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NCT03043313 · BASELINE

Baseline characteristics

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer · Source last updated 2024-11-26

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
      45
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      30
    4. group Id
      BG003
      value
      114
    units
    Participants
groups
  1. description
    Non-randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    BG000
    title
    Tucatinib+Trastuzumab (Cohort A)
  2. description
    Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    BG001
    title
    Tucatinib+Trastuzumab (Cohort B)
  3. description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
    id
    BG002
    title
    Tucatinib Monotherapy (Cohort C)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          71
          value
          52
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          77
          value
          57
        3. group Id
          BG002
          lower Limit
          29
          upper Limit
          75
          value
          59.5
        4. group Id
          BG003
          lower Limit
          24
          upper Limit
          77
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          66
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          89
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          21
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          88
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        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
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          67
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          44
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Grade 2
    description
    ECOG performance status was used to assess participants disease progression, and ability to carry out daily living activities. 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed less than (\<)50 percent (%) of the time; 3= In bed \>50% of the time; 4=100% bedridden; 5=Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          85
        title
        North America
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          29
        title
        Europe
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had human epidermal growth factor receptor 2+ (HER2+) tumors as defined by one or more protocol required local tests.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      45
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      30
    4. group Id
      BG003
      value
      114
    units
    Participants
groups
  1. description
    Non-randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    BG000
    title
    Tucatinib+Trastuzumab (Cohort A)
  2. description
    Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
    id
    BG001
    title
    Tucatinib+Trastuzumab (Cohort B)
  3. description
    Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
    id
    BG002
    title
    Tucatinib Monotherapy (Cohort C)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          71
          value
          52
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          77
          value
          57
        3. group Id
          BG002
          lower Limit
          29
          upper Limit
          75
          value
          59.5
        4. group Id
          BG003
          lower Limit
          24
          upper Limit
          77
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          66
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          89
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          21
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          88
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        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
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          67
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          44
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Grade 2
    description
    ECOG performance status was used to assess participants disease progression, and ability to carry out daily living activities. 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed less than (\<)50 percent (%) of the time; 3= In bed \>50% of the time; 4=100% bedridden; 5=Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          85
        title
        North America
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          29
        title
        Europe
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had human epidermal growth factor receptor 2+ (HER2+) tumors as defined by one or more protocol required local tests.

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Preserved source evidence · Not medical advice