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NCT01945775 · BASELINE

Baseline characteristics

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) · Source last updated 2022-01-20

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
      287
    2. group Id
      BG001
      value
      144
    3. group Id
      BG002
      value
      431
    units
    Participants
groups
  1. description
    Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
    id
    BG000
    title
    Talazoparib
  2. description
    Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
    id
    BG001
    title
    Physician's Choice Treatment
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.61
          value
          47.5
        2. group Id
          BG001
          spread
          12.12
          value
          49.4
        3. group Id
          BG002
          spread
          11.80
          value
          48.1
    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
          283
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          424
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          31
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          46
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          318
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          67
        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
          31
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          47
        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
          11
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          298
        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
          55
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          74
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) analysis population included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      287
    2. group Id
      BG001
      value
      144
    3. group Id
      BG002
      value
      431
    units
    Participants
groups
  1. description
    Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
    id
    BG000
    title
    Talazoparib
  2. description
    Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
    id
    BG001
    title
    Physician's Choice Treatment
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.61
          value
          47.5
        2. group Id
          BG001
          spread
          12.12
          value
          49.4
        3. group Id
          BG002
          spread
          11.80
          value
          48.1
    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
          283
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          424
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          31
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          46
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          318
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          67
        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
          31
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          47
        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
          11
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          298
        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
          55
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          74
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) analysis population included all randomized participants.

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

Preserved source evidence · Not medical advice