Skip to content

TriangleGet started

← Full study record

NCT02422615 · OUTCOME

Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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

Measure: MEAN
Unit: Score on a Scale
Interval / dispersion: Standard Deviation
Time frame: Baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months

What was measured

The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL. The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.

Analysis population: Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.

Groups in this outcome

Ribociclib + Fulvestrant

Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

Placebo + Fulvestrant

Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

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
Ribociclib + Fulvestrant	361
Placebo + Fulvestrant	169

Reported measurements

Cycle 3 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	361
Placebo + Fulvestrant	169

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.5	18.53	Not reported	Not reported	Not reported
Placebo + Fulvestrant	2.7	17.50	Not reported	Not reported	Not reported

Cycle 5 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	316
Placebo + Fulvestrant	149

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.2	19.97	Not reported	Not reported	Not reported
Placebo + Fulvestrant	3.2	18.09	Not reported	Not reported	Not reported

Cycle 7 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	300
Placebo + Fulvestrant	133

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.9	19.47	Not reported	Not reported	Not reported
Placebo + Fulvestrant	4.3	17.30	Not reported	Not reported	Not reported

Cycle 9 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	283
Placebo + Fulvestrant	133

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.1	19.36	Not reported	Not reported	Not reported
Placebo + Fulvestrant	3.3	17.61	Not reported	Not reported	Not reported

Cycle 11 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	251
Placebo + Fulvestrant	116

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.9	17.57	Not reported	Not reported	Not reported
Placebo + Fulvestrant	2.3	18.21	Not reported	Not reported	Not reported

Cycle 13 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	240
Placebo + Fulvestrant	105

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.4	18.53	Not reported	Not reported	Not reported
Placebo + Fulvestrant	1.3	19.48	Not reported	Not reported	Not reported

Cycle 15 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	218
Placebo + Fulvestrant	96

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	3.6	18.34	Not reported	Not reported	Not reported
Placebo + Fulvestrant	3.6	19.86	Not reported	Not reported	Not reported

Cycle 17 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	216
Placebo + Fulvestrant	84

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	3.9	20.31	Not reported	Not reported	Not reported
Placebo + Fulvestrant	3.4	21.61	Not reported	Not reported	Not reported

Cycle 19 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	185
Placebo + Fulvestrant	82

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	3.8	17.57	Not reported	Not reported	Not reported
Placebo + Fulvestrant	3.7	18.52	Not reported	Not reported	Not reported

Cycle 22 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	118
Placebo + Fulvestrant	46

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	6.6	20.78	Not reported	Not reported	Not reported
Placebo + Fulvestrant	4.7	17.00	Not reported	Not reported	Not reported

Cycle 25 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	54
Placebo + Fulvestrant	19

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	5.7	16.81	Not reported	Not reported	Not reported
Placebo + Fulvestrant	8.3	18.22	Not reported	Not reported	Not reported

Cycle 28 Day 1 (Cycle= 28 days)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	12
Placebo + Fulvestrant	3

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	12.5	16.48	Not reported	Not reported	Not reported
Placebo + Fulvestrant	19.4	12.73	Not reported	Not reported	Not reported

End of treatment (EOT)

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	184
Placebo + Fulvestrant	113

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	-5.2	25.84	Not reported	Not reported	Not reported
Placebo + Fulvestrant	-5.5	24.54	Not reported	Not reported	Not reported

Post EOT1

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	11
Placebo + Fulvestrant	2

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	4.5	21.20	Not reported	Not reported	Not reported
Placebo + Fulvestrant	-33.3	23.57	Not reported	Not reported	Not reported

Post EOT2

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	7
Placebo + Fulvestrant	2

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	-4.8	19.75	Not reported	Not reported	Not reported
Placebo + Fulvestrant	-16.7	23.57	Not reported	Not reported	Not reported

Post EOT3

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	4
Placebo + Fulvestrant	2

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	14.6	24.88	Not reported	Not reported	Not reported
Placebo + Fulvestrant	-16.7	0.00	Not reported	Not reported	Not reported

Post EOT4

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	5
Placebo + Fulvestrant	1

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	10.0	20.75	Not reported	Not reported	Not reported
Placebo + Fulvestrant	-25.0	Not reported	Not reported	Not reported	Not reported

Post EOT5

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	3
Placebo + Fulvestrant	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	13.9	20.97	Not reported	Not reported	Not reported

Post EOT6

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	3
Placebo + Fulvestrant	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	22.2	12.73	Not reported	Not reported	Not reported

Post EOT7

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	3
Placebo + Fulvestrant	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	19.4	20.97	Not reported	Not reported	Not reported

Post EOT8

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	2
Placebo + Fulvestrant	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	37.5	17.68	Not reported	Not reported	Not reported

Post EOT9

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	3
Placebo + Fulvestrant	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	8.3	46.40	Not reported	Not reported	Not reported

Post EOT10

Analysis denominator · Participants

Group	Source count
Ribociclib + Fulvestrant	1
Placebo + Fulvestrant	0

Values in Score on a Scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ribociclib + Fulvestrant	-8.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
18.53
value
4.5
group Id
OG001
spread
17.50
value
2.7
denoms
counts
group Id
OG000
value
361
group Id
OG001
value
169
units
Participants
title
Cycle 3 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
19.97
value
4.2
group Id
OG001
spread
18.09
value
3.2
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
149
units
Participants
title
Cycle 5 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
19.47
value
4.9
group Id
OG001
spread
17.30
value
4.3
denoms
counts
group Id
OG000
value
300
group Id
OG001
value
133
units
Participants
title
Cycle 7 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
19.36
value
4.1
group Id
OG001
spread
17.61
value
3.3
denoms
counts
group Id
OG000
value
283
group Id
OG001
value
133
units
Participants
title
Cycle 9 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
17.57
value
4.9
group Id
OG001
spread
18.21
value
2.3
denoms
counts
group Id
OG000
value
251
group Id
OG001
value
116
units
Participants
title
Cycle 11 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
18.53
value
4.4
group Id
OG001
spread
19.48
value
1.3
denoms
counts
group Id
OG000
value
240
group Id
OG001
value
105
units
Participants
title
Cycle 13 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
18.34
value
3.6
group Id
OG001
spread
19.86
value
3.6
denoms
counts
group Id
OG000
value
218
group Id
OG001
value
96
units
Participants
title
Cycle 15 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
20.31
value
3.9
group Id
OG001
spread
21.61
value
3.4
denoms
counts
group Id
OG000
value
216
group Id
OG001
value
84
units
Participants
title
Cycle 17 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
17.57
value
3.8
group Id
OG001
spread
18.52
value
3.7
denoms
counts
group Id
OG000
value
185
group Id
OG001
value
82
units
Participants
title
Cycle 19 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
20.78
value
6.6
group Id
OG001
spread
17.00
value
4.7
denoms
counts
group Id
OG000
value
118
group Id
OG001
value
46
units
Participants
title
Cycle 22 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
16.81
value
5.7
group Id
OG001
spread
18.22
value
8.3
denoms
counts
group Id
OG000
value
54
group Id
OG001
value
19
units
Participants
title
Cycle 25 Day 1 (Cycle= 28 days)
categories
measurements
group Id
OG000
spread
16.48
value
12.5
group Id
OG001
spread
12.73
value
19.4
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
3
units
Participants
title
Cycle 28 Day 1 (Cycle= 28 days)

denoms

counts
group Id
OG000
value
361
group Id
OG001
value
169
units
Participants

description

The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, a GHS/QoL scale, and 6 single items. GHS/QoL scale scores range between 0 and 100. A high score for GHS/QoL represents better functioning or QoL. The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.

dispersion Type

Standard Deviation

groups

description
Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
id
OG000
title
Ribociclib + Fulvestrant
description
Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
id
OG001
title
Placebo + Fulvestrant

param Type

MEAN

population Description

Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.

reporting Status

POSTED

time Frame

Baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months

title

Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30

type

SECONDARY

unit Of Measure

Score on a Scale

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

Preserved source evidence · Not medical advice