TriangleNCT00045032 · STUDY IN CONTEXT
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
Draft scope assessment: unclear. Attached because the study's own record names HER2 and names HER2 and names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
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-enhertu-a67acfe2
- nct id
- NCT00045032
- trial label
- Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2 and names HER2 and names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0000
- source section id
- NCT00045032-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Disease-Free Survival (DFS) Events in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
- endpoint definition
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an Independent Data Monitoring Committee (IDMC) in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
- time origin
- From Baseline until time of event (median of 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0001
- source section id
- NCT00045032-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With DFS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
- endpoint definition
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
- time origin
- From Baseline until time of event (median of 1 year)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0002
- source section id
- NCT00045032-om-0002
- source outcome index
- 2
- endpoint
- DFS Rate According to Kaplan-Meier Analysis in Herceptin 1-Year Arm Compared to Observation: 1-Year Median Follow-Up
- endpoint definition
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95 percent (%) confidence interval (CI) were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 1-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed by the Sponsor in 2006 following database cleaning. The analysis of the Herceptin 2-Year Arm against the Observation Arm was performed for an IDMC in 2005 at a time the Sponsor was blinded. Therefore, these data are reported under a separate Outcome Measure.
- time origin
- Year 2
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0003
- source section id
- NCT00045032-om-0003
- source outcome index
- 3
- endpoint
- DFS Rate According to Kaplan-Meier Analysis in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up
- endpoint definition
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 1-year median follow-up analysis. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.
- time origin
- Year 2
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0004
- source section id
- NCT00045032-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With DFS Events Compared to Observation: 8-Year Median Follow-Up
- endpoint definition
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.
- time origin
- From Baseline until time of event (median of 8 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS Population
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0005
- source section id
- NCT00045032-om-0005
- source outcome index
- 5
- endpoint
- DFS Rate at Year 3 According to Kaplan-Meier Analysis Compared to Observation: 8-Year Median Follow-Up
- endpoint definition
- DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants free of DFS events (i.e., the DFS rate) and corresponding 95% CI were estimated by Kaplan-Meier analysis based on available data at the time of the 8-year median follow-up analysis.
- time origin
- Year 3
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS Population
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Observation Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- analyzed count
- 1693
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Herceptin 1-Year Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- analyzed count
- 1693
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Observation Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- analyzed count
- 1693
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Herceptin 2-Year Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- analyzed count
- 1694
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Observation Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- analyzed count
- 1693
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Herceptin 1-Year Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- analyzed count
- 1693
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Observation Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- analyzed count
- 1693
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Herceptin 2-Year Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- analyzed count
- 1694
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Observation Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- analyzed count
- 1697
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Herceptin 1-Year Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- analyzed count
- 1702
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0004
- arm key
- OG002
- arm label
- Herceptin 2-Year Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
- analyzed count
- 1700
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0004#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Observation Arm
- regimen
- Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
- analyzed count
- 1697
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00045032-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-a67acfe2
- nct id
- NCT00045032
- harm key
- EG000
- source section id
- NCT00045032-ae
- event group key
- EG000
- event group label
- Observation Arm
- serious affected
- 143
- serious at risk
- 1744
- other affected
- 1076
- other at risk
- 1744
- frequency threshold
- 5
- collection period
- From Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)
- event definition
- Analysis Population Description: Safety Population
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- harm key
- EG001
- source section id
- NCT00045032-ae
- event group key
- EG001
- event group label
- Herceptin 1-Year Arm
- serious affected
- 269
- serious at risk
- 1682
- other affected
- 1389
- other at risk
- 1682
- frequency threshold
- 5
- collection period
- From Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)
- event definition
- Analysis Population Description: Safety Population
- 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-enhertu-a67acfe2
- nct id
- NCT00045032
- harm key
- EG002
- source section id
- NCT00045032-ae
- event group key
- EG002
- event group label
- Herceptin 2-Year Arm
- serious affected
- 344
- serious at risk
- 1673
- other affected
- 1440
- other at risk
- 1673
- frequency threshold
- 5
- collection period
- From Baseline until end of treatment (maximum up to 2 years) with the exception of cardiac/cardiovascular events, second primary malignancies, pregnancies, and Herceptin-related adverse events (maximum up to 10 years)
- event definition
- Analysis Population Description: Safety Population
- 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