NCT00976989 · OUTCOME

Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer · Source last updated 2017-02-06

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: From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)

What was measured

Percentage of participants with signs or symptoms of cardiac events.

Analysis population: Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.

Groups in this outcome

T+P Concomitant Anthracycline-based Chemotherapy

5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

T+P Sequential Anthracycline-based Chemotherapy

FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.

T+P Concomitant Non-Anthracycline Chemotherapy

Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

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
T+P Concomitant Anthracycline-based Chemotherapy	72
T+P Sequential Anthracycline-based Chemotherapy	75
T+P Concomitant Non-Anthracycline Chemotherapy	76

Reported measurements

Neoadjuvant Period (n=72, 75, 76)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
T+P Concomitant Anthracycline-based Chemotherapy	1.4	Not reported	Not reported	Not reported	Not reported
T+P Sequential Anthracycline-based Chemotherapy	2.7	Not reported	Not reported	Not reported	Not reported
T+P Concomitant Non-Anthracycline Chemotherapy	0	Not reported	Not reported	Not reported	Not reported

Adjuvant Period (n= 68, 65, 67)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
T+P Concomitant Anthracycline-based Chemotherapy	0	Not reported	Not reported	Not reported	Not reported
T+P Sequential Anthracycline-based Chemotherapy	0	Not reported	Not reported	Not reported	Not reported
T+P Concomitant Non-Anthracycline Chemotherapy	1.5	Not reported	Not reported	Not reported	Not reported

Follow-up Period (n=70, 75, 74)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
T+P Concomitant Anthracycline-based Chemotherapy	0	Not reported	Not reported	Not reported	Not reported
T+P Sequential Anthracycline-based Chemotherapy	1.3	Not reported	Not reported	Not reported	Not reported
T+P Concomitant Non-Anthracycline Chemotherapy	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1.4
group Id
OG001
value
2.7
group Id
OG002
value
0
title
Neoadjuvant Period (n=72, 75, 76)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1.5
title
Adjuvant Period (n= 68, 65, 67)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1.3
group Id
OG002
value
0
title
Follow-up Period (n=70, 75, 74)

denoms

counts
group Id
OG000
value
72
group Id
OG001
value
75
group Id
OG002
value
76
units
Participants

description

Percentage of participants with signs or symptoms of cardiac events.

groups

description
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
id
OG000
title
T+P Concomitant Anthracycline-based Chemotherapy
description
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
id
OG001
title
T+P Sequential Anthracycline-based Chemotherapy
description
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
id
OG002
title
T+P Concomitant Non-Anthracycline Chemotherapy

param Type

NUMBER

population Description

Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.

reporting Status

POSTED

time Frame

From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)

title

Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)

type

SECONDARY

unit Of Measure

percentage of participants

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