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. 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

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

primary · POSTED

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.

FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.

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primary · POSTED

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.

FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.

→

primary · POSTED

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.

FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.

→

primary · POSTED

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.

FAS Population. The "Number of Participants Analyzed" reflects the number with data for the endpoint.

→

primary · POSTED

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.

FAS Population

→

primary · POSTED

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.

FAS Population

→

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-ibrance-b5b7d18c
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. 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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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-ibrance-b5b7d18c
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