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NCT00567190 · OUTCOME

Objective Response Determined by an Independent Review Facility

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

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

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Tumor assessments every 9 weeks from Baseline until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)

What was measured

An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by an independent review facility (IRF) using RECIST v1.0 on two consecutive occasions ≥4 weeks apart. For target lesions, CR: disappearance of all target lesions; PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions (baseline sum LD as reference); PD: ≥20% increase in the sum of the LD of target lesions (smallest sum of the LD recorded as reference) or appearance of ≥1 new lesion; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for PD. For non-target lesions, CR: disappearance of all non-target lesions; Incomplete/SD: persistence of ≥1 non-target lesions; PD: unequivocal progression of existing non-target lesions. 95% confidence intervals (CI) were calculated only for clinical responses using the Pearson-Clopper method.

Analysis population: ITT Population: All randomized participants; only participants with IRF-determined measurable disease at baseline (i.e., ≥1 target lesion) were included in the analysis.

Groups in this outcome

Pertuzumab + Trastuzumab + Docetaxel

Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

Placebo + Trastuzumab + Docetaxel

Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

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

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Docetaxel343
Placebo + Trastuzumab + Docetaxel336

Reported measurements

Objective Response (CR + PR)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel80.2Not reported75.684.3Not reported
Placebo + Trastuzumab + Docetaxel69.3Not reported64.174.2Not reported
Complete Response (CR)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel5.5Not reported3.48.5Not reported
Placebo + Trastuzumab + Docetaxel4.2Not reported2.36.9Not reported
Partial Response (PR)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel74.6Not reported69.779.2Not reported
Placebo + Trastuzumab + Docetaxel65.2Not reported59.870.3Not reported
Stable Disease (SD)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel14.6Not reported11.018.8Not reported
Placebo + Trastuzumab + Docetaxel20.8Not reported16.625.6Not reported
Progressive Disease (PD)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel3.8Not reported2.06.4Not reported
Placebo + Trastuzumab + Docetaxel8.3Not reported5.611.8Not reported
Unable to Assess (UA)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel0.6Not reported0.12.1Not reported
Placebo + Trastuzumab + Docetaxel0.6Not reported0.12.1Not reported
Missing (No Assessment)
Values in Percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Docetaxel0.9Not reportedNANA95% confidence intervals were calculated only for clinical responses.
Placebo + Trastuzumab + Docetaxel0.9Not reportedNANA95% confidence intervals were calculated only for clinical responses.

Source statistical analyses

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

  1. ci Lower Limit
    4.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.5
    estimate Comment
    Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.
    group Description
    Difference in Objective Response (CR + PR) Between Arms
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0011
    param Type
    Difference in Objective Response Rates
    param Value
    10.83
    statistical Comment
    Stratified by prior treatment status and region.
    statistical Method
    Mantel Haenszel
  2. ci Lower Limit
    1.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.54
    group Description
    Odds Ratio for Objective Response (CR + PR)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.79
Complete source fields
analyses
  1. ci Lower Limit
    4.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.5
    estimate Comment
    Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.
    group Description
    Difference in Objective Response (CR + PR) Between Arms
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0011
    param Type
    Difference in Objective Response Rates
    param Value
    10.83
    statistical Comment
    Stratified by prior treatment status and region.
    statistical Method
    Mantel Haenszel
  2. ci Lower Limit
    1.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.54
    group Description
    Odds Ratio for Objective Response (CR + PR)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    1.79
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75.6
        upper Limit
        84.3
        value
        80.2
      2. group Id
        OG001
        lower Limit
        64.1
        upper Limit
        74.2
        value
        69.3
    title
    Objective Response (CR + PR)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.4
        upper Limit
        8.5
        value
        5.5
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        6.9
        value
        4.2
    title
    Complete Response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.7
        upper Limit
        79.2
        value
        74.6
      2. group Id
        OG001
        lower Limit
        59.8
        upper Limit
        70.3
        value
        65.2
    title
    Partial Response (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.0
        upper Limit
        18.8
        value
        14.6
      2. group Id
        OG001
        lower Limit
        16.6
        upper Limit
        25.6
        value
        20.8
    title
    Stable Disease (SD)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        6.4
        value
        3.8
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        11.8
        value
        8.3
    title
    Progressive Disease (PD)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        2.1
        value
        0.6
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        2.1
        value
        0.6
    title
    Unable to Assess (UA)
  7. categories
    1. measurements
      1. comment
        95% confidence intervals were calculated only for clinical responses.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0.9
      2. comment
        95% confidence intervals were calculated only for clinical responses.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0.9
    title
    Missing (No Assessment)
denoms
  1. counts
    1. group Id
      OG000
      value
      343
    2. group Id
      OG001
      value
      336
    units
    Participants
description
An objective response was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR) determined by an independent review facility (IRF) using RECIST v1.0 on two consecutive occasions ≥4 weeks apart. For target lesions, CR: disappearance of all target lesions; PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions (baseline sum LD as reference); PD: ≥20% increase in the sum of the LD of target lesions (smallest sum of the LD recorded as reference) or appearance of ≥1 new lesion; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for PD. For non-target lesions, CR: disappearance of all non-target lesions; Incomplete/SD: persistence of ≥1 non-target lesions; PD: unequivocal progression of existing non-target lesions. 95% confidence intervals (CI) were calculated only for clinical responses using the Pearson-Clopper method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    OG000
    title
    Pertuzumab + Trastuzumab + Docetaxel
  2. description
    Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    OG001
    title
    Placebo + Trastuzumab + Docetaxel
param Type
NUMBER
population Description
ITT Population: All randomized participants; only participants with IRF-determined measurable disease at baseline (i.e., ≥1 target lesion) were included in the analysis.
reporting Status
POSTED
time Frame
Tumor assessments every 9 weeks from Baseline until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)
title
Objective Response Determined by an Independent Review Facility
type
SECONDARY
unit Of Measure
Percentage of patients

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Preserved source evidence · Not medical advice