Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00567190 · BASELINE

Baseline characteristics

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

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
      402
    2. group Id
      BG001
      value
      406
    3. group Id
      BG002
      value
      808
    units
    Participants
groups
  1. description
    Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    BG000
    title
    Pertuzumab + Trastuzumab + Docetaxel
  2. description
    Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    BG001
    title
    Placebo + Trastuzumab + Docetaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.94
          value
          53.4
        2. group Id
          BG001
          spread
          11.35
          value
          53.5
        3. group Id
          BG002
          spread
          11.14
          value
          53.5
    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
          402
        2. group Id
          BG001
          value
          404
        3. group Id
          BG002
          value
          806
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        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
          39
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          362
        2. group Id
          BG001
          value
          362
        3. group Id
          BG002
          value
          724
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          261
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          30
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          480
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          30
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          253
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          306
        title
        Europe
      3. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          135
        title
        North America
      4. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          114
        title
        South America
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          376
        title
        Adjuvant or Neo-Adjuvant Therapy
      2. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          432
        title
        De Novo
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Treatment Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          343
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          679
        title
        Measurable Disease
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          87
        title
        Non-Measurable Disease
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          42
        title
        Not Evaluated
    description
    A participant was deemed to have measurable disease if they had at least 1 target lesion at screening. Target lesions (maximum of 5 per organ and 10 in total) were selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). Any participants with non-target lesions only were deemed to have non-measurable disease. The IRF did not evaluate baseline tumor assessments for any participant without a post-baseline tumor assessment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Independent-Review Facility (IRF)-Determined Disease Status at Screening
    unit Of Measure
    Participants
population Description
ITT population
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      402
    2. group Id
      BG001
      value
      406
    3. group Id
      BG002
      value
      808
    units
    Participants
groups
  1. description
    Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    BG000
    title
    Pertuzumab + Trastuzumab + Docetaxel
  2. description
    Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    BG001
    title
    Placebo + Trastuzumab + Docetaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.94
          value
          53.4
        2. group Id
          BG001
          spread
          11.35
          value
          53.5
        3. group Id
          BG002
          spread
          11.14
          value
          53.5
    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
          402
        2. group Id
          BG001
          value
          404
        3. group Id
          BG002
          value
          806
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        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
          39
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          362
        2. group Id
          BG001
          value
          362
        3. group Id
          BG002
          value
          724
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          261
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          30
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          480
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          30
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          253
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          306
        title
        Europe
      3. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          135
        title
        North America
      4. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          114
        title
        South America
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          376
        title
        Adjuvant or Neo-Adjuvant Therapy
      2. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          432
        title
        De Novo
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Treatment Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          343
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          679
        title
        Measurable Disease
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          87
        title
        Non-Measurable Disease
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          42
        title
        Not Evaluated
    description
    A participant was deemed to have measurable disease if they had at least 1 target lesion at screening. Target lesions (maximum of 5 per organ and 10 in total) were selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). Any participants with non-target lesions only were deemed to have non-measurable disease. The IRF did not evaluate baseline tumor assessments for any participant without a post-baseline tumor assessment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Independent-Review Facility (IRF)-Determined Disease Status at Screening
    unit Of Measure
    Participants
population Description
ITT population

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice