NCT01272037 · BASELINE

Baseline characteristics

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer · Source last updated 2026-08-28

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

denoms

counts
group Id
BG000
value
2511
group Id
BG001
value
2507
group Id
BG002
value
5018
units
Participants

groups

description
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
id
BG000
title
Chemo and Endocrine Therapy
description
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
id
BG001
title
Endocrine Therapy Alone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
28.0
upper Limit
87.6
value
57.9
group Id
BG001
lower Limit
18.3
upper Limit
86.0
value
57.2
group Id
BG002
lower Limit
18.3
upper Limit
87.6
value
57.5
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
80
group Id
BG002
value
147
title
< 40 years
measurements
group Id
BG000
value
530
group Id
BG001
value
547
group Id
BG002
value
1077
title
40-49 years
measurements
group Id
BG000
value
837
group Id
BG001
value
838
group Id
BG002
value
1675
title
50-59 years
measurements
group Id
BG000
value
777
group Id
BG001
value
761
group Id
BG002
value
1538
title
60-69 years
measurements
group Id
BG000
value
300
group Id
BG001
value
281
group Id
BG002
value
581
title
>= 70 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2511
group Id
BG001
value
2507
group Id
BG002
value
5018
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
description
This trial only included female participants.
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
297
group Id
BG001
value
325
group Id
BG002
value
622
title
Hispanic or Latino
measurements
group Id
BG000
value
1731
group Id
BG001
value
1695
group Id
BG002
value
3426
title
Not Hispanic or Latino
measurements
group Id
BG000
value
483
group Id
BG001
value
487
group Id
BG002
value
970
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1667
group Id
BG001
value
1628
group Id
BG002
value
3295
title
White
measurements
group Id
BG000
value
130
group Id
BG001
value
121
group Id
BG002
value
251
title
Black
measurements
group Id
BG000
value
154
group Id
BG001
value
170
group Id
BG002
value
324
title
Asian
measurements
group Id
BG000
value
560
group Id
BG001
value
588
group Id
BG002
value
1148
title
Other/Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
834
group Id
BG001
value
831
group Id
BG002
value
1665
title
Premenopausal
measurements
group Id
BG000
value
1677
group Id
BG001
value
1676
group Id
BG002
value
3353
title
Postmenopausal
description
Premenopausal was defined as: \< 6 months since last menstrual period and no prior bilateral oophorectomy and not on estrogen replacement. Postmenopausal was defined as: prior bilateral oophorectomy, or \> 12 months since last menstrual period with no prior hysterectomy. If these categories did not apply, premenopausal was defined as age \< 50 and postmenopausal was defined as age \>= 50.
param Type
COUNT_OF_PARTICIPANTS
title
Menopausal Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1076
group Id
BG001
value
1071
group Id
BG002
value
2147
title
0-13
measurements
group Id
BG000
value
1435
group Id
BG001
value
1436
group Id
BG002
value
2871
title
14-25
description
The Oncotype DX® Recurrence Score is based on a 21-gene breast cancer assay. The score ranges from 0-100, with higher scores indicating a worse prognosis. This study included participants with a score of 0-25.
param Type
COUNT_OF_PARTICIPANTS
title
Recurrence Score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1569
group Id
BG001
value
1571
group Id
BG002
value
3140
title
Axillary lymph-node dissection, with or without sentinel-node mapping
measurements
group Id
BG000
value
942
group Id
BG001
value
936
group Id
BG002
value
1878
title
Sentinel-node biopsy without axillary lymph-node dissection
param Type
COUNT_OF_PARTICIPANTS
title
Axillary Surgery
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1628
group Id
BG001
value
1647
group Id
BG002
value
3275
title
1 node
measurements
group Id
BG000
value
643
group Id
BG001
value
623
group Id
BG002
value
1266
title
2 nodes
measurements
group Id
BG000
value
231
group Id
BG001
value
229
group Id
BG002
value
460
title
3 nodes
measurements
group Id
BG000
value
9
group Id
BG001
value
8
group Id
BG002
value
17
title
Not reported
param Type
COUNT_OF_PARTICIPANTS
title
Positive Nodes
unit Of Measure
Participants

population Description

Randomized participants who were eligible for the study.

Complete source fields

denoms

counts
group Id
BG000
value
2511
group Id
BG001
value
2507
group Id
BG002
value
5018
units
Participants

groups

description
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
id
BG000
title
Chemo and Endocrine Therapy
description
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
id
BG001
title
Endocrine Therapy Alone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
28.0
upper Limit
87.6
value
57.9
group Id
BG001
lower Limit
18.3
upper Limit
86.0
value
57.2
group Id
BG002
lower Limit
18.3
upper Limit
87.6
value
57.5
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
80
group Id
BG002
value
147
title
< 40 years
measurements
group Id
BG000
value
530
group Id
BG001
value
547
group Id
BG002
value
1077
title
40-49 years
measurements
group Id
BG000
value
837
group Id
BG001
value
838
group Id
BG002
value
1675
title
50-59 years
measurements
group Id
BG000
value
777
group Id
BG001
value
761
group Id
BG002
value
1538
title
60-69 years
measurements
group Id
BG000
value
300
group Id
BG001
value
281
group Id
BG002
value
581
title
>= 70 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2511
group Id
BG001
value
2507
group Id
BG002
value
5018
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
description
This trial only included female participants.
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
297
group Id
BG001
value
325
group Id
BG002
value
622
title
Hispanic or Latino
measurements
group Id
BG000
value
1731
group Id
BG001
value
1695
group Id
BG002
value
3426
title
Not Hispanic or Latino
measurements
group Id
BG000
value
483
group Id
BG001
value
487
group Id
BG002
value
970
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1667
group Id
BG001
value
1628
group Id
BG002
value
3295
title
White
measurements
group Id
BG000
value
130
group Id
BG001
value
121
group Id
BG002
value
251
title
Black
measurements
group Id
BG000
value
154
group Id
BG001
value
170
group Id
BG002
value
324
title
Asian
measurements
group Id
BG000
value
560
group Id
BG001
value
588
group Id
BG002
value
1148
title
Other/Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
834
group Id
BG001
value
831
group Id
BG002
value
1665
title
Premenopausal
measurements
group Id
BG000
value
1677
group Id
BG001
value
1676
group Id
BG002
value
3353
title
Postmenopausal
description
Premenopausal was defined as: \< 6 months since last menstrual period and no prior bilateral oophorectomy and not on estrogen replacement. Postmenopausal was defined as: prior bilateral oophorectomy, or \> 12 months since last menstrual period with no prior hysterectomy. If these categories did not apply, premenopausal was defined as age \< 50 and postmenopausal was defined as age \>= 50.
param Type
COUNT_OF_PARTICIPANTS
title
Menopausal Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1076
group Id
BG001
value
1071
group Id
BG002
value
2147
title
0-13
measurements
group Id
BG000
value
1435
group Id
BG001
value
1436
group Id
BG002
value
2871
title
14-25
description
The Oncotype DX® Recurrence Score is based on a 21-gene breast cancer assay. The score ranges from 0-100, with higher scores indicating a worse prognosis. This study included participants with a score of 0-25.
param Type
COUNT_OF_PARTICIPANTS
title
Recurrence Score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1569
group Id
BG001
value
1571
group Id
BG002
value
3140
title
Axillary lymph-node dissection, with or without sentinel-node mapping
measurements
group Id
BG000
value
942
group Id
BG001
value
936
group Id
BG002
value
1878
title
Sentinel-node biopsy without axillary lymph-node dissection
param Type
COUNT_OF_PARTICIPANTS
title
Axillary Surgery
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1628
group Id
BG001
value
1647
group Id
BG002
value
3275
title
1 node
measurements
group Id
BG000
value
643
group Id
BG001
value
623
group Id
BG002
value
1266
title
2 nodes
measurements
group Id
BG000
value
231
group Id
BG001
value
229
group Id
BG002
value
460
title
3 nodes
measurements
group Id
BG000
value
9
group Id
BG001
value
8
group Id
BG002
value
17
title
Not reported
param Type
COUNT_OF_PARTICIPANTS
title
Positive Nodes
unit Of Measure
Participants

population Description

Randomized participants who were eligible for the study.

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

Preserved source evidence · Not medical advice