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NCT00950300 · FLOW

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A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer · Source last updated 2018-01-23

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

groups
  1. description
    Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m\^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m\^2, epirubicin 75 mg/m\^2, and cyclophosphamide 500 mg/m\^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
    id
    FG000
    title
    Herceptin IV + Chemotherapy
  2. description
    Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
    id
    FG001
    title
    Herceptin SC + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        15
      type
      Adverse Event or Intercurrent Illness
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Insufficient Therapeutic Response
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Violation of Selection Criteria
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Participant Refusal/Withdrawal
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        11
      type
      Progression of Disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      type
      Recurrence of Disease
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        299
      2. group Id
        FG001
        num Subjects
        297
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        298
      2. group Id
        FG001
        num Subjects
        297
      type
      Received Neoadjuvant Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        273
      type
      Underwent Surgery
    4. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        274
      type
      Entered Adjuvant Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        257
      2. group Id
        FG001
        num Subjects
        255
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Neoadjuvant/Adjuvant Treatment Periods
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event or Intercurrent Illness
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        11
      type
      Refused Treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      Failure to Return
    5. reasons
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        72
      type
      Recurrence of Disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      Other
    milestones
    1. achievements
      1. comment
        Participants could withdraw from the study entirely or advance directly to the TFFU or SFU Period.
        group Id
        FG000
        num Subjects
        265
      2. comment
        Participants could withdraw from the study entirely or advance directly to the TFFU or SFU Period.
        group Id
        FG001
        num Subjects
        268
      type
      STARTED
    2. achievements
      1. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG000
        num Subjects
        165
      2. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG001
        num Subjects
        161
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        107
      type
      NOT COMPLETED
    title
    TFFU Period
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        44
      2. group Id
        FG001
        num Subjects
        42
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        28
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        Participants could withdraw from the study entirely or advance directly to the SFU Period.
        group Id
        FG000
        num Subjects
        118
      2. comment
        Participants could withdraw from the study entirely or advance directly to the SFU Period.
        group Id
        FG001
        num Subjects
        123
      type
      STARTED
    2. achievements
      1. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG000
        num Subjects
        40
      2. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG001
        num Subjects
        45
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        78
      type
      NOT COMPLETED
    title
    SFU Period
pre Assignment Details
A total of 833 participants were screened, out of which, 596 participants were enrolled into the study.
Complete source fields
groups
  1. description
    Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m\^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m\^2, epirubicin 75 mg/m\^2, and cyclophosphamide 500 mg/m\^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
    id
    FG000
    title
    Herceptin IV + Chemotherapy
  2. description
    Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
    id
    FG001
    title
    Herceptin SC + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        15
      type
      Adverse Event or Intercurrent Illness
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Insufficient Therapeutic Response
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Violation of Selection Criteria
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      type
      Participant Refusal/Withdrawal
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        11
      type
      Progression of Disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      type
      Recurrence of Disease
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        299
      2. group Id
        FG001
        num Subjects
        297
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        298
      2. group Id
        FG001
        num Subjects
        297
      type
      Received Neoadjuvant Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        273
      type
      Underwent Surgery
    4. achievements
      1. group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        274
      type
      Entered Adjuvant Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        257
      2. group Id
        FG001
        num Subjects
        255
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Neoadjuvant/Adjuvant Treatment Periods
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Adverse Event or Intercurrent Illness
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        11
      type
      Refused Treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      Failure to Return
    5. reasons
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        72
      type
      Recurrence of Disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      Other
    milestones
    1. achievements
      1. comment
        Participants could withdraw from the study entirely or advance directly to the TFFU or SFU Period.
        group Id
        FG000
        num Subjects
        265
      2. comment
        Participants could withdraw from the study entirely or advance directly to the TFFU or SFU Period.
        group Id
        FG001
        num Subjects
        268
      type
      STARTED
    2. achievements
      1. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG000
        num Subjects
        165
      2. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG001
        num Subjects
        161
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        107
      type
      NOT COMPLETED
    title
    TFFU Period
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        44
      2. group Id
        FG001
        num Subjects
        42
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        28
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        Participants could withdraw from the study entirely or advance directly to the SFU Period.
        group Id
        FG000
        num Subjects
        118
      2. comment
        Participants could withdraw from the study entirely or advance directly to the SFU Period.
        group Id
        FG001
        num Subjects
        123
      type
      STARTED
    2. achievements
      1. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG000
        num Subjects
        40
      2. comment
        Includes participants who completed either 2 years of follow-up or 5 years of follow-up.
        group Id
        FG001
        num Subjects
        45
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        78
      type
      NOT COMPLETED
    title
    SFU Period
pre Assignment Details
A total of 833 participants were screened, out of which, 596 participants were enrolled into the study.

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Preserved source evidence · Not medical advice