Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Score at Week 91
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer · Source last updated 2026-03-04
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 (Day 1) and Week 91
What was measured
EORTC QLQ-C30 is a 30-item self-administered questionnaire grouped into 5 multi-item functional scales(physical,role,emotional,cognitive and social),3 multiitem symptom scales(fatigue,pain and nausea/vomiting),2-item global QoL scale,5 single items assessing additional symptoms reported by cancer participants(dyspnea,loss of appetite,insomnia,constipation and diarrhea). All but 2 questions have 4-point scales:1:not at all,2:a little,3:quite a bit,4:very much.2 questions concerning global health status and QoL have 7-point scales with responses ranging from 1:very poor to 7:excellent;higher score:better level of functioning/greater degree of symptoms.For each of 15 scales,final scores were averaged from scores of component items,transformed,range: 0 to 100;higher scores:better functioning,better health related (HR)QoL,or greater level of symptoms(higher scores:opposite interpretations for functioning/QoL and symptoms/problems).Baseline:last observed measurement prior to randomization.
Analysis population: The ITT population included all randomized participants. Only participants with data collected in specified categories are reported.
Groups in this outcome
T-DXd
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
Chemotherapy
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
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-DXd
44
Chemotherapy
22
Reported measurements
Physical Functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-7.88
17.389
Not reported
Not reported
Not reported
Chemotherapy
-4.85
13.520
Not reported
Not reported
Not reported
Role Functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-14.77
21.631
Not reported
Not reported
Not reported
Chemotherapy
-12.12
26.318
Not reported
Not reported
Not reported
Emotional Functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-6.06
25.440
Not reported
Not reported
Not reported
Chemotherapy
1.52
22.218
Not reported
Not reported
Not reported
Cognitive Functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-8.71
22.872
Not reported
Not reported
Not reported
Chemotherapy
-6.82
19.009
Not reported
Not reported
Not reported
Social Functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-10.98
23.000
Not reported
Not reported
Not reported
Chemotherapy
-7.58
21.656
Not reported
Not reported
Not reported
Fatigue
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
11.87
24.367
Not reported
Not reported
Not reported
Chemotherapy
8.59
18.444
Not reported
Not reported
Not reported
Pain
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-1.89
21.025
Not reported
Not reported
Not reported
Chemotherapy
-0.76
24.922
Not reported
Not reported
Not reported
Nausea/Vomiting
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
9.85
19.128
Not reported
Not reported
Not reported
Chemotherapy
-0.76
12.037
Not reported
Not reported
Not reported
Global Health Status/QoL
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
-7.77
23.529
Not reported
Not reported
Not reported
Chemotherapy
-10.61
22.150
Not reported
Not reported
Not reported
Dyspnea
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
6.06
23.041
Not reported
Not reported
Not reported
Chemotherapy
1.52
21.767
Not reported
Not reported
Not reported
Loss of Appetite
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
12.88
30.682
Not reported
Not reported
Not reported
Chemotherapy
6.06
19.616
Not reported
Not reported
Not reported
Insomnia
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
6.06
26.190
Not reported
Not reported
Not reported
Chemotherapy
-15.15
24.618
Not reported
Not reported
Not reported
Constipation
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
11.36
30.452
Not reported
Not reported
Not reported
Chemotherapy
1.52
12.503
Not reported
Not reported
Not reported
Diarrhea
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
T-DXd
6.82
19.792
Not reported
Not reported
Not reported
Chemotherapy
13.64
28.469
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
17.389
value
-7.88
group Id
OG001
spread
13.520
value
-4.85
title
Physical Functioning
categories
measurements
group Id
OG000
spread
21.631
value
-14.77
group Id
OG001
spread
26.318
value
-12.12
title
Role Functioning
categories
measurements
group Id
OG000
spread
25.440
value
-6.06
group Id
OG001
spread
22.218
value
1.52
title
Emotional Functioning
categories
measurements
group Id
OG000
spread
22.872
value
-8.71
group Id
OG001
spread
19.009
value
-6.82
title
Cognitive Functioning
categories
measurements
group Id
OG000
spread
23.000
value
-10.98
group Id
OG001
spread
21.656
value
-7.58
title
Social Functioning
categories
measurements
group Id
OG000
spread
24.367
value
11.87
group Id
OG001
spread
18.444
value
8.59
title
Fatigue
categories
measurements
group Id
OG000
spread
21.025
value
-1.89
group Id
OG001
spread
24.922
value
-0.76
title
Pain
categories
measurements
group Id
OG000
spread
19.128
value
9.85
group Id
OG001
spread
12.037
value
-0.76
title
Nausea/Vomiting
categories
measurements
group Id
OG000
spread
23.529
value
-7.77
group Id
OG001
spread
22.150
value
-10.61
title
Global Health Status/QoL
categories
measurements
group Id
OG000
spread
23.041
value
6.06
group Id
OG001
spread
21.767
value
1.52
title
Dyspnea
categories
measurements
group Id
OG000
spread
30.682
value
12.88
group Id
OG001
spread
19.616
value
6.06
title
Loss of Appetite
categories
measurements
group Id
OG000
spread
26.190
value
6.06
group Id
OG001
spread
24.618
value
-15.15
title
Insomnia
denoms
counts
group Id
OG000
value
44
group Id
OG001
value
22
units
Participants
description
EORTC QLQ-C30 is a 30-item self-administered questionnaire grouped into 5 multi-item functional scales(physical,role,emotional,cognitive and social),3 multiitem symptom scales(fatigue,pain and nausea/vomiting),2-item global QoL scale,5 single items assessing additional symptoms reported by cancer participants(dyspnea,loss of appetite,insomnia,constipation and diarrhea). All but 2 questions have 4-point scales:1:not at all,2:a little,3:quite a bit,4:very much.2 questions concerning global health status and QoL have 7-point scales with responses ranging from 1:very poor to 7:excellent;higher score:better level of functioning/greater degree of symptoms.For each of 15 scales,final scores were averaged from scores of component items,transformed,range: 0 to 100;higher scores:better functioning,better health related (HR)QoL,or greater level of symptoms(higher scores:opposite interpretations for functioning/QoL and symptoms/problems).Baseline:last observed measurement prior to randomization.
dispersion Type
Standard Deviation
groups
description
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
id
OG000
title
T-DXd
description
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
id
OG001
title
Chemotherapy
param Type
MEAN
population Description
The ITT population included all randomized participants. Only participants with data collected in specified categories are reported.
reporting Status
POSTED
time Frame
Baseline (Day 1) and Week 91
title
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Score at Week 91
Triangle