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NCT01945775 · FLOW

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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.

groups
  1. description
    Participants received talazoparib 1 milligram (mg), orally, once daily until radiographic disease progression as determined by the central independent radiology facility (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
    FG000
    title
    Talazoparib
  2. description
    Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 milligram per meter square (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 intravenous (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
    FG001
    title
    Physician's Choice Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        214
      2. group Id
        FG001
        num Subjects
        98
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        21
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        18
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        287
      2. group Id
        FG001
        num Subjects
        144
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        286
      2. group Id
        FG001
        num Subjects
        126
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        287
      2. group Id
        FG001
        num Subjects
        144
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received talazoparib 1 milligram (mg), orally, once daily until radiographic disease progression as determined by the central independent radiology facility (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
    FG000
    title
    Talazoparib
  2. description
    Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 milligram per meter square (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 intravenous (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
    FG001
    title
    Physician's Choice Treatment
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        214
      2. group Id
        FG001
        num Subjects
        98
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        21
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        18
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        287
      2. group Id
        FG001
        num Subjects
        144
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        286
      2. group Id
        FG001
        num Subjects
        126
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        287
      2. group Id
        FG001
        num Subjects
        144
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice