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NCT01401166 · FLOW

Participant flow

Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer · Source last updated 2017-03-06

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

groups
  1. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
    id
    FG000
    title
    Cohort 1: SC (SID) Then IV Herceptin
  2. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
    id
    FG001
    title
    Cohort 1: IV Then SC (SID) Herceptin
  3. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
    id
    FG002
    title
    Cohort 2: SC (Vial) Then IV Herceptin
  4. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
    id
    FG003
    title
    Cohort 2: IV Then SC (Vial) Herceptin
periods
  1. milestones
    1. achievements
      1. comment
        A total of 124 participants were randomized, but 2 did not receive any treatment.
        group Id
        FG000
        num Subjects
        122
      2. comment
        A total of 124 participants were randomized, but 2 did not receive any treatment.
        group Id
        FG001
        num Subjects
        122
      3. comment
        A total of 121 participants were randomized who all received study treatment.
        group Id
        FG002
        num Subjects
        121
      4. comment
        A total of 119 participants were randomized, but 1 did not receive any treatment.
        group Id
        FG003
        num Subjects
        118
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        119
      4. group Id
        FG003
        num Subjects
        116
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Crossover Treatment 1 (Cycles 1 to 4)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        119
      4. group Id
        FG003
        num Subjects
        116
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        116
      3. group Id
        FG002
        num Subjects
        107
      4. group Id
        FG003
        num Subjects
        105
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Crossover Treatment 2 (Cycles 5 to 8)
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        116
      3. group Id
        FG002
        num Subjects
        107
      4. group Id
        FG003
        num Subjects
        105
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        109
      3. group Id
        FG002
        num Subjects
        105
      4. group Id
        FG003
        num Subjects
        102
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Continuation Treatment (Cycles 9 to 18)
  4. milestones
    1. achievements
      1. comment
        All 124 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG000
        num Subjects
        124
      2. comment
        All 124 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG001
        num Subjects
        124
      3. comment
        All 121 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG002
        num Subjects
        121
      4. comment
        All 119 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG003
        num Subjects
        119
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        106
      3. group Id
        FG002
        num Subjects
        104
      4. group Id
        FG003
        num Subjects
        100
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Safety Follow-Up Period
pre Assignment Details
A total of 248 participants were randomized into the study in Cohort 1 (of whom 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of whom 239 were treated). Those participants who did not receive any treatment were not included in the treatment periods of the Participant Flow.
Complete source fields
groups
  1. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
    id
    FG000
    title
    Cohort 1: SC (SID) Then IV Herceptin
  2. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
    id
    FG001
    title
    Cohort 1: IV Then SC (SID) Herceptin
  3. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
    id
    FG002
    title
    Cohort 2: SC (Vial) Then IV Herceptin
  4. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
    id
    FG003
    title
    Cohort 2: IV Then SC (Vial) Herceptin
periods
  1. milestones
    1. achievements
      1. comment
        A total of 124 participants were randomized, but 2 did not receive any treatment.
        group Id
        FG000
        num Subjects
        122
      2. comment
        A total of 124 participants were randomized, but 2 did not receive any treatment.
        group Id
        FG001
        num Subjects
        122
      3. comment
        A total of 121 participants were randomized who all received study treatment.
        group Id
        FG002
        num Subjects
        121
      4. comment
        A total of 119 participants were randomized, but 1 did not receive any treatment.
        group Id
        FG003
        num Subjects
        118
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        119
      4. group Id
        FG003
        num Subjects
        116
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Crossover Treatment 1 (Cycles 1 to 4)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        120
      3. group Id
        FG002
        num Subjects
        119
      4. group Id
        FG003
        num Subjects
        116
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        116
      3. group Id
        FG002
        num Subjects
        107
      4. group Id
        FG003
        num Subjects
        105
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        12
      4. group Id
        FG003
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Crossover Treatment 2 (Cycles 5 to 8)
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        113
      2. group Id
        FG001
        num Subjects
        116
      3. group Id
        FG002
        num Subjects
        107
      4. group Id
        FG003
        num Subjects
        105
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        109
      3. group Id
        FG002
        num Subjects
        105
      4. group Id
        FG003
        num Subjects
        102
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Continuation Treatment (Cycles 9 to 18)
  4. milestones
    1. achievements
      1. comment
        All 124 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG000
        num Subjects
        124
      2. comment
        All 124 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG001
        num Subjects
        124
      3. comment
        All 121 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG002
        num Subjects
        121
      4. comment
        All 119 randomized participants entered follow-up regardless of whether they received treatment.
        group Id
        FG003
        num Subjects
        119
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        99
      2. group Id
        FG001
        num Subjects
        106
      3. group Id
        FG002
        num Subjects
        104
      4. group Id
        FG003
        num Subjects
        100
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        19
      type
      NOT COMPLETED
    title
    Safety Follow-Up Period
pre Assignment Details
A total of 248 participants were randomized into the study in Cohort 1 (of whom 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of whom 239 were treated). Those participants who did not receive any treatment were not included in the treatment periods of the Participant Flow.

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Preserved source evidence · Not medical advice