NCT01358877 · OUTCOME

Percentage of Participants Who Died, First Interim Overall Survival 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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

What was measured

Percentage of participants who died due to any cause is reported.

Analysis population: ITT population

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	2400
Placebo + Trastuzumab + Chemotherapy	2404

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pertuzumab + Trastuzumab + Chemotherapy	3.3	Not reported	Not reported	Not reported	Not reported
Placebo + Trastuzumab + Chemotherapy	3.7	Not reported	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
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.21
estimate Comment
Hazard ratio was estimated by Cox regression.
group Description
Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.4673
p Value Comment
The O'Brien-Fleming stopping boundary of the Lan-DeMets alpha-spending function for the first interim OS analysis was HR\<0.52; p\<0.00001.
param Type
Hazard Ratio (HR)
param Value
0.89
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.21
estimate Comment
Hazard ratio was estimated by Cox regression.
group Description
Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.4673
p Value Comment
The O'Brien-Fleming stopping boundary of the Lan-DeMets alpha-spending function for the first interim OS analysis was HR\<0.52; p\<0.00001.
param Type
Hazard Ratio (HR)
param Value
0.89
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
3.3
group Id
OG001
value
3.7

denoms

counts
group Id
OG000
value
2400
group Id
OG001
value
2404
units
Participants

description

Percentage of participants who died due to any cause is reported.

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

NUMBER

population Description

ITT population

reporting Status

POSTED

time Frame

Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)

title

Percentage of Participants Who Died, First Interim Overall Survival Analysis

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice