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NCT03498716 · OUTCOME

Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])

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
MEAN
Unit
score on scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles

What was measured

The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.

Analysis population: PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. 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

Chemotherapy

Participants were administered paclitaxel, 80 mg/m\^2, IV infusion 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 Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.

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
Chemotherapy1083
Atezolizumab and Chemotherapy1089

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Chemotherapy1083
Atezolizumab and Chemotherapy1089
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy89.8612.14Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy89.9211.57Not reportedNot reportedNot reported
CFB: Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy1025
Atezolizumab and Chemotherapy1042
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-8.9314.97Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-8.6914.91Not reportedNot reportedNot reported
CFB: Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy938
Atezolizumab and Chemotherapy925
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-13.3018.63Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-13.5518.47Not reportedNot reportedNot reported
CFB: Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy901
Atezolizumab and Chemotherapy882
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-5.3313.79Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-6.4214.41Not reportedNot reportedNot reported
CFB: Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy898
Atezolizumab and Chemotherapy852
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-3.7113.28Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-4.4213.15Not reportedNot reportedNot reported
CFB: Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy871
Atezolizumab and Chemotherapy807
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-2.4112.87Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-3.4212.95Not reportedNot reportedNot reported
CFB: Cycle 14 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy829
Atezolizumab and Chemotherapy736
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.4112.87Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-1.9212.11Not reportedNot reportedNot reported
CFB: Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy627
Atezolizumab and Chemotherapy489
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.6512.78Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-1.8212.12Not reportedNot reportedNot reported
CFB:Study Drug Completion/Early Discontinuation

Analysis denominator · Participants

GroupSource count
Chemotherapy895
Atezolizumab and Chemotherapy965
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-2.5613.72Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-4.6816.69Not reportedNot reportedNot reported
CFB:Follow-up Month 3

Analysis denominator · Participants

GroupSource count
Chemotherapy844
Atezolizumab and Chemotherapy871
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.6212.71Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-2.2913.47Not reportedNot reportedNot reported
CFB: Follow-up Month 6

Analysis denominator · Participants

GroupSource count
Chemotherapy815
Atezolizumab and Chemotherapy818
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.7013.46Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-1.9613.78Not reportedNot reportedNot reported
CFB: Follow-up Month 9

Analysis denominator · Participants

GroupSource count
Chemotherapy757
Atezolizumab and Chemotherapy741
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.5513.75Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-1.3313.91Not reportedNot reportedNot reported
CFB: Follow-up Month 12

Analysis denominator · Participants

GroupSource count
Chemotherapy676
Atezolizumab and Chemotherapy697
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.7013.85Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-1.3713.39Not reportedNot reportedNot reported
CFB: Follow-up Month 18

Analysis denominator · Participants

GroupSource count
Chemotherapy527
Atezolizumab and Chemotherapy548
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.9213.60Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-0.9113.79Not reportedNot reportedNot reported
CFB: Follow-up Month 24

Analysis denominator · Participants

GroupSource count
Chemotherapy374
Atezolizumab and Chemotherapy392
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.3713.89Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-0.7212.91Not reportedNot reportedNot reported
CFB: Follow-up Month 30

Analysis denominator · Participants

GroupSource count
Chemotherapy223
Atezolizumab and Chemotherapy249
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-1.6115.61Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy-0.7412.72Not reportedNot reportedNot reported
CFB: Follow-up Month 36

Analysis denominator · Participants

GroupSource count
Chemotherapy119
Atezolizumab and Chemotherapy130
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-0.4214.40Not reportedNot reportedNot reported
Atezolizumab and Chemotherapy0.8213.18Not reportedNot reportedNot reported
CFB: Follow-up Month 48

Analysis denominator · Participants

GroupSource count
Chemotherapy1
Atezolizumab and Chemotherapy5
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy-13.33NANot reportedNot reportedThe standard deviation was not estimable for one participant.
Atezolizumab and Chemotherapy-2.673.65Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.14
        value
        89.86
      2. group Id
        OG001
        spread
        11.57
        value
        89.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        1083
      2. group Id
        OG001
        value
        1089
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.97
        value
        -8.93
      2. group Id
        OG001
        spread
        14.91
        value
        -8.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        1025
      2. group Id
        OG001
        value
        1042
      units
      Participants
    title
    CFB: Cycle 4 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.63
        value
        -13.30
      2. group Id
        OG001
        spread
        18.47
        value
        -13.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        938
      2. group Id
        OG001
        value
        925
      units
      Participants
    title
    CFB: Cycle 6 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.79
        value
        -5.33
      2. group Id
        OG001
        spread
        14.41
        value
        -6.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        901
      2. group Id
        OG001
        value
        882
      units
      Participants
    title
    CFB: Cycle 8 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.28
        value
        -3.71
      2. group Id
        OG001
        spread
        13.15
        value
        -4.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        898
      2. group Id
        OG001
        value
        852
      units
      Participants
    title
    CFB: Cycle 10 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.87
        value
        -2.41
      2. group Id
        OG001
        spread
        12.95
        value
        -3.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        871
      2. group Id
        OG001
        value
        807
      units
      Participants
    title
    CFB: Cycle 12 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.87
        value
        -1.41
      2. group Id
        OG001
        spread
        12.11
        value
        -1.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        829
      2. group Id
        OG001
        value
        736
      units
      Participants
    title
    CFB: Cycle 14 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.78
        value
        -1.65
      2. group Id
        OG001
        spread
        12.12
        value
        -1.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        627
      2. group Id
        OG001
        value
        489
      units
      Participants
    title
    CFB: Cycle 16 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.72
        value
        -2.56
      2. group Id
        OG001
        spread
        16.69
        value
        -4.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        895
      2. group Id
        OG001
        value
        965
      units
      Participants
    title
    CFB:Study Drug Completion/Early Discontinuation
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.71
        value
        -1.62
      2. group Id
        OG001
        spread
        13.47
        value
        -2.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        844
      2. group Id
        OG001
        value
        871
      units
      Participants
    title
    CFB:Follow-up Month 3
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.46
        value
        -1.70
      2. group Id
        OG001
        spread
        13.78
        value
        -1.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        815
      2. group Id
        OG001
        value
        818
      units
      Participants
    title
    CFB: Follow-up Month 6
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.75
        value
        -1.55
      2. group Id
        OG001
        spread
        13.91
        value
        -1.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        757
      2. group Id
        OG001
        value
        741
      units
      Participants
    title
    CFB: Follow-up Month 9
denoms
  1. counts
    1. group Id
      OG000
      value
      1083
    2. group Id
      OG001
      value
      1089
    units
    Participants
description
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were administered paclitaxel, 80 mg/m\^2, IV infusion 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 Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.
    id
    OG000
    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 Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    OG001
    title
    Atezolizumab and Chemotherapy
param Type
MEAN
population Description
PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. 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
Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
title
Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])
type
SECONDARY
unit Of Measure
score on scale

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

Preserved source evidence · Not medical advice