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NCT03498716 · OUTCOME

Serum Concentration of Atezolizumab

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.

Measure
GEOMETRIC_MEAN
Unit
microgram per milliliter (µg/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles

Analysis population: Pharmacokinetic (PK)-evaluable population included all participants who received any dose of study medication and who have at least one evaluable postbaseline PK sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point.

Groups in this outcome

Atezolizumab and Chemotherapy

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 Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy952

Reported measurements

Post-dose: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy853
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy31943.3Not reportedNot reportedNot reported
Pre-dose: Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy854
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy15385.2Not reportedNot reportedNot reported
Pre-dose: Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy833
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy22062.0Not reportedNot reportedNot reported
Pre-dose: Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy819
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy221120.4Not reportedNot reportedNot reported
Pre-dose: Cycle 6

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy727
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy239146.9Not reportedNot reportedNot reported
Pre-dose: Cycle 10

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy650
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy25092.2Not reportedNot reportedNot reported
Pre-dose: Cycle 14

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy556
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy258118.7Not reportedNot reportedNot reported
Pre-dose: Cycle 16 Day 2

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy2
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy35529.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.3
        value
        319
    denoms
    1. counts
      1. group Id
        OG000
        value
        853
      units
      Participants
    title
    Post-dose: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        85.2
        value
        153
    denoms
    1. counts
      1. group Id
        OG000
        value
        854
      units
      Participants
    title
    Pre-dose: Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.0
        value
        220
    denoms
    1. counts
      1. group Id
        OG000
        value
        833
      units
      Participants
    title
    Pre-dose: Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        120.4
        value
        221
    denoms
    1. counts
      1. group Id
        OG000
        value
        819
      units
      Participants
    title
    Pre-dose: Cycle 4 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        146.9
        value
        239
    denoms
    1. counts
      1. group Id
        OG000
        value
        727
      units
      Participants
    title
    Pre-dose: Cycle 6
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        92.2
        value
        250
    denoms
    1. counts
      1. group Id
        OG000
        value
        650
      units
      Participants
    title
    Pre-dose: Cycle 10
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        118.7
        value
        258
    denoms
    1. counts
      1. group Id
        OG000
        value
        556
      units
      Participants
    title
    Pre-dose: Cycle 14
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.5
        value
        355
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Pre-dose: Cycle 16 Day 2
denoms
  1. counts
    1. group Id
      OG000
      value
      952
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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 Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    OG000
    title
    Atezolizumab and Chemotherapy
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK)-evaluable population included all participants who received any dose of study medication and who have at least one evaluable postbaseline PK sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point.
reporting Status
POSTED
time Frame
Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles
title
Serum Concentration of Atezolizumab
type
SECONDARY
unit Of Measure
microgram per milliliter (µg/mL)

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

Preserved source evidence · Not medical advice