NCT01358877 · OUTCOME

Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis

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: percentage of blood pumped out
Interval / dispersion: Standard Deviation
Time frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)

What was measured

LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.

Analysis population: Safety population. The overall number of participants analyzed is the number of participants evaluable for this outcome measure. Number analyzed is the number of 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	2363
Placebo + Trastuzumab + Chemotherapy	2401

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Pertuzumab + Trastuzumab + Chemotherapy	2363
Placebo + Trastuzumab + Chemotherapy	2401

Values in percentage of blood pumped out · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pertuzumab + Trastuzumab + Chemotherapy	65.2	5.9	Not reported	Not reported	Not reported
Placebo + Trastuzumab + Chemotherapy	65.3	6.1	Not reported	Not reported	Not reported

Change to Worst Value

Analysis denominator · Participants

Group	Source count
Pertuzumab + Trastuzumab + Chemotherapy	2348
Placebo + Trastuzumab + Chemotherapy	2351

Values in percentage of blood pumped out · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pertuzumab + Trastuzumab + Chemotherapy	-7.5	6.6	Not reported	Not reported	Not reported
Placebo + Trastuzumab + Chemotherapy	-7.6	6.7	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-0.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.5
estimate Comment
95% CI was estimated using Hauck-Anderson correction.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Treatment Difference
param Value
0.1

Complete source fields

analyses

ci Lower Limit
-0.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.5
estimate Comment
95% CI was estimated using Hauck-Anderson correction.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Treatment Difference
param Value
0.1

classes

categories
measurements
group Id
OG000
spread
5.9
value
65.2
group Id
OG001
spread
6.1
value
65.3
denoms
counts
group Id
OG000
value
2363
group Id
OG001
value
2401
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
6.6
value
-7.5
group Id
OG001
spread
6.7
value
-7.6
denoms
counts
group Id
OG000
value
2348
group Id
OG001
value
2351
units
Participants
title
Change to Worst Value

denoms

counts
group Id
OG000
value
2363
group Id
OG001
value
2401
units
Participants

description

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

Safety population. The overall number of participants analyzed is the number of participants evaluable for this outcome measure. Number analyzed is the number of participants evaluable for this outcome measure at specified timepoint.

reporting Status

POSTED

time Frame

Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)

title

Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis

type

SECONDARY

unit Of Measure

percentage of blood pumped out

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Preserved source evidence · Not medical advice