NCT02107703 · BASELINE

Baseline characteristics

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer · Source last updated 2025-10-21

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

denoms

counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants

groups

description
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
BG000
title
Abemaciclib + Fulvestrant
description
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
BG001
title
Placebo + Fulvestrant
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.2
value
59.3
group Id
BG001
spread
11.7
value
61.1
group Id
BG002
spread
11.4
value
59.9
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
57
group Id
BG001
value
25
group Id
BG002
value
82
title
Hispanic or Latino
measurements
group Id
BG000
value
303
group Id
BG001
value
162
group Id
BG002
value
465
title
Not Hispanic or Latino
measurements
group Id
BG000
value
83
group Id
BG001
value
36
group Id
BG002
value
119
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
443
group Id
BG001
value
223
group Id
BG002
value
666
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who had baseline Ethnicity data.
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
8
group Id
BG002
value
26
title
American Indian or Alaska Native
measurements
group Id
BG000
value
149
group Id
BG001
value
65
group Id
BG002
value
214
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
9
group Id
BG001
value
5
group Id
BG002
value
14
title
Black or African American
measurements
group Id
BG000
value
237
group Id
BG001
value
136
group Id
BG002
value
373
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
33
group Id
BG001
value
9
group Id
BG002
value
42
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
120
group Id
BG001
value
58
group Id
BG002
value
178
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
North America
categories
measurements
group Id
BG000
value
179
group Id
BG001
value
100
group Id
BG002
value
279
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
Europe
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
14
group Id
BG002
value
39
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
Taiwan
categories
measurements
group Id
BG000
value
64
group Id
BG001
value
31
group Id
BG002
value
95
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
58
group Id
BG001
value
20
group Id
BG002
value
78
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
South Korea
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

All randomized participants.

Complete source fields

denoms

counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants

groups

description
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
BG000
title
Abemaciclib + Fulvestrant
description
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
BG001
title
Placebo + Fulvestrant
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
11.2
value
59.3
group Id
BG001
spread
11.7
value
61.1
group Id
BG002
spread
11.4
value
59.9
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
57
group Id
BG001
value
25
group Id
BG002
value
82
title
Hispanic or Latino
measurements
group Id
BG000
value
303
group Id
BG001
value
162
group Id
BG002
value
465
title
Not Hispanic or Latino
measurements
group Id
BG000
value
83
group Id
BG001
value
36
group Id
BG002
value
119
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
443
group Id
BG001
value
223
group Id
BG002
value
666
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
All randomized participants who had baseline Ethnicity data.
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
8
group Id
BG002
value
26
title
American Indian or Alaska Native
measurements
group Id
BG000
value
149
group Id
BG001
value
65
group Id
BG002
value
214
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
9
group Id
BG001
value
5
group Id
BG002
value
14
title
Black or African American
measurements
group Id
BG000
value
237
group Id
BG001
value
136
group Id
BG002
value
373
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
33
group Id
BG001
value
9
group Id
BG002
value
42
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
120
group Id
BG001
value
58
group Id
BG002
value
178
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
North America
categories
measurements
group Id
BG000
value
179
group Id
BG001
value
100
group Id
BG002
value
279
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
Europe
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
14
group Id
BG002
value
39
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
Taiwan
categories
measurements
group Id
BG000
value
64
group Id
BG001
value
31
group Id
BG002
value
95
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
58
group Id
BG001
value
20
group Id
BG002
value
78
denoms
counts
group Id
BG000
value
446
group Id
BG001
value
223
group Id
BG002
value
669
units
Participants
title
South Korea
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

All randomized participants.

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

Preserved source evidence · Not medical advice