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NCT03734029 · BASELINE

Baseline characteristics

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] · Source last updated 2025-10-06

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
      373
    2. group Id
      BG001
      value
      184
    3. group Id
      BG002
      value
      557
    units
    Participants
groups
  1. description
    Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
    id
    BG000
    title
    Trastuzumab Deruxtecan (T-DXd)
  2. description
    Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
    id
    BG001
    title
    Physician's Choice
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          290
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          426
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          131
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.6
          value
          56.5
        2. group Id
          BG001
          spread
          11.5
          value
          56.5
        3. group Id
          BG002
          spread
          10.9
          value
          56.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          371
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          555
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          267
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          223
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          55
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline characteristics were assessed in the Full Analysis Set. The Full Analysis Set included all participants randomized into the study, including those who did not receive a dose of study treatment. Participants were analyzed according to the treatments and strata assigned at randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      373
    2. group Id
      BG001
      value
      184
    3. group Id
      BG002
      value
      557
    units
    Participants
groups
  1. description
    Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
    id
    BG000
    title
    Trastuzumab Deruxtecan (T-DXd)
  2. description
    Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
    id
    BG001
    title
    Physician's Choice
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          290
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          426
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          131
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.6
          value
          56.5
        2. group Id
          BG001
          spread
          11.5
          value
          56.5
        3. group Id
          BG002
          spread
          10.9
          value
          56.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          371
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          555
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          267
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          223
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          55
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline characteristics were assessed in the Full Analysis Set. The Full Analysis Set included all participants randomized into the study, including those who did not receive a dose of study treatment. Participants were analyzed according to the treatments and strata assigned at randomization.

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Preserved source evidence · Not medical advice