NCT04305496 · BASELINE

Baseline characteristics

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer · Source last updated 2026-04-30

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

denoms

counts
group Id
BG000
value
410
group Id
BG001
value
408
group Id
BG002
value
818
units
Participants

groups

description
Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
id
BG000
title
Capivasertib + Fulvestrant (Global + China Cohort)
description
Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
id
BG001
title
Placebo + Fulvestrant (Global Cohort + China Cohort )
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.25
value
58.6
group Id
BG001
spread
11.91
value
57.4
group Id
BG002
spread
11.59
value
58.0
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
spread
10.66
value
54.7
group Id
BG001
spread
10.60
value
55.0
group Id
BG002
spread
10.59
value
54.8
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The results are presented by Global cohort and by China cohort
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
99
group Id
BG002
value
175
title
<50 years
measurements
group Id
BG000
value
164
group Id
BG001
value
152
group Id
BG002
value
316
title
>=50-<65 years
measurements
group Id
BG000
value
91
group Id
BG001
value
76
group Id
BG002
value
167
title
>=65-<75 years
measurements
group Id
BG000
value
24
group Id
BG001
value
26
group Id
BG002
value
50
title
>=75 years
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
24
group Id
BG002
value
43
title
<50 years
measurements
group Id
BG000
value
39
group Id
BG001
value
21
group Id
BG002
value
60
title
>=50-<65 years
measurements
group Id
BG000
value
12
group Id
BG001
value
18
group Id
BG002
value
30
title
>=65-<75 years
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
>=75 years
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
description
Age at Screening
param Type
COUNT_OF_PARTICIPANTS
population Description
Overall population
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
352
group Id
BG001
value
349
group Id
BG002
value
701
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Male
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
71
group Id
BG001
value
62
group Id
BG002
value
133
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Male
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The results are presented by Global cohort and by China cohort
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
31
group Id
BG002
value
62
title
Hispanic or Latino
measurements
group Id
BG000
value
323
group Id
BG001
value
322
group Id
BG002
value
645
title
Not Hispanic or Latino
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
69
group Id
BG001
value
61
group Id
BG002
value
130
title
Not Hispanic or Latino
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The results are presented by Global cohort and by China cohort
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
95
group Id
BG001
value
94
group Id
BG002
value
189
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Black or African American
measurements
group Id
BG000
value
201
group Id
BG001
value
206
group Id
BG002
value
407
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
52
group Id
BG001
value
47
group Id
BG002
value
99
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
69
group Id
BG001
value
61
group Id
BG002
value
130
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The results are presented by Global cohort and by China cohort
title
Race (NIH/OMB)
unit Of Measure
Participants

population Description

Full analysis set. 24 participants (16 participants in the capivasertib arm and 8 participants in the placebo arm) were included in both the Global and China cohorts.

Complete source fields

denoms

counts
group Id
BG000
value
410
group Id
BG001
value
408
group Id
BG002
value
818
units
Participants

groups

description
Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
id
BG000
title
Capivasertib + Fulvestrant (Global + China Cohort)
description
Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
id
BG001
title
Placebo + Fulvestrant (Global Cohort + China Cohort )
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.25
value
58.6
group Id
BG001
spread
11.91
value
57.4
group Id
BG002
spread
11.59
value
58.0
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
spread
10.66
value
54.7
group Id
BG001
spread
10.60
value
55.0
group Id
BG002
spread
10.59
value
54.8
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The results are presented by Global cohort and by China cohort
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
99
group Id
BG002
value
175
title
<50 years
measurements
group Id
BG000
value
164
group Id
BG001
value
152
group Id
BG002
value
316
title
>=50-<65 years
measurements
group Id
BG000
value
91
group Id
BG001
value
76
group Id
BG002
value
167
title
>=65-<75 years
measurements
group Id
BG000
value
24
group Id
BG001
value
26
group Id
BG002
value
50
title
>=75 years
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
24
group Id
BG002
value
43
title
<50 years
measurements
group Id
BG000
value
39
group Id
BG001
value
21
group Id
BG002
value
60
title
>=50-<65 years
measurements
group Id
BG000
value
12
group Id
BG001
value
18
group Id
BG002
value
30
title
>=65-<75 years
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
>=75 years
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
description
Age at Screening
param Type
COUNT_OF_PARTICIPANTS
population Description
Overall population
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
352
group Id
BG001
value
349
group Id
BG002
value
701
title
Female
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Male
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
71
group Id
BG001
value
62
group Id
BG002
value
133
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Male
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The results are presented by Global cohort and by China cohort
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
31
group Id
BG002
value
62
title
Hispanic or Latino
measurements
group Id
BG000
value
323
group Id
BG001
value
322
group Id
BG002
value
645
title
Not Hispanic or Latino
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Hispanic or Latino
measurements
group Id
BG000
value
69
group Id
BG001
value
61
group Id
BG002
value
130
title
Not Hispanic or Latino
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The results are presented by Global cohort and by China cohort
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
95
group Id
BG001
value
94
group Id
BG002
value
189
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Black or African American
measurements
group Id
BG000
value
201
group Id
BG001
value
206
group Id
BG002
value
407
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
52
group Id
BG001
value
47
group Id
BG002
value
99
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
355
group Id
BG001
value
353
group Id
BG002
value
708
units
Participants
title
Global cohort
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
69
group Id
BG001
value
61
group Id
BG002
value
130
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Black or African American
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
71
group Id
BG001
value
63
group Id
BG002
value
134
units
Participants
title
China cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The results are presented by Global cohort and by China cohort
title
Race (NIH/OMB)
unit Of Measure
Participants

population Description

Full analysis set. 24 participants (16 participants in the capivasertib arm and 8 participants in the placebo arm) were included in both the Global and China cohorts.

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Preserved source evidence · Not medical advice