NCT00976989 · OUTCOME

Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures

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: MEAN
Unit: percentage (ejection fraction)
Interval / dispersion: Standard Deviation
Time frame: From baseline up to approximately 3.5 years

What was measured

Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.

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

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	71
T+P Sequential Anthracycline-based Chemotherapy	72
T+P Concomitant Non-Anthracycline Chemotherapy	73

Reported measurements

Source class 1

Values in percentage (ejection fraction) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
T+P Concomitant Anthracycline-based Chemotherapy	-6.6	5.15	Not reported	Not reported	Not reported
T+P Sequential Anthracycline-based Chemotherapy	-8.4	5.66	Not reported	Not reported	Not reported
T+P Concomitant Non-Anthracycline Chemotherapy	-7.0	6.48	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5.15
value
-6.6
group Id
OG001
spread
5.66
value
-8.4
group Id
OG002
spread
6.48
value
-7.0

denoms

counts
group Id
OG000
value
71
group Id
OG001
value
72
group Id
OG002
value
73
units
Participants

description

Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.

dispersion Type

Standard Deviation

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

MEAN

population Description

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

reporting Status

POSTED

time Frame

From baseline up to approximately 3.5 years

title

Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures

type

SECONDARY

unit Of Measure

percentage (ejection fraction)

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

Preserved source evidence · Not medical advice