Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record 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

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

primary · POSTED

The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.

Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.

→

secondary · POSTED

The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.

HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.

→

secondary · POSTED

The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (\<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (\>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.

HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.

→

secondary · POSTED

EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.

ITT Population

→

secondary · POSTED

EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.

ITT Population

→

secondary · POSTED

EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.

ITT 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-enhertu-251d081e
nct id: NCT01401166
trial label: Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
applicability: unclear
applicability note: Attached because the study's own record 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: 10
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0000
source section id
NCT01401166-om-0000
source outcome index
0
endpoint
Percentage of Participants by Preferred Method of Drug Administration
endpoint definition
The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, "All things considered, which method of administration did you prefer?" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.
time origin
Week 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.
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-251d081e
nct id
NCT01401166
outcome key
om-0001
source section id
NCT01401166-om-0001
source outcome index
1
endpoint
Percentage of HCPs by Most Satisfied Method of Drug Administration
endpoint definition
The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, "All things considered, with which method of administration were you most satisfied?" at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.
time origin
Week 24
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.
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-251d081e
nct id
NCT01401166
outcome key
om-0002
source section id
NCT01401166-om-0002
source outcome index
2
endpoint
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
endpoint definition
The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (\<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (\>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.
time origin
Week 24
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.
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-251d081e
nct id
NCT01401166
outcome key
om-0003
source section id
NCT01401166-om-0003
source outcome index
3
endpoint
Percentage of Participants With an Event-Free Survival (EFS) Event
endpoint definition
EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.
time origin
From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT 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-251d081e
nct id
NCT01401166
outcome key
om-0004
source section id
NCT01401166-om-0004
source outcome index
4
endpoint
Duration of EFS According to Kaplan-Meier Estimate
endpoint definition
EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.
time origin
From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT 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-251d081e
nct id
NCT01401166
outcome key
om-0005
source section id
NCT01401166-om-0005
source outcome index
5
endpoint
3-Year EFS Rate
endpoint definition
EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.
time origin
Year 3
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT 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-251d081e
nct id
NCT01401166
outcome key
om-0000
arm key
OG000
arm label
Cohort 1: SC (SID) Then IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0000
arm key
OG001
arm label
Cohort 1: IV Then SC (SID) Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
analyzed count
119
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0000
arm key
OG002
arm label
Cohort 2: SC (Vial) Then IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
analyzed count
118
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0000
arm key
OG003
arm label
Cohort 2: IV Then SC (Vial) Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
analyzed count
113
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0001
arm key
OG000
arm label
All HCPs: SC and IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0002
arm key
OG000
arm label
All HCPs: SC and IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0003
arm key
OG000
arm label
Cohort 1: SC (SID) Then IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0003
arm key
OG001
arm label
Cohort 1: IV Then SC (SID) Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
analyzed count
119
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0003
arm key
OG002
arm label
Cohort 2: SC (Vial) Then IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
analyzed count
118
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0003
arm key
OG003
arm label
Cohort 2: IV Then SC (Vial) Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
analyzed count
113
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0003#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0004
arm key
OG000
arm label
Cohort 1: SC (SID) Then IV Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
analyzed count
117
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
outcome key
om-0004
arm key
OG001
arm label
Cohort 1: IV Then SC (SID) Herceptin
regimen
Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
analyzed count
119
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01401166-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-enhertu-251d081e
nct id
NCT01401166
harm key
EG000
source section id
NCT01401166-ae
event group key
EG000
event group label
Cohort 1: SC (SID) Herceptin (Crossover)
serious affected
4
serious at risk
242
other affected
81
other at risk
242
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG001
source section id
NCT01401166-ae
event group key
EG001
event group label
Cohort 1: IV Herceptin (Crossover)
serious affected
2
serious at risk
241
other affected
55
other at risk
241
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG002
source section id
NCT01401166-ae
event group key
EG002
event group label
Cohort 1: IV Herceptin (Continuation)
serious affected
6
serious at risk
226
other affected
46
other at risk
226
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG003
source section id
NCT01401166-ae
event group key
EG003
event group label
Cohort 1: SC (SID) Herceptin (Continuation)
serious affected
1
serious at risk
43
other affected
7
other at risk
43
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG004
source section id
NCT01401166-ae
event group key
EG004
event group label
Cohort 1 Overall: SC (SID) and IV Herceptin
serious affected
12
serious at risk
244
other affected
130
other at risk
244
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG005
source section id
NCT01401166-ae
event group key
EG005
event group label
Cohort 2: SC (Vial) Herceptin (Crossover)
serious affected
0
serious at risk
237
other affected
107
other at risk
237
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG006
source section id
NCT01401166-ae
event group key
EG006
event group label
Cohort 2: IV Herceptin (Crossover)
serious affected
2
serious at risk
237
other affected
76
other at risk
237
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG007
source section id
NCT01401166-ae
event group key
EG007
event group label
Cohort 2: IV Herceptin (Continuation)
serious affected
0
serious at risk
10
other affected
6
other at risk
10
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG008
source section id
NCT01401166-ae
event group key
EG008
event group label
Cohort 2: SC (Vial) Herceptin (Continuation)
serious affected
5
serious at risk
208
other affected
61
other at risk
208
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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-251d081e
nct id
NCT01401166
harm key
EG009
source section id
NCT01401166-ae
event group key
EG009
event group label
Cohort 2 Overall: SC (Vial) and IV Herceptin
serious affected
7
serious at risk
239
other affected
154
other at risk
239
frequency threshold
5
collection period
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
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

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Preserved source evidence · Not medical advice