NCT01358877 · OUTCOME

Cmax 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

Group	Source count
Pertuzumab + Trastuzumab + Chemotherapy	36
Placebo + Trastuzumab + Chemotherapy	34

Reported measurements

Cycle 1

Analysis denominator · Participants

Group	Source count
Pertuzumab + Trastuzumab + Chemotherapy	36
Placebo + Trastuzumab + Chemotherapy	33

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pertuzumab + Trastuzumab + Chemotherapy	180	81.0	Not reported	Not reported	Not reported
Placebo + Trastuzumab + Chemotherapy	190	51.6	Not reported	Not reported	Not reported

Cycle 10

Analysis denominator · Participants

Group	Source count
Pertuzumab + Trastuzumab + Chemotherapy	33
Placebo + Trastuzumab + Chemotherapy	27

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pertuzumab + Trastuzumab + Chemotherapy	219	94.6	Not reported	Not reported	Not reported
Placebo + Trastuzumab + Chemotherapy	225	70.7	Not reported	Not reported	Not reported

Cycle 15

Analysis denominator · Participants

Group	Source count
Pertuzumab + Trastuzumab + Chemotherapy	25
Placebo + Trastuzumab + Chemotherapy	21

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pertuzumab + Trastuzumab + Chemotherapy	187	95.1	Not reported	Not reported	Not reported
Placebo + Trastuzumab + Chemotherapy	234	73.5	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
81.0
value
180
group Id
OG001
spread
51.6
value
190
denoms
counts
group Id
OG000
value
36
group Id
OG001
value
33
units
Participants
title
Cycle 1
categories
measurements
group Id
OG000
spread
94.6
value
219
group Id
OG001
spread
70.7
value
225
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
27
units
Participants
title
Cycle 10
categories
measurements
group Id
OG000
spread
95.1
value
187
group Id
OG001
spread
73.5
value
234
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
21
units
Participants
title
Cycle 15

denoms

counts
group Id
OG000
value
36
group Id
OG001
value
34
units
Participants

dispersion Type

Standard Deviation

groups

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
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

Cmax of Trastuzumab

type

SECONDARY

unit Of Measure

mcg/mL

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Preserved source evidence · Not medical advice