Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Obtained scores are linearly transformed to a score range of 0-100. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL.
Analysis population: ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.
Groups in this outcome
Trastuzumab
Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
Trastuzumab Emtansine
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
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
Trastuzumab
743
Trastuzumab Emtansine
743
Reported measurements
Baseline: Body Image
Analysis denominator · Participants
Group
Source count
Trastuzumab
622
Trastuzumab Emtansine
645
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
69.8
28.5
Not reported
Not reported
Not reported
Trastuzumab Emtansine
67.5
28.5
Not reported
Not reported
Not reported
Change at Cycle 5: Body Image
Analysis denominator · Participants
Group
Source count
Trastuzumab
555
Trastuzumab Emtansine
571
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
1.5
20.5
Not reported
Not reported
Not reported
Trastuzumab Emtansine
4.6
22.7
Not reported
Not reported
Not reported
Change at Cycle 11: Body Image
Analysis denominator · Participants
Group
Source count
Trastuzumab
493
Trastuzumab Emtansine
495
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
3.4
24.4
Not reported
Not reported
Not reported
Trastuzumab Emtansine
5.7
23.9
Not reported
Not reported
Not reported
Change at FU Month 6: Body Image
Analysis denominator · Participants
Group
Source count
Trastuzumab
409
Trastuzumab Emtansine
462
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
3.6
25.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
7.8
25.8
Not reported
Not reported
Not reported
Change at FU Month 12: Body Image
Analysis denominator · Participants
Group
Source count
Trastuzumab
383
Trastuzumab Emtansine
428
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
6.2
27.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
6.1
27.2
Not reported
Not reported
Not reported
Baseline: FP
Analysis denominator · Participants
Group
Source count
Trastuzumab
622
Trastuzumab Emtansine
645
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
51.3
31.2
Not reported
Not reported
Not reported
Trastuzumab Emtansine
50.1
31.7
Not reported
Not reported
Not reported
Change at Cycle 5: FP
Analysis denominator · Participants
Group
Source count
Trastuzumab
555
Trastuzumab Emtansine
571
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
2.6
28.3
Not reported
Not reported
Not reported
Trastuzumab Emtansine
6.5
29.9
Not reported
Not reported
Not reported
Change at Cycle 11: FP
Analysis denominator · Participants
Group
Source count
Trastuzumab
493
Trastuzumab Emtansine
495
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
6.3
30.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
6.1
31.4
Not reported
Not reported
Not reported
Change at FU Month 6: FP
Analysis denominator · Participants
Group
Source count
Trastuzumab
409
Trastuzumab Emtansine
462
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
7.7
33.5
Not reported
Not reported
Not reported
Trastuzumab Emtansine
8.1
34.6
Not reported
Not reported
Not reported
Change at FU Month 12: FP
Analysis denominator · Participants
Group
Source count
Trastuzumab
383
Trastuzumab Emtansine
428
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
8.1
31.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
8.2
33.0
Not reported
Not reported
Not reported
Baseline: Sexual Enjoyment
Analysis denominator · Participants
Group
Source count
Trastuzumab
218
Trastuzumab Emtansine
241
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
50.9
28.8
Not reported
Not reported
Not reported
Trastuzumab Emtansine
52.3
28.5
Not reported
Not reported
Not reported
Change at Cycle 5: Sexual Enjoyment
Analysis denominator · Participants
Group
Source count
Trastuzumab
147
Trastuzumab Emtansine
172
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
2.3
26.4
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-1.9
24.6
Not reported
Not reported
Not reported
Change at Cycle 11: Sexual Enjoyment
Analysis denominator · Participants
Group
Source count
Trastuzumab
128
Trastuzumab Emtansine
137
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
4.4
27.5
Not reported
Not reported
Not reported
Trastuzumab Emtansine
4.4
24.5
Not reported
Not reported
Not reported
Change at FU Month 6: Sexual Enjoyment
Analysis denominator · Participants
Group
Source count
Trastuzumab
104
Trastuzumab Emtansine
126
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
3.2
28.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
0.3
27.5
Not reported
Not reported
Not reported
Change at FU Month 12: Sexual Enjoyment
Analysis denominator · Participants
Group
Source count
Trastuzumab
95
Trastuzumab Emtansine
114
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
5.6
26.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
1.8
26.2
Not reported
Not reported
Not reported
Baseline: Sexual Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
550
Trastuzumab Emtansine
564
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
20.2
23.6
Not reported
Not reported
Not reported
Trastuzumab Emtansine
22.0
23.4
Not reported
Not reported
Not reported
Change at Cycle 5: Sexual Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
456
Trastuzumab Emtansine
466
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
3.3
20.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
2.3
20.0
Not reported
Not reported
Not reported
Change at Cycle 11: Sexual Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
393
Trastuzumab Emtansine
382
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
3.1
20.8
Not reported
Not reported
Not reported
Trastuzumab Emtansine
1.9
20.3
Not reported
Not reported
Not reported
Change at FU Month 6: Sexual Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
321
Trastuzumab Emtansine
360
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
5.1
23.9
Not reported
Not reported
Not reported
Trastuzumab Emtansine
4.3
23.1
Not reported
Not reported
Not reported
Change at FU Month 12: Sexual Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
289
Trastuzumab Emtansine
319
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
5.9
23.7
Not reported
Not reported
Not reported
Trastuzumab Emtansine
5.2
22.7
Not reported
Not reported
Not reported
Baseline: Arm Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
622
Trastuzumab Emtansine
645
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
24.6
21.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
24.5
21.0
Not reported
Not reported
Not reported
Change at Cycle 5: Arm Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
555
Trastuzumab Emtansine
571
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-2.8
20.9
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-2.6
23.0
Not reported
Not reported
Not reported
Change at Cycle 11: Arm Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
493
Trastuzumab Emtansine
495
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-2.6
21.2
Not reported
Not reported
Not reported
Trastuzumab Emtansine
0.2
24.2
Not reported
Not reported
Not reported
Change at FU Month 6: Arm Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
409
Trastuzumab Emtansine
462
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-3.0
23.5
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-1.3
24.2
Not reported
Not reported
Not reported
Change at FU Month 12: Arm Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
383
Trastuzumab Emtansine
428
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-5.7
22.8
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-1.5
22.6
Not reported
Not reported
Not reported
Baseline: Breast Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
622
Trastuzumab Emtansine
645
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
22.7
19.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
21.4
17.9
Not reported
Not reported
Not reported
Change at Cycle 5: Breast Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
555
Trastuzumab Emtansine
571
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-1.1
20.3
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-1.1
19.1
Not reported
Not reported
Not reported
Change at Cycle 11: Breast Symptoms
Analysis denominator · Participants
Group
Source count
Trastuzumab
493
Trastuzumab Emtansine
495
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-3.7
19.8
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-0.6
19.5
Not reported
Not reported
Not reported
Change at FU Month 6: Breast Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
409
Trastuzumab Emtansine
462
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-6.5
20.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-2.2
19.7
Not reported
Not reported
Not reported
Change at Follow-up Month 12: Breast Function
Analysis denominator · Participants
Group
Source count
Trastuzumab
383
Trastuzumab Emtansine
428
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-8.3
19.9
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-3.8
19.2
Not reported
Not reported
Not reported
Baseline: Systemic Therapy Side Effects (SE)
Analysis denominator · Participants
Group
Source count
Trastuzumab
622
Trastuzumab Emtansine
645
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
16.7
13.7
Not reported
Not reported
Not reported
Trastuzumab Emtansine
16.9
14.1
Not reported
Not reported
Not reported
Change at Cycle 5: Systemic Therapy SE
Analysis denominator · Participants
Group
Source count
Trastuzumab
555
Trastuzumab Emtansine
571
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
0.7
13.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
5.5
15.3
Not reported
Not reported
Not reported
Change at Cycle 11: Systemic Therapy SE
Analysis denominator · Participants
Group
Source count
Trastuzumab
493
Trastuzumab Emtansine
495
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
1.2
12.2
Not reported
Not reported
Not reported
Trastuzumab Emtansine
4.2
15.4
Not reported
Not reported
Not reported
Change at FU Month 6: Systemic Therapy SE
Analysis denominator · Participants
Group
Source count
Trastuzumab
409
Trastuzumab Emtansine
462
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
1.9
13.9
Not reported
Not reported
Not reported
Trastuzumab Emtansine
1.1
15.3
Not reported
Not reported
Not reported
Change at FU Month 12: Systemic Therapy SE
Analysis denominator · Participants
Group
Source count
Trastuzumab
383
Trastuzumab Emtansine
428
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
1.3
13.9
Not reported
Not reported
Not reported
Trastuzumab Emtansine
1.4
16.3
Not reported
Not reported
Not reported
Baseline: Upset by Hair Loss Item
Analysis denominator · Participants
Group
Source count
Trastuzumab
77
Trastuzumab Emtansine
96
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
40.3
35.6
Not reported
Not reported
Not reported
Trastuzumab Emtansine
50.7
38.4
Not reported
Not reported
Not reported
Change at Cycle 5: Upset by Hair Loss Item
Analysis denominator · Participants
Group
Source count
Trastuzumab
13
Trastuzumab Emtansine
17
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-5.1
38.1
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-17.6
39.3
Not reported
Not reported
Not reported
Change at Cycle 11: Upset by Hair Loss Item
Analysis denominator · Participants
Group
Source count
Trastuzumab
14
Trastuzumab Emtansine
14
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-28.6
45.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-14.3
33.9
Not reported
Not reported
Not reported
Change at FU Month 6: Upset by Hair Loss Item
Analysis denominator · Participants
Group
Source count
Trastuzumab
25
Trastuzumab Emtansine
22
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-12.0
47.0
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-15.2
42.1
Not reported
Not reported
Not reported
Change at FU Month 12: Upset by Hair Loss Item
Analysis denominator · Participants
Group
Source count
Trastuzumab
23
Trastuzumab Emtansine
21
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab
-2.9
37.5
Not reported
Not reported
Not reported
Trastuzumab Emtansine
-14.3
41.6
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
28.5
value
69.8
group Id
OG001
spread
28.5
value
67.5
denoms
counts
group Id
OG000
value
622
group Id
OG001
value
645
units
Participants
title
Baseline: Body Image
categories
measurements
group Id
OG000
spread
20.5
value
1.5
group Id
OG001
spread
22.7
value
4.6
denoms
counts
group Id
OG000
value
555
group Id
OG001
value
571
units
Participants
title
Change at Cycle 5: Body Image
categories
measurements
group Id
OG000
spread
24.4
value
3.4
group Id
OG001
spread
23.9
value
5.7
denoms
counts
group Id
OG000
value
493
group Id
OG001
value
495
units
Participants
title
Change at Cycle 11: Body Image
categories
measurements
group Id
OG000
spread
25.1
value
3.6
group Id
OG001
spread
25.8
value
7.8
denoms
counts
group Id
OG000
value
409
group Id
OG001
value
462
units
Participants
title
Change at FU Month 6: Body Image
categories
measurements
group Id
OG000
spread
27.1
value
6.2
group Id
OG001
spread
27.2
value
6.1
denoms
counts
group Id
OG000
value
383
group Id
OG001
value
428
units
Participants
title
Change at FU Month 12: Body Image
categories
measurements
group Id
OG000
spread
31.2
value
51.3
group Id
OG001
spread
31.7
value
50.1
denoms
counts
group Id
OG000
value
622
group Id
OG001
value
645
units
Participants
title
Baseline: FP
categories
measurements
group Id
OG000
spread
28.3
value
2.6
group Id
OG001
spread
29.9
value
6.5
denoms
counts
group Id
OG000
value
555
group Id
OG001
value
571
units
Participants
title
Change at Cycle 5: FP
categories
measurements
group Id
OG000
spread
30.0
value
6.3
group Id
OG001
spread
31.4
value
6.1
denoms
counts
group Id
OG000
value
493
group Id
OG001
value
495
units
Participants
title
Change at Cycle 11: FP
categories
measurements
group Id
OG000
spread
33.5
value
7.7
group Id
OG001
spread
34.6
value
8.1
denoms
counts
group Id
OG000
value
409
group Id
OG001
value
462
units
Participants
title
Change at FU Month 6: FP
categories
measurements
group Id
OG000
spread
31.1
value
8.1
group Id
OG001
spread
33.0
value
8.2
denoms
counts
group Id
OG000
value
383
group Id
OG001
value
428
units
Participants
title
Change at FU Month 12: FP
categories
measurements
group Id
OG000
spread
28.8
value
50.9
group Id
OG001
spread
28.5
value
52.3
denoms
counts
group Id
OG000
value
218
group Id
OG001
value
241
units
Participants
title
Baseline: Sexual Enjoyment
categories
measurements
group Id
OG000
spread
26.4
value
2.3
group Id
OG001
spread
24.6
value
-1.9
denoms
counts
group Id
OG000
value
147
group Id
OG001
value
172
units
Participants
title
Change at Cycle 5: Sexual Enjoyment
denoms
counts
group Id
OG000
value
743
group Id
OG001
value
743
units
Participants
description
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Obtained scores are linearly transformed to a score range of 0-100. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL.
dispersion Type
Standard Deviation
groups
description
Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
OG000
title
Trastuzumab
description
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
OG001
title
Trastuzumab Emtansine
param Type
MEAN
population Description
ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.