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NCT03498716 · OUTCOME

Invasive Disease-Free Survival (iDFS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)

What was measured

iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.

Analysis population: ITT population included all randomized participants, whether or not the assigned study treatment was received.

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
Chemotherapy1098
Atezolizumab and Chemotherapy1101

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ChemotherapyNANot reportedNANAMedian and 95% CI for iDFS were not estimable due to too few events having occurred.
Atezolizumab and ChemotherapyNANot reportedNANAMedian and 95% CI for iDFS were not estimable due to too few events having occurred.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.42
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3846
    param Type
    Hazard Ratio (HR)
    param Value
    1.11
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.42
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3846
    param Type
    Hazard Ratio (HR)
    param Value
    1.11
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% CI for iDFS were not estimable due to too few events having occurred.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median and 95% CI for iDFS were not estimable due to too few events having occurred.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1098
    2. group Id
      OG001
      value
      1101
    units
    Participants
description
iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
ITT population included all randomized participants, whether or not the assigned study treatment was received.
reporting Status
POSTED
time Frame
From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
title
Invasive Disease-Free Survival (iDFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice