NCT05113251 · BASELINE

Baseline characteristics

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer · Source last updated 2026-08-11

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

denoms

counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants

groups

description
Trastuzumab deruxtecan (5.4 mg/kg Q3W for 8 cycles)
id
BG000
title
Arm A
description
Trastuzumab deruxtecan (5.4 mg/kg Q3W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles
id
BG001
title
Arm B
description
Doxorubicin (60 mg/m2 Q2W) and cyclophosphamide (600 mg/m2 Q2W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles
id
BG002
title
Arm C
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
<=18 years
measurements
group Id
BG000
value
252
group Id
BG001
value
282
group Id
BG002
value
288
group Id
BG003
value
822
title
Between 18 and 65 years
measurements
group Id
BG000
value
34
group Id
BG001
value
39
group Id
BG002
value
32
group Id
BG003
value
105
title
>=65 years
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
denom Units Selected
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
11.25
value
50.3
group Id
BG001
spread
11.09
value
50.0
group Id
BG002
spread
11.32
value
50.1
group Id
BG003
spread
11.21
value
50.1
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
denom Units Selected
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Male
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
denom Units Selected
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
29
group Id
BG002
value
28
group Id
BG003
value
85
title
Hispanic or Latino
measurements
group Id
BG000
value
257
group Id
BG001
value
292
group Id
BG002
value
292
group Id
BG003
value
841
title
Not Hispanic or Latino
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
denom Units Selected
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
7
group Id
BG003
value
19
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
2
title
Native Hawaiian or other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
0
group Id
BG003
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
127
group Id
BG001
value
160
group Id
BG002
value
157
group Id
BG003
value
444
title
Asian
measurements
group Id
BG000
value
139
group Id
BG001
value
140
group Id
BG002
value
137
group Id
BG003
value
416
title
White
measurements
group Id
BG000
value
6
group Id
BG001
value
9
group Id
BG002
value
9
group Id
BG003
value
24
title
Other
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
group Id
BG003
value
18
title
Not reported
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
denom Units Selected
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.0934
value
160.248
group Id
BG001
spread
6.8713
value
159.793
group Id
BG002
spread
7.1728
value
160.441
group Id
BG003
spread
7.0434
value
160.158
denoms
counts
group Id
BG000
value
285
group Id
BG001
value
318
group Id
BG002
value
320
group Id
BG003
value
923
units
Participants
denom Units Selected
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Height was not reported for all subjects.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
15.2465
value
66.212
group Id
BG001
spread
12.3807
value
64.879
group Id
BG002
spread
14.5867
value
66.284
group Id
BG003
spread
14.0814
value
65.776
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
320
group Id
BG002
value
320
group Id
BG003
value
926
units
Participants
denom Units Selected
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Weight was not reported for all participants.
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
5.3100
value
25.717
group Id
BG001
spread
4.6143
value
25.383
group Id
BG002
spread
5.2130
value
25.724
group Id
BG003
spread
5.0432
value
25.604
denoms
counts
group Id
BG000
value
285
group Id
BG001
value
318
group Id
BG002
value
320
group Id
BG003
value
923
units
Participants
denom Units Selected
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
BMI was not reported for all participants.
title
BMI
unit Of Measure
kg/m2
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
43
group Id
BG002
value
47
group Id
BG003
value
127
title
China
measurements
group Id
BG000
value
14
group Id
BG001
value
22
group Id
BG002
value
20
group Id
BG003
value
56
title
India
measurements
group Id
BG000
value
25
group Id
BG001
value
21
group Id
BG002
value
25
group Id
BG003
value
71
title
Japan
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
17
group Id
BG003
value
51
title
Korea
measurements
group Id
BG000
value
13
group Id
BG001
value
17
group Id
BG002
value
17
group Id
BG003
value
47
title
Philippines
measurements
group Id
BG000
value
8
group Id
BG001
value
20
group Id
BG002
value
17
group Id
BG003
value
45
title
Taiwan
measurements
group Id
BG000
value
10
group Id
BG001
value
12
group Id
BG002
value
9
group Id
BG003
value
31
title
Thailand
measurements
group Id
BG000
value
20
group Id
BG001
value
19
group Id
BG002
value
13
group Id
BG003
value
52
title
Canada
measurements
group Id
BG000
value
32
group Id
BG001
value
24
group Id
BG002
value
28
group Id
BG003
value
84
title
United States of America
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
14
group Id
BG003
value
39
title
Brazil
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
Bulgaria
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
6
group Id
BG003
value
15
title
Peru
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
denom Units Selected
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
185
group Id
BG001
value
210
group Id
BG002
value
210
group Id
BG003
value
605
title
HER2-positive status: IHC 3+
measurements
group Id
BG000
value
23
group Id
BG001
value
26
group Id
BG002
value
25
group Id
BG003
value
74
title
HER2-positive status: Other
denoms
counts
group Id
BG000
value
208
group Id
BG001
value
236
group Id
BG002
value
235
group Id
BG003
value
679
units
Participants
title
Hormone receptor status: ER and/or PgR positive
categories
measurements
group Id
BG000
value
72
group Id
BG001
value
79
group Id
BG002
value
79
group Id
BG003
value
230
title
HER2-positive status: IHC 3+
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
6
group Id
BG003
value
18
title
HER2-positive status: Other
denoms
counts
group Id
BG000
value
78
group Id
BG001
value
85
group Id
BG002
value
85
group Id
BG003
value
248
units
Participants
title
Hormone receptor status: ER and PgR negative
categories
measurements
group Id
BG000
value
257
group Id
BG001
value
289
group Id
BG002
value
289
group Id
BG003
value
835
title
HER2-positive status: IHC 3+
measurements
group Id
BG000
value
29
group Id
BG001
value
32
group Id
BG002
value
31
group Id
BG003
value
92
title
HER2-positive status: Other
denoms
counts
group Id
BG000
value
286
group Id
BG001
value
321
group Id
BG002
value
320
group Id
BG003
value
927
units
Participants
title
Hormone receptor status: Total
denom Units Selected
Participants
description
This is a summary of the stratification factors recorded at randomisation by the Interactive Response Technology (IRT).
param Type
COUNT_OF_PARTICIPANTS
population Description
The number analyzed presents the total number of patients within each category.
title
Hormone receptor status by local assessment and central assessment of HER2- positive status
unit Of Measure
Participants

population Description

This population includes all randomized patients.

type Units Analyzed

927

Complete source fields