NCT00545688 · OUTCOME

Progression Free and Disease Free Survival

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer. · Source last updated 2017-08-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: percentage of participants
Interval / dispersion: 80% Confidence Interval
Time frame: Randomization up to a maximum of 329 weeks

What was measured

DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.

Analysis population: ITT Population; Analysis was performed according to initial randomization.

Groups in this outcome

Trastuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.

Trastuzumab+Pertuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.

Trastuzumab+Pertuzumab

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.

Pertuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.

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
Trastuzumab+Docetaxel	107
Trastuzumab+Pertuzumab+Docetaxel	107
Trastuzumab+Pertuzumab	107
Pertuzumab+Docetaxel	96

Reported measurements

PFS

Values in percentage of participants · Interval/dispersion: 80% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab+Docetaxel	NA	Not reported	NA	NA	Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
Trastuzumab+Pertuzumab+Docetaxel	71.0	Not reported	71.0	76.0	Not reported
Trastuzumab+Pertuzumab	NA	Not reported	NA	NA	Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
Pertuzumab+Docetaxel	NA	Not reported	NA	NA	Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.

DFS

Values in percentage of participants · Interval/dispersion: 80% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab+Docetaxel	NA	Not reported	NA	NA	Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
Trastuzumab+Pertuzumab+Docetaxel	67.2	Not reported	67.0	72.0	Not reported
Trastuzumab+Pertuzumab	NA	Not reported	NA	NA	Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
Pertuzumab+Docetaxel	NA	Not reported	NA	NA	Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.

Source statistical analyses

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

ci Lower Limit
0.34
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.40
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
PFS
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2983
param Type
Hazard Ratio (HR)
param Value
0.69
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.30
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
PFS
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.4722
param Type
Hazard Ratio (HR)
param Value
1.25
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
1.07
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.93
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
PFS
group Ids
OG001
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0268
param Type
Hazard Ratio (HR)
param Value
2.05
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.28
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.27
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
DFS
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1805
param Type
Hazard Ratio (HR)
param Value
0.60
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.64
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
DFS
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.5901
param Type
Hazard Ratio (HR)
param Value
0.83
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
1.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.32
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
DFS
group Ids
OG001
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0250
param Type
Hazard Ratio (HR)
param Value
2.16
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
0.34
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.40
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
PFS
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2983
param Type
Hazard Ratio (HR)
param Value
0.69
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.68
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.30
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
PFS
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.4722
param Type
Hazard Ratio (HR)
param Value
1.25
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
1.07
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.93
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
PFS
group Ids
OG001
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0268
param Type
Hazard Ratio (HR)
param Value
2.05
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.28
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.27
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
DFS
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1805
param Type
Hazard Ratio (HR)
param Value
0.60
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.64
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
DFS
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.5901
param Type
Hazard Ratio (HR)
param Value
0.83
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
1.08
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.32
estimate Comment
HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.
group Description
DFS
group Ids
OG001
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0250
param Type
Hazard Ratio (HR)
param Value
2.16
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
comment
Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
71.0
upper Limit
76.0
value
71.0
comment
Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
PFS
categories
measurements
comment
Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
67.0
upper Limit
72.0
value
67.2
comment
Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
NA
comment
Median and corresponding 80% confidence interval were not achieved due to o the low number of events in this participant population, as expected.
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
title
DFS

denoms

counts
group Id
OG000
value
107
group Id
OG001
value
107
group Id
OG002
value
107
group Id
OG003
value
96
units
Participants

description

dispersion Type

80% Confidence Interval

groups

description
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
id
OG000
title
Trastuzumab+Docetaxel
description
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
id
OG001
title
Trastuzumab+Pertuzumab+Docetaxel
description
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
id
OG002
title
Trastuzumab+Pertuzumab
description
Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
id
OG003
title
Pertuzumab+Docetaxel

param Type

MEDIAN

population Description

ITT Population; Analysis was performed according to initial randomization.

reporting Status

POSTED

time Frame

Randomization up to a maximum of 329 weeks

title

Progression Free and Disease Free Survival

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice