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NCT03125902 · FLOW

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A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Placebo + Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    FG001
    title
    Atezolizumab + Paclitaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        229
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        13
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        143
      type
      Study Terminated By Sponsor
    8. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        37
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        431
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        431
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.
Complete source fields
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Placebo + Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    FG001
    title
    Atezolizumab + Paclitaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        119
      2. group Id
        FG001
        num Subjects
        229
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        13
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        143
      type
      Study Terminated By Sponsor
    8. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        37
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        431
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        431
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.

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