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NCT00861705 · BASELINE

Baseline characteristics

Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery · Source last updated 2026-06-29

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
      115
    2. group Id
      BG001
      value
      113
    3. group Id
      BG002
      value
      113
    4. group Id
      BG003
      value
      113
    5. group Id
      BG004
      value
      454
    units
    Participants
groups
  1. description
    Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV
    id
    BG000
    title
    Arm 1 (Pac --> ddAC)
  2. description
    Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV
    id
    BG001
    title
    Arm 2 (Pac + Bev --> ddAC + Bev)
  3. description
    Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
    id
    BG002
    title
    Arm 3 (Pac + Carboplatin --> ddAC)
  4. description
    Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
    id
    BG003
    title
    Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.1
          value
          50.2
        2. group Id
          BG001
          spread
          10.8
          value
          48.3
        3. group Id
          BG002
          spread
          10.8
          value
          50.9
        4. group Id
          BG003
          spread
          9.8
          value
          47.1
        5. group Id
          BG004
          spread
          10.7
          value
          49.1
    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
          115
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          113
        4. group Id
          BG003
          value
          113
        5. group Id
          BG004
          value
          454
        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
        5. group Id
          BG004
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          89
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          80
        4. group Id
          BG003
          value
          81
        5. group Id
          BG004
          value
          331
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Using a modified intent-to-treat approach only patients who began protocol treatment (n=443) were included in analyses for neoadjuvant treatment and toxicity. Analyses for surgical endpoints excluded 10 patients who withdrew consent prior to surgery (n=433). All analyses considered patients according to treatment assignment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      115
    2. group Id
      BG001
      value
      113
    3. group Id
      BG002
      value
      113
    4. group Id
      BG003
      value
      113
    5. group Id
      BG004
      value
      454
    units
    Participants
groups
  1. description
    Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV
    id
    BG000
    title
    Arm 1 (Pac --> ddAC)
  2. description
    Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV
    id
    BG001
    title
    Arm 2 (Pac + Bev --> ddAC + Bev)
  3. description
    Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV carboplatin: Given IV
    id
    BG002
    title
    Arm 3 (Pac + Carboplatin --> ddAC)
  4. description
    Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3. doxorubicin hydrochloride: Given IV paclitaxel: Given IV cyclophosphamide: Given IV bevacizumab: Given IV carboplatin: Given IV
    id
    BG003
    title
    Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.1
          value
          50.2
        2. group Id
          BG001
          spread
          10.8
          value
          48.3
        3. group Id
          BG002
          spread
          10.8
          value
          50.9
        4. group Id
          BG003
          spread
          9.8
          value
          47.1
        5. group Id
          BG004
          spread
          10.7
          value
          49.1
    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
          115
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          113
        4. group Id
          BG003
          value
          113
        5. group Id
          BG004
          value
          454
        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
        5. group Id
          BG004
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          89
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          80
        4. group Id
          BG003
          value
          81
        5. group Id
          BG004
          value
          331
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Using a modified intent-to-treat approach only patients who began protocol treatment (n=443) were included in analyses for neoadjuvant treatment and toxicity. Analyses for surgical endpoints excluded 10 patients who withdrew consent prior to surgery (n=433). All analyses considered patients according to treatment assignment.

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Preserved source evidence · Not medical advice