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NCT01772472 · BASELINE

Baseline characteristics

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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
      743
    2. group Id
      BG001
      value
      743
    3. group Id
      BG002
      value
      1486
    units
    Participants
groups
  1. description
    Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    BG000
    title
    Trastuzumab
  2. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    BG001
    title
    Trastuzumab Emtansine
  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
          675
        2. group Id
          BG001
          value
          685
        3. group Id
          BG002
          value
          1360
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          126
        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
          value
          740
        2. group Id
          BG001
          value
          741
        3. group Id
          BG002
          value
          1481
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        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
          107
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          198
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          543
        2. group Id
          BG001
          value
          579
        3. group Id
          BG002
          value
          1122
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          166
        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
          50
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          86
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          129
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          40
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          530
        2. group Id
          BG001
          value
          551
        3. group Id
          BG002
          value
          1081
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          146
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants who were randomized to the study regardless of whether they received any study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      743
    2. group Id
      BG001
      value
      743
    3. group Id
      BG002
      value
      1486
    units
    Participants
groups
  1. description
    Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    BG000
    title
    Trastuzumab
  2. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    BG001
    title
    Trastuzumab Emtansine
  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
          675
        2. group Id
          BG001
          value
          685
        3. group Id
          BG002
          value
          1360
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          126
        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
          value
          740
        2. group Id
          BG001
          value
          741
        3. group Id
          BG002
          value
          1481
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        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
          107
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          198
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          543
        2. group Id
          BG001
          value
          579
        3. group Id
          BG002
          value
          1122
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          166
        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
          50
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          86
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          129
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          40
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          530
        2. group Id
          BG001
          value
          551
        3. group Id
          BG002
          value
          1081
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          146
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all participants who were randomized to the study regardless of whether they received any study treatment.

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

Preserved source evidence · Not medical advice