TriangleNCT00066690 · STUDY IN CONTEXT
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
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.
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 invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
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 invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
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.
Reported safety
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
- NCT00066690
- trial label
- Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0000
- source section id
- NCT00066690-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 estimates, reported at a median follow-up of 67 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
- NCT00066690
- outcome key
- om-0001
- source section id
- NCT00066690-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 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 estimates, reported at a median follow-up of 67 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
- NCT00066690
- outcome key
- om-0002
- source section id
- NCT00066690-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 invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
- time origin
- 5-year estimates, reported at a median follow-up of 67 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
- NCT00066690
- outcome key
- om-0003
- source section id
- NCT00066690-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 8 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
- NCT00066690
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Tamoxifen
- regimen
- Tamoxifen 20mg orally daily for 5 years
- analyzed count
- 1018
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0000
- arm key
- OG001
- arm label
- T+OFS
- regimen
- Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
- analyzed count
- 1015
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0000
- arm key
- OG002
- arm label
- E+OFS
- regimen
- Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
- analyzed count
- 1014
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Tamoxifen
- regimen
- Tamoxifen 20mg orally daily for 5 years
- analyzed count
- 1018
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0001
- arm key
- OG001
- arm label
- T+OFS
- regimen
- Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
- analyzed count
- 1015
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0001
- arm key
- OG002
- arm label
- E+OFS
- regimen
- Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
- analyzed count
- 1014
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Tamoxifen
- regimen
- Tamoxifen 20mg orally daily for 5 years
- analyzed count
- 1018
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0002
- arm key
- OG001
- arm label
- T+OFS
- regimen
- Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
- analyzed count
- 1015
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0002
- arm key
- OG002
- arm label
- E+OFS
- regimen
- Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
- analyzed count
- 1014
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Tamoxifen
- regimen
- Tamoxifen 20mg orally daily for 5 years Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Tamoxifen: Tamoxifen 20mg orally daily for 5 years
- analyzed count
- 1018
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0003
- arm key
- OG001
- arm label
- T+OFS
- regimen
- Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Tamoxifen: Tamoxifen 20mg orally daily for 5 years Triptorelin: 3.75 mg by im injection q28 days for 5 years
- analyzed count
- 1015
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- outcome key
- om-0003
- arm key
- OG002
- arm label
- E+OFS
- regimen
- Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane: Exemestane 25mg orally daily for 5 years plus ovarian function suppression Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Triptorelin: 3.75 mg by im injection q28 days for 5 years
- analyzed count
- 1014
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00066690-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00066690
- harm key
- EG000
- source section id
- NCT00066690-ae
- event group key
- EG000
- event group label
- Tamoxifen
- serious affected
- 315
- serious at risk
- 1007
- other affected
- 951
- other at risk
- 1007
- frequency threshold
- 0
- collection period
- Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.
- event definition
- Targeted AEs and other grade 3 or higher AEs 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
- NCT00066690
- harm key
- EG001
- source section id
- NCT00066690-ae
- event group key
- EG001
- event group label
- T+OFS
- serious affected
- 375
- serious at risk
- 1007
- other affected
- 982
- other at risk
- 1007
- frequency threshold
- 0
- collection period
- Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.
- event definition
- Targeted AEs and other grade 3 or higher AEs 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
- NCT00066690
- harm key
- EG002
- source section id
- NCT00066690-ae
- event group key
- EG002
- event group label
- E+OFS
- serious affected
- 375
- serious at risk
- 1001
- other affected
- 980
- other at risk
- 1001
- frequency threshold
- 0
- collection period
- Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.
- event definition
- Targeted AEs and other grade 3 or higher AEs 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