NCT00976989 · OUTCOME

Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator

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 up to approximately 3.5 years

What was measured

Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.

Analysis population: Safety population included all participants who were randomized and received study drug.

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

Source class 1

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	2.7	Not reported	Not reported	Not reported	Not reported
T+P Concomitant Non-Anthracycline Chemotherapy	1.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2.7
group Id
OG002
value
1.3

denoms

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

description

Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic 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 population included all participants who were randomized and received study drug.

reporting Status

POSTED

time Frame

From baseline up to approximately 3.5 years

title

Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice