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NCT03498716 · FLOW

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A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer · Source last updated 2024-08-21

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

groups
  1. description
    Participants were administered paclitaxel, 80 milligram per square meter (mg/m\^2), intravenous (IV) infusion weekly (QW) for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every 2 weeks (Q2W) for a maximum of 20 weeks supported with granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) treatment.
    id
    FG000
    title
    Chemotherapy
  2. description
    Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every 3 weeks (Q3W) as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    FG001
    title
    Atezolizumab and Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        88
      2. group Id
        FG001
        num Subjects
        73
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        933
      2. group Id
        FG001
        num Subjects
        927
      type
      Study Terminated By Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        26
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease Relapse
    5. reasons
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        72
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1098
      2. group Id
        FG001
        num Subjects
        1101
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1084
      2. group Id
        FG001
        num Subjects
        1093
      comment
      Safety Evaluable Population included all participants who received any amount of any study drug.
      type
      Safety Evaluable Population
    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
        1098
      2. group Id
        FG001
        num Subjects
        1101
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 2199 participants were enrolled in the study. Participants were randomized in a 1:1 ratio to receive Atezolizumab and Chemotherapy or Chemotherapy alone.
recruitment Details
Participants with newly diagnosed Stage II-III primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery, were enrolled in 342 centers in 31 countries.
Complete source fields
groups
  1. description
    Participants were administered paclitaxel, 80 milligram per square meter (mg/m\^2), intravenous (IV) infusion weekly (QW) for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every 2 weeks (Q2W) for a maximum of 20 weeks supported with granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) treatment.
    id
    FG000
    title
    Chemotherapy
  2. description
    Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every 3 weeks (Q3W) as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    FG001
    title
    Atezolizumab and Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        88
      2. group Id
        FG001
        num Subjects
        73
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        933
      2. group Id
        FG001
        num Subjects
        927
      type
      Study Terminated By Sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        26
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease Relapse
    5. reasons
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        72
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1098
      2. group Id
        FG001
        num Subjects
        1101
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1084
      2. group Id
        FG001
        num Subjects
        1093
      comment
      Safety Evaluable Population included all participants who received any amount of any study drug.
      type
      Safety Evaluable Population
    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
        1098
      2. group Id
        FG001
        num Subjects
        1101
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 2199 participants were enrolled in the study. Participants were randomized in a 1:1 ratio to receive Atezolizumab and Chemotherapy or Chemotherapy alone.
recruitment Details
Participants with newly diagnosed Stage II-III primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery, were enrolled in 342 centers in 31 countries.

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Preserved source evidence · Not medical advice