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NCT01358877 · OUTCOME

Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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

Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.

Analysis population: The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event 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 + Chemotherapy1491
Placebo + Trastuzumab + Chemotherapy1434
Values in Estimate of percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy92.49Not reported91.4093.59Not reported
Placebo + Trastuzumab + Chemotherapy89.91Not reported88.6691.16Not reported
8 Years

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy1773
Placebo + Trastuzumab + Chemotherapy1741
Values in Estimate of percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy92.11Not reported90.9993.23Not reported
Placebo + Trastuzumab + Chemotherapy88.88Not reported87.5990.18Not reported
10 Years

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy1752
Placebo + Trastuzumab + Chemotherapy1655
Values in Estimate of percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy91.87Not reported90.7493.00Not reported
Placebo + Trastuzumab + Chemotherapy88.10Not reported86.7689.44Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.40
        upper Limit
        93.59
        value
        92.49
      2. group Id
        OG001
        lower Limit
        88.66
        upper Limit
        91.16
        value
        89.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        1491
      2. group Id
        OG001
        value
        1434
      units
      Participants
    title
    6 Years
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.99
        upper Limit
        93.23
        value
        92.11
      2. group Id
        OG001
        lower Limit
        87.59
        upper Limit
        90.18
        value
        88.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        1773
      2. group Id
        OG001
        value
        1741
      units
      Participants
    title
    8 Years
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.74
        upper Limit
        93.00
        value
        91.87
      2. group Id
        OG001
        lower Limit
        86.76
        upper Limit
        89.44
        value
        88.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        1752
      2. group Id
        OG001
        value
        1655
      units
      Participants
    title
    10 Years
denoms
  1. counts
    1. group Id
      OG000
      value
      2400
    2. group Id
      OG001
      value
      2404
    units
    Participants
description
Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.
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 an event 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 RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
type
SECONDARY
unit Of Measure
Estimate of percentage of participants

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Preserved source evidence · Not medical advice