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NCT00021255 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      1073
    2. group Id
      BG001
      value
      1074
    3. group Id
      BG002
      value
      1075
    4. group Id
      BG003
      value
      3222
    units
    Participants
groups
  1. 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 followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
    id
    BG000
    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
    BG001
    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
    BG002
    title
    Docetaxel + Carboplatin + Herceptin (TCH)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.7
          value
          48.8
        2. group Id
          BG001
          spread
          9.7
          value
          48.7
        3. group Id
          BG002
          spread
          9.9
          value
          48.6
        4. group Id
          BG003
          spread
          9.8
          value
          48.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1073
        2. group Id
          BG001
          value
          1074
        3. group Id
          BG002
          value
          1075
        4. group Id
          BG003
          value
          3222
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-To-Treat (ITT) population included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1073
    2. group Id
      BG001
      value
      1074
    3. group Id
      BG002
      value
      1075
    4. group Id
      BG003
      value
      3222
    units
    Participants
groups
  1. 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 followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
    id
    BG000
    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
    BG001
    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
    BG002
    title
    Docetaxel + Carboplatin + Herceptin (TCH)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.7
          value
          48.8
        2. group Id
          BG001
          spread
          9.7
          value
          48.7
        3. group Id
          BG002
          spread
          9.9
          value
          48.6
        4. group Id
          BG003
          spread
          9.8
          value
          48.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1073
        2. group Id
          BG001
          value
          1074
        3. group Id
          BG002
          value
          1075
        4. group Id
          BG003
          value
          3222
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Intent-To-Treat (ITT) population included all randomized participants.

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Preserved source evidence · Not medical advice