NCT00066703 · BASELINE

Baseline characteristics

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-02-06

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

denoms

counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
5320
units
Participants

groups

description
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
id
BG000
title
T+OFS
description
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
id
BG001
title
E+OFS
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
40
upper Limit
46
value
44
group Id
BG001
lower Limit
39
upper Limit
46
value
43
group Id
BG002
lower Limit
40
upper Limit
46
value
43
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Age
dispersion Type
INTER_QUARTILE_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
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
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
52
group Id
BG001
value
52
group Id
BG002
value
104
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Negative
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
48
group Id
BG002
value
96
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Positive
description
Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
Lymph-node status
unit Of Measure
percent of participants
classes
categories
measurements
group Id
BG000
value
60
group Id
BG001
value
59
group Id
BG002
value
119
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
<=2 cm
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
40
group Id
BG002
value
79
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
>=2 cm
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
unknown
description
Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
Tumor size
unit Of Measure
percent of participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
34
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
1
categories
measurements
group Id
BG000
value
56
group Id
BG001
value
55
group Id
BG002
value
111
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
2
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
27
group Id
BG002
value
53
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
3
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
unknown
description
Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis. Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
Tumor grade
unit Of Measure
percent of participants
classes
categories
measurements
group Id
BG000
value
87
group Id
BG001
value
87
group Id
BG002
value
174
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Negative
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
12
group Id
BG002
value
24
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Positive
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Unknown
description
Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
HER2 status
unit Of Measure
percent of participants

population Description

Intention-to-treat population excludes 12 patients who immediately withdrew consent, were at a non-adherent center, or had inadequate documentation of informed consent.

Complete source fields

denoms

counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
5320
units
Participants

groups

description
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
id
BG000
title
T+OFS
description
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
id
BG001
title
E+OFS
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
40
upper Limit
46
value
44
group Id
BG001
lower Limit
39
upper Limit
46
value
43
group Id
BG002
lower Limit
40
upper Limit
46
value
43
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Age
dispersion Type
INTER_QUARTILE_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
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
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
52
group Id
BG001
value
52
group Id
BG002
value
104
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Negative
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
48
group Id
BG002
value
96
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Positive
description
Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
Lymph-node status
unit Of Measure
percent of participants
classes
categories
measurements
group Id
BG000
value
60
group Id
BG001
value
59
group Id
BG002
value
119
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
<=2 cm
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
40
group Id
BG002
value
79
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
>=2 cm
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
unknown
description
Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
Tumor size
unit Of Measure
percent of participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
34
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
1
categories
measurements
group Id
BG000
value
56
group Id
BG001
value
55
group Id
BG002
value
111
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
2
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
27
group Id
BG002
value
53
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
3
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
unknown
description
Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis. Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
Tumor grade
unit Of Measure
percent of participants
classes
categories
measurements
group Id
BG000
value
87
group Id
BG001
value
87
group Id
BG002
value
174
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Negative
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
12
group Id
BG002
value
24
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Positive
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
1328
group Id
BG001
value
1332
group Id
BG002
value
2660
units
Participants
title
Unknown
description
Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
param Type
NUMBER
title
HER2 status
unit Of Measure
percent of participants

population Description

Intention-to-treat population excludes 12 patients who immediately withdrew consent, were at a non-adherent center, or had inadequate documentation of informed consent.

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Preserved source evidence · Not medical advice