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NCT00021255 · FLOW

Participant flow

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer · Source last updated 2016-11-15

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

groups
  1. description
    Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
    id
    FG000
    title
    Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
  2. description
    Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
    id
    FG001
    title
    AC Followed by Docetaxel + Herceptin (AC→TH)
  3. description
    Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
    id
    FG002
    title
    Docetaxel + Carboplatin + Herceptin (TCH)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        11
      type
      Breast cancer relapse
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Second primary malignancy
    4. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        64
      3. group Id
        FG002
        num Subjects
        26
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        61
      3. group Id
        FG002
        num Subjects
        32
      type
      Cardiac toxicity
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        6
      type
      Herceptin toxicity
    8. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        18
      type
      Adverse Event
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        19
      type
      Other than specified above
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        13
      type
      Missing
    12. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        18
      type
      Randomized but not treated
    milestones
    1. achievements
      1. comment
        Randomized
        group Id
        FG000
        num Subjects
        1073
      2. comment
        Randomized
        group Id
        FG001
        num Subjects
        1074
      3. comment
        Randomized
        group Id
        FG002
        num Subjects
        1075
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1045
      2. group Id
        FG001
        num Subjects
        1072
      3. group Id
        FG002
        num Subjects
        1057
      type
      Treated
    3. achievements
      1. comment
        1018 participants received AC-T (1012 from AC-T arm, 6 from AC-TH arm).
        group Id
        FG000
        num Subjects
        1018
      2. comment
        1100 participants received AC-TH (1066 from AC-TH arm, 33 from AC-T arm and 1 from TCH arm).
        group Id
        FG001
        num Subjects
        1100
      3. comment
        1056 participants received TCH.
        group Id
        FG002
        num Subjects
        1056
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        952
      2. group Id
        FG001
        num Subjects
        804
      3. group Id
        FG002
        num Subjects
        926
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        121
      2. group Id
        FG001
        num Subjects
        270
      3. group Id
        FG002
        num Subjects
        149
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized in 1:1:1 ratio to receive adjuvant therapy with either AC→ T, AC→ TH or TCH. During the course of the study, some participants received treatment different from the arm in which they were randomized. The safety analyses was conducted as per the treatment received.
recruitment Details
The study was conducted at 433 centers in 43 countries. A total of 3222 participants randomized between 05 April 2001 and 30 March 2004. Participants stratified according to institution, nodal status(negative, positive 1-3 nodes, positive 4 or more nodes) and hormonal receptor status (estrogen and/or progesterone receptor positive versus negative).
Complete source fields
groups
  1. description
    Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
    id
    FG000
    title
    Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
  2. description
    Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
    id
    FG001
    title
    AC Followed by Docetaxel + Herceptin (AC→TH)
  3. description
    Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
    id
    FG002
    title
    Docetaxel + Carboplatin + Herceptin (TCH)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        11
      type
      Breast cancer relapse
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Second primary malignancy
    4. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        64
      3. group Id
        FG002
        num Subjects
        26
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        61
      3. group Id
        FG002
        num Subjects
        32
      type
      Cardiac toxicity
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        6
      type
      Herceptin toxicity
    8. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        18
      type
      Adverse Event
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        19
      type
      Other than specified above
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        13
      type
      Missing
    12. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        18
      type
      Randomized but not treated
    milestones
    1. achievements
      1. comment
        Randomized
        group Id
        FG000
        num Subjects
        1073
      2. comment
        Randomized
        group Id
        FG001
        num Subjects
        1074
      3. comment
        Randomized
        group Id
        FG002
        num Subjects
        1075
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1045
      2. group Id
        FG001
        num Subjects
        1072
      3. group Id
        FG002
        num Subjects
        1057
      type
      Treated
    3. achievements
      1. comment
        1018 participants received AC-T (1012 from AC-T arm, 6 from AC-TH arm).
        group Id
        FG000
        num Subjects
        1018
      2. comment
        1100 participants received AC-TH (1066 from AC-TH arm, 33 from AC-T arm and 1 from TCH arm).
        group Id
        FG001
        num Subjects
        1100
      3. comment
        1056 participants received TCH.
        group Id
        FG002
        num Subjects
        1056
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        952
      2. group Id
        FG001
        num Subjects
        804
      3. group Id
        FG002
        num Subjects
        926
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        121
      2. group Id
        FG001
        num Subjects
        270
      3. group Id
        FG002
        num Subjects
        149
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized in 1:1:1 ratio to receive adjuvant therapy with either AC→ T, AC→ TH or TCH. During the course of the study, some participants received treatment different from the arm in which they were randomized. The safety analyses was conducted as per the treatment received.
recruitment Details
The study was conducted at 433 centers in 43 countries. A total of 3222 participants randomized between 05 April 2001 and 30 March 2004. Participants stratified according to institution, nodal status(negative, positive 1-3 nodes, positive 4 or more nodes) and hormonal receptor status (estrogen and/or progesterone receptor positive versus negative).

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Preserved source evidence · Not medical advice