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NCT05132582 · BASELINE

Baseline characteristics

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer · Source last updated 2026-09-29

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
      326
    2. group Id
      BG001
      value
      328
    3. group Id
      BG002
      value
      654
    units
    Participants
groups
  1. description
    Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
    id
    BG000
    title
    Tucatinib + Trastuzumab + Pertuzumab
  2. description
    Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
    id
    BG001
    title
    Placebo + Trastuzumab + Pertuzumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.5
          value
          53.2
        2. group Id
          BG001
          spread
          11.0
          value
          53.2
        3. group Id
          BG002
          spread
          11.3
          value
          53.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          326
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          654
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          294
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          230
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          79
        title
        Not reportable
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        title
        Unknown
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Multiple
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
    description
    Race is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          221
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          433
        title
        Not Hispanic, Latino/a, or of Spanish Origin
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          126
        title
        Hispanic, Latino/a, or of Spanish Origin
      3. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          80
        title
        Not reportable
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        title
        Unknown
    description
    Ethnicity is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      326
    2. group Id
      BG001
      value
      328
    3. group Id
      BG002
      value
      654
    units
    Participants
groups
  1. description
    Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
    id
    BG000
    title
    Tucatinib + Trastuzumab + Pertuzumab
  2. description
    Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
    id
    BG001
    title
    Placebo + Trastuzumab + Pertuzumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.5
          value
          53.2
        2. group Id
          BG001
          spread
          11.0
          value
          53.2
        3. group Id
          BG002
          spread
          11.3
          value
          53.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          326
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          654
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          294
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          230
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          79
        title
        Not reportable
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          13
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        title
        Unknown
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Multiple
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
    description
    Race is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          221
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          433
        title
        Not Hispanic, Latino/a, or of Spanish Origin
      2. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          126
        title
        Hispanic, Latino/a, or of Spanish Origin
      3. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          80
        title
        Not reportable
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        title
        Unknown
    description
    Ethnicity is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice