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NCT02492711 · OUTCOME

To Evaluate the Objective Response Rate (ORR) 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.

What was measured

Objective response rate includes all patients with either a complete response (CR) or a partial response (PR) to study treatment

Analysis population: Tumor response was assessed for patients with measurable disease at baseline. The cutoff data for analysis corresponds with the completion of enrollment. Detection of ORR requires at least 12 weeks, so the ORR may be underestimated. Outcome measure is calculated only for the randomized study 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 chemotherapy

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 Chemotherapy262
Trastuzumab Plus Chemotherapy262
Margetuximab Infusion Substudy0

Reported measurements

Source class 1

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Margetuximab Plus Chemotherapy7Not reportedNot reportedNot reportedNot reported
Trastuzumab Plus Chemotherapy4Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Margetuximab Plus Chemotherapy51Not reportedNot reportedNot reportedNot reported
Trastuzumab Plus Chemotherapy38Not reportedNot reportedNot reportedNot reported

No response, progressive disease, not evaluable or not available

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Margetuximab Plus Chemotherapy204Not reportedNot reportedNot reportedNot reported
Trastuzumab Plus Chemotherapy220Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
      title
      CR
    2. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        38
      title
      PR
    3. measurements
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        220
      title
      No response, progressive disease, not evaluable or not available
denoms
  1. counts
    1. group Id
      OG000
      value
      262
    2. group Id
      OG001
      value
      262
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Objective response rate includes all patients with either a complete response (CR) or a partial response (PR) to study treatment
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 chemotherapy
    id
    OG002
    title
    Margetuximab Infusion Substudy
param Type
COUNT_OF_PARTICIPANTS
population Description
Tumor response was assessed for patients with measurable disease at baseline. The cutoff data for analysis corresponds with the completion of enrollment. Detection of ORR requires at least 12 weeks, so the ORR may be underestimated. Outcome measure is calculated only for the randomized study 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, up to 6.5 years.
title
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice