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NCT02445391 · BASELINE

Baseline characteristics

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy · Source last updated 2026-07-27

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
      148
    2. group Id
      BG001
      value
      160
    3. group Id
      BG002
      value
      308
    units
    Participants
groups
  1. description
    Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
    id
    BG000
    title
    Arm B (Cisplatin or Carboplatin)
  2. description
    Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
    id
    BG001
    title
    Arm C (Capecitabine) (Open to Accrual 6/22/2016)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          72
          value
          52
        2. group Id
          BG001
          lower Limit
          26
          upper Limit
          76
          value
          52
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          76
          value
          52
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          160
        3. group Id
          BG002
          value
          308
        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. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          259
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          59
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          219
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All patients who were concurrently randomized to arms B and C after 6/22/2016 and had basal-subtype disease, this was the primary analysis population for IDFS and other secondary efficacy endpoints (OS and RFS). Only patients included in the primary analysis are included in the analysis of baseline characteristics.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      148
    2. group Id
      BG001
      value
      160
    3. group Id
      BG002
      value
      308
    units
    Participants
groups
  1. description
    Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
    id
    BG000
    title
    Arm B (Cisplatin or Carboplatin)
  2. description
    Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
    id
    BG001
    title
    Arm C (Capecitabine) (Open to Accrual 6/22/2016)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          72
          value
          52
        2. group Id
          BG001
          lower Limit
          26
          upper Limit
          76
          value
          52
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          76
          value
          52
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          160
        3. group Id
          BG002
          value
          308
        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. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          259
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          16
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          59
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          219
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All patients who were concurrently randomized to arms B and C after 6/22/2016 and had basal-subtype disease, this was the primary analysis population for IDFS and other secondary efficacy endpoints (OS and RFS). Only patients included in the primary analysis are included in the analysis of baseline characteristics.

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Preserved source evidence · Not medical advice