NCT00066703 · STUDY IN CONTEXT

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.

Intention-to-treat

→

secondary · POSTED

Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.

Intention-to-treat

→

secondary · POSTED

Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up

Intention-to-treat

→

secondary · POSTED

Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.

Intention-to-treat

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer
nct id: NCT00066703
trial label: Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0000
source section id
NCT00066703-om-0000
source outcome index
0
endpoint
Disease-free Survival
endpoint definition
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.
time origin
5-year estimate reported at a median follow-up of 72 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intention-to-treat
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0001
source section id
NCT00066703-om-0001
source outcome index
1
endpoint
Breast Cancer-free Interval
endpoint definition
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
time origin
5-year estimate reported at a median follow-up of 72 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intention-to-treat
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0002
source section id
NCT00066703-om-0002
source outcome index
2
endpoint
Distant Recurrence-free Interval
endpoint definition
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up
time origin
5-year estimates reported at a median follow-up of 72 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intention-to-treat
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0003
source section id
NCT00066703-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
time origin
8-year estimates, reported at a median follow-up of 9 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intention-to-treat
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0000
arm key
OG000
arm label
T+OFS
regimen
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.
analyzed count
1328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0000
arm key
OG001
arm label
E+OFS
regimen
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.
analyzed count
1332
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0001
arm key
OG000
arm label
T+OFS
regimen
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.
analyzed count
1328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0001
arm key
OG001
arm label
E+OFS
regimen
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.
analyzed count
1332
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0002
arm key
OG000
arm label
T+OFS
regimen
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.
analyzed count
1328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0002
arm key
OG001
arm label
E+OFS
regimen
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.
analyzed count
1332
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0003
arm key
OG000
arm label
T+OFS
regimen
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.
analyzed count
1328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
outcome key
om-0003
arm key
OG001
arm label
E+OFS
regimen
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.
analyzed count
1332
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00066703-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
harm key
EG000
source section id
NCT00066703-ae
event group key
EG000
event group label
T+OFS
serious affected
484
serious at risk
1321
other affected
1293
other at risk
1321
frequency threshold
0
collection period
Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.
event definition
Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00066703
harm key
EG001
source section id
NCT00066703-ae
event group key
EG001
event group label
E+OFS
serious affected
496
serious at risk
1317
other affected
1298
other at risk
1317
frequency threshold
0
collection period
Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.
event definition
Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice