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NCT01358877 · OUTCOME

Cmin of Trastuzumab

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
MEAN
Unit
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Cycles 1, 10 and 15 (Cycle length=21 days)

Analysis population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified 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 + Chemotherapy36
Placebo + Trastuzumab + Chemotherapy34

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy32
Placebo + Trastuzumab + Chemotherapy31
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy32.113.4Not reportedNot reportedNot reported
Placebo + Trastuzumab + Chemotherapy34.111.4Not reportedNot reportedNot reported
Cycle 10

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy33
Placebo + Trastuzumab + Chemotherapy26
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy65.039.6Not reportedNot reportedNot reported
Placebo + Trastuzumab + Chemotherapy68.423.0Not reportedNot reportedNot reported
Cycle 15

Analysis denominator · Participants

GroupSource count
Pertuzumab + Trastuzumab + Chemotherapy27
Placebo + Trastuzumab + Chemotherapy22
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pertuzumab + Trastuzumab + Chemotherapy72.946.1Not reportedNot reportedNot reported
Placebo + Trastuzumab + Chemotherapy71.030.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.4
        value
        32.1
      2. group Id
        OG001
        spread
        11.4
        value
        34.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.6
        value
        65.0
      2. group Id
        OG001
        spread
        23.0
        value
        68.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    Cycle 10
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.1
        value
        72.9
      2. group Id
        OG001
        spread
        30.4
        value
        71.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Cycle 15
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      34
    units
    Participants
dispersion Type
Standard Deviation
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
MEAN
population Description
PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
reporting Status
POSTED
time Frame
Cycles 1, 10 and 15 (Cycle length=21 days)
title
Cmin of Trastuzumab
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice