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NCT02492711 · FLOW

Participant flow

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.

groups
  1. description
    Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    FG000
    title
    Margetuximab Plus Chemotherapy
  2. description
    Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    FG001
    title
    Trastuzumab Plus Chemotherapy
  3. description
    Margetuximab with or without chemotherapy administered as a 120 minute first infusion in Cycle 1 followed by 60-minute or 30-minute infusion in Cycle 2.
    id
    FG002
    title
    Margetuximab Infusion Substudy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      study treatment delay
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      change in chemotherapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      never treated
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        266
      2. group Id
        FG001
        num Subjects
        270
      3. group Id
        FG002
        num Subjects
        88
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        266
      2. group Id
        FG001
        num Subjects
        270
      3. group Id
        FG002
        num Subjects
        88
      type
      Intent-to-treat (ITT) Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        264
      2. group Id
        FG001
        num Subjects
        266
      3. group Id
        FG002
        num Subjects
        88
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        230
      2. group Id
        FG001
        num Subjects
        230
      3. group Id
        FG002
        num Subjects
        75
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Margetuximab 15 mg/kg administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    FG000
    title
    Margetuximab Plus Chemotherapy
  2. description
    Trastuzumab administered every 21 days with physician's choice of 1 of 4 backbone chemotherapy regimens.
    id
    FG001
    title
    Trastuzumab Plus Chemotherapy
  3. description
    Margetuximab with or without chemotherapy administered as a 120 minute first infusion in Cycle 1 followed by 60-minute or 30-minute infusion in Cycle 2.
    id
    FG002
    title
    Margetuximab Infusion Substudy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        16
      3. group Id
        FG002
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      study treatment delay
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      change in chemotherapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      never treated
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        266
      2. group Id
        FG001
        num Subjects
        270
      3. group Id
        FG002
        num Subjects
        88
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        266
      2. group Id
        FG001
        num Subjects
        270
      3. group Id
        FG002
        num Subjects
        88
      type
      Intent-to-treat (ITT) Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        264
      2. group Id
        FG001
        num Subjects
        266
      3. group Id
        FG002
        num Subjects
        88
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        230
      2. group Id
        FG001
        num Subjects
        230
      3. group Id
        FG002
        num Subjects
        75
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice