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NCT03901339 · BASELINE

Baseline characteristics

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer · Source last updated 2024-10-21

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
      272
    2. group Id
      BG001
      value
      271
    3. group Id
      BG002
      value
      543
    units
    Participants
groups
  1. description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
    id
    BG000
    title
    Sacituzumab Govitecan
  2. description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    BG001
    title
    Treatment of Physician's Choice (TPC)
  3. id
    BG002
    title
    Total~(N=543)
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
          199
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          403
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          140
        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
          11.5
          value
          57
        2. group Id
          BG001
          spread
          10.4
          value
          56
        3. group Id
          BG002
          spread
          11.0
          value
          56
    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
          270
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          538
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        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
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          222
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          426
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          99
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          362
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
        title
        Unknown or Not Reported
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          21
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Other or More Than One Race
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          228
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          137
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          69
      title
      Spain
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          46
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          25
      title
      Belgium
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      United Kingdom
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Netherlands
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Canada
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) Population included all participants who were randomized, regardless of whether they received study treatment or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      272
    2. group Id
      BG001
      value
      271
    3. group Id
      BG002
      value
      543
    units
    Participants
groups
  1. description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).
    id
    BG000
    title
    Sacituzumab Govitecan
  2. description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    BG001
    title
    Treatment of Physician's Choice (TPC)
  3. id
    BG002
    title
    Total~(N=543)
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
          199
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          403
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          140
        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
          11.5
          value
          57
        2. group Id
          BG001
          spread
          10.4
          value
          56
        3. group Id
          BG002
          spread
          11.0
          value
          56
    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
          270
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          538
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        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
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          222
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          426
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          99
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          362
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          139
        title
        Unknown or Not Reported
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          21
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Other or More Than One Race
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          228
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          137
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          69
      title
      Spain
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          46
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          25
      title
      Belgium
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      United Kingdom
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
      title
      Netherlands
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Canada
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) Population included all participants who were randomized, regardless of whether they received study treatment or not.

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