efficacy population

Groups in this outcome

Margetuximab Plus Chemotherapy

Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.

Trastuzumab Plus Chemotherapy

Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.

Margetuximab Infusion Substudy

Margetuximab with or without chemotherap...

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

Analysis denominator · Participants

GroupSource count
Margetuximab Plus Chemotherapy266
Trastuzumab Plus Chemotherapy270
Margetuximab Infusion Substudy0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Margetuximab Plus Chemotherapy5.8Not reported5.526.97Not reported
Trastuzumab Plus Chemotherapy4.9Not reported4.175.59Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.593
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.979
    estimate Comment
    Stratified Cox Proportional Model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0334
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
    statistical Comment
    Stratified Log-Rank Test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.593
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.979
    estimate Comment
    Stratified Cox Proportional Model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0334
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
    statistical Comment
    Stratified Log-Rank Test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.52
        upper Limit
        6.97
        value
        5.8
      2. group Id
        OG001
        lower Limit
        4.17
        upper Limit
        5.59
        value
        4.9
denoms
  1. counts
    1. group Id
      OG000
      value
      266
    2. group Id
      OG001
      value
      270
    3. group Id
      OG002
      value
      0
    units
    Participants
description
PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    OG000
    title
    Margetuximab Plus Chemotherapy
  2. description
    Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    OG001
    title
    Trastuzumab Plus Chemotherapy
  3. description
    Margetuximab with or without chemotherap...
    id
    OG002
    title
    Margetuximab Infusion Substudy
param Type
MEDIAN
population Description
The PFS outcome measure is calculated only for the randomized study efficacy population. The 88 participants in the sub-study were not part of the efficacy population
reporting Status
POSTED
time Frame
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.
title
Progression-free Survival (PFS) as Determined by Independent Radiological Review.
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice