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NCT04494425 · BASELINE

Baseline characteristics

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer · Source last updated 2026-03-04

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
      436
    2. group Id
      BG001
      value
      430
    3. group Id
      BG002
      value
      866
    units
    Participants
groups
  1. description
    Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    BG000
    title
    T-DXd
  2. description
    Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.46
          value
          58.2
        2. group Id
          BG001
          spread
          10.92
          value
          58.2
        3. group Id
          BG002
          spread
          11.19
          value
          58.2
    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
          436
        2. group Id
          BG001
          value
          429
        3. group Id
          BG002
          value
          865
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      3. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          305
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          231
        2. group Id
          BG001
          value
          230
        3. group Id
          BG002
          value
          461
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          19
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          73
        title
        Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          60
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          397
        2. group Id
          BG001
          value
          387
        3. group Id
          BG002
          value
          784
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Intent-to-treat (ITT) population included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      436
    2. group Id
      BG001
      value
      430
    3. group Id
      BG002
      value
      866
    units
    Participants
groups
  1. description
    Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    BG000
    title
    T-DXd
  2. description
    Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.46
          value
          58.2
        2. group Id
          BG001
          spread
          10.92
          value
          58.2
        3. group Id
          BG002
          spread
          11.19
          value
          58.2
    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
          436
        2. group Id
          BG001
          value
          429
        3. group Id
          BG002
          value
          865
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      3. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          305
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          231
        2. group Id
          BG001
          value
          230
        3. group Id
          BG002
          value
          461
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          19
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          73
        title
        Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          60
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          397
        2. group Id
          BG001
          value
          387
        3. group Id
          BG002
          value
          784
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Intent-to-treat (ITT) population included all randomized participants.

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

Preserved source evidence · Not medical advice