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NCT01358877 · OUTCOME

Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer · Source last updated 2025-11-28

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

Measure
NUMBER
Unit
Estimate of percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
6, 8, and 10 years

What was measured

The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.

Analysis population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for death at at the time of analysis for each timepoint.

Groups in this outcome

Pertuzumab + Trastuzumab + Chemotherapy

Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).

Placebo + Trastuzumab + Chemotherapy

Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).

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 + Chemotherapy2400
Placebo + Trastuzumab + Chemotherapy2404

Reported measurements

6 Years

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy1544
Placebo + Trastuzumab + Chemotherapy1522
Values in Estimate of percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy94.78Not reported93.8595.71Not reported
Placebo + Trastuzumab + Chemotherapy93.93Not reported92.9394.92Not reported
8 Years

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy1827
Placebo + Trastuzumab + Chemotherapy1834
Values in Estimate of percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy92.74Not reported91.6693.82Not reported
Placebo + Trastuzumab + Chemotherapy91.96Not reported90.8393.09Not reported
10 Years

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy1798
Placebo + Trastuzumab + Chemotherapy1742
Values in Estimate of percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy91.55Not reported90.3892.71Not reported
Placebo + Trastuzumab + Chemotherapy89.79Not reported88.5391.06Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        93.85
        upper Limit
        95.71
        value
        94.78
      2. group Id
        OG001
        lower Limit
        92.93
        upper Limit
        94.92
        value
        93.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        1544
      2. group Id
        OG001
        value
        1522
      units
      Participants
    title
    6 Years
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.66
        upper Limit
        93.82
        value
        92.74
      2. group Id
        OG001
        lower Limit
        90.83
        upper Limit
        93.09
        value
        91.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        1827
      2. group Id
        OG001
        value
        1834
      units
      Participants
    title
    8 Years
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.38
        upper Limit
        92.71
        value
        91.55
      2. group Id
        OG001
        lower Limit
        88.53
        upper Limit
        91.06
        value
        89.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        1798
      2. group Id
        OG001
        value
        1742
      units
      Participants
    title
    10 Years
denoms
  1. counts
    1. group Id
      OG000
      value
      2400
    2. group Id
      OG001
      value
      2404
    units
    Participants
description
The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    id
    OG000
    title
    Pertuzumab + Trastuzumab + Chemotherapy
  2. description
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    id
    OG001
    title
    Placebo + Trastuzumab + Chemotherapy
param Type
NUMBER
population Description
The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for death at at the time of analysis for each timepoint.
reporting Status
POSTED
time Frame
6, 8, and 10 years
title
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years
type
SECONDARY
unit Of Measure
Estimate of percentage of participants

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