A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early B

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

Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).

Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.

→

primary · POSTED

Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.

Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.

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secondary · POSTED

Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.

Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary endpoint.

→

secondary · POSTED

Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.

PKPP Population: All participants with at least one measurable trastuzumab serum concentration.

→

secondary · POSTED

Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.

PKPP Population; only participants with a Cycle 13 pre-dose PK measurement were included in the analysis.

→

secondary · POSTED

Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough \>20 μg/mL was reported.

Primary PKPP 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-trazimera-29c48296
nct id: NCT00950300
trial label: A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early B
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0000
source section id
NCT00950300-om-0000
source outcome index
0
endpoint
Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery
endpoint definition
Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).
time origin
Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary 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-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0001
source section id
NCT00950300-om-0001
source outcome index
1
endpoint
Percentage of Participants With Pathological Complete Response (pCR)
endpoint definition
Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.
time origin
After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.
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-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0002
source section id
NCT00950300-om-0002
source outcome index
2
endpoint
Observed Ctrough of Trastuzumab After Surgery
endpoint definition
Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.
time origin
Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary 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-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0003
source section id
NCT00950300-om-0003
source outcome index
3
endpoint
Predicted Ctrough of Trastuzumab Prior to Surgery
endpoint definition
Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.
time origin
Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PKPP Population: All participants with at least one measurable trastuzumab serum concentration.
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-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0004
source section id
NCT00950300-om-0004
source outcome index
4
endpoint
Predicted Ctrough of Trastuzumab After Surgery
endpoint definition
Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.
time origin
Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
PKPP Population; only participants with a Cycle 13 pre-dose PK measurement were included in the analysis.
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-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0005
source section id
NCT00950300-om-0005
source outcome index
5
endpoint
Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery
endpoint definition
Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough \>20 μg/mL was reported.
time origin
Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Primary PKPP 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-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0000
arm key
OG000
arm label
Herceptin IV + Chemotherapy
regimen
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0000
arm key
OG001
arm label
Herceptin SC + Chemotherapy
regimen
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
234
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0001
arm key
OG000
arm label
Herceptin IV + Chemotherapy
regimen
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
263
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0001
arm key
OG001
arm label
Herceptin SC + Chemotherapy
regimen
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
260
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0002
arm key
OG000
arm label
Herceptin IV + Chemotherapy
regimen
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
223
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0002
arm key
OG001
arm label
Herceptin SC + Chemotherapy
regimen
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
227
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0003
arm key
OG000
arm label
Herceptin IV + Chemotherapy
regimen
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
276
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0003
arm key
OG001
arm label
Herceptin SC + Chemotherapy
regimen
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
278
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0004
arm key
OG000
arm label
Herceptin IV + Chemotherapy
regimen
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
236
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0004
arm key
OG001
arm label
Herceptin SC + Chemotherapy
regimen
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
236
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0005
arm key
OG000
arm label
Herceptin IV + Chemotherapy
regimen
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
235
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
outcome key
om-0005
arm key
OG001
arm label
Herceptin SC + Chemotherapy
regimen
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
analyzed count
234
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00950300-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trazimera-29c48296
nct id
NCT00950300
harm key
EG000
source section id
NCT00950300-ae
event group key
EG000
event group label
Herceptin IV + Chemotherapy
serious affected
45
serious at risk
298
other affected
277
other at risk
298
frequency threshold
5
collection period
Approximately 87 months overall
event definition
Analysis was performed on 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-trazimera-29c48296
nct id
NCT00950300
harm key
EG001
source section id
NCT00950300-ae
event group key
EG001
event group label
Herceptin SC + Chemotherapy
serious affected
65
serious at risk
297
other affected
283
other at risk
297
frequency threshold
5
collection period
Approximately 87 months overall
event definition
Analysis was performed on 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