A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive 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

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders

ITT Population; Analysis was performed according to initial randomization.

→

primary · POSTED

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.

ITT Population; Analysis was performed according to initial randomization. Number (n) equal (=) number of participants included in the specified type of breast cancer.

→

primary · POSTED

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.

ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.

→

primary · POSTED

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.

ITT Population; Analysis was performed according to initial randomization.

→

primary · POSTED

pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.

ITT Population; Analysis was performed according to initial randomization.

→

secondary · POSTED

Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (\>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.

ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.

→

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-herceptin-hylecta-89056784
nct id: NCT00545688
trial label: A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive 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: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0000
source section id
NCT00545688-om-0000
source outcome index
0
endpoint
Percentage of Participants Achieving Pathological Complete Response (pCR)
endpoint definition
pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders
time origin
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population; Analysis was performed according to initial randomization.
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-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0002
source section id
NCT00545688-om-0002
source outcome index
2
endpoint
Percentage of Participants Achieving pCR by Breast Cancer Type
endpoint definition
pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.
time origin
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population; Analysis was performed according to initial randomization. Number (n) equal (=) number of participants included in the specified type of breast cancer.
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-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0003
source section id
NCT00545688-om-0003
source outcome index
3
endpoint
Percentage of Participants Achieving pCR by Hormone Receptor Status
endpoint definition
pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.
time origin
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.
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-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0004
source section id
NCT00545688-om-0004
source outcome index
4
endpoint
Percentage of Participants Achieving pCR by Lymph Node Status
endpoint definition
pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.
time origin
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population; Analysis was performed according to initial randomization.
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-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0005
source section id
NCT00545688-om-0005
source outcome index
5
endpoint
Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS)
endpoint definition
pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.
time origin
Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population; Analysis was performed according to initial randomization.
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-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0001
source section id
NCT00545688-om-0001
source outcome index
1
endpoint
Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography
endpoint definition
Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (\>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.
time origin
Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.
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-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0000
arm key
OG000
arm label
Trastuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0000
arm key
OG001
arm label
Trastuzumab+Pertuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0000
arm key
OG002
arm label
Trastuzumab+Pertuzumab
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0000
arm key
OG003
arm label
Pertuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0001
arm key
OG000
arm label
Trastuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
analyzed count
71
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0001
arm key
OG001
arm label
Trastuzumab+Pertuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0001
arm key
OG002
arm label
Trastuzumab+Pertuzumab
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
analyzed count
61
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0001
arm key
OG003
arm label
Pertuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0002
arm key
OG000
arm label
Trastuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0002
arm key
OG001
arm label
Trastuzumab+Pertuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0002
arm key
OG002
arm label
Trastuzumab+Pertuzumab
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
outcome key
om-0002
arm key
OG003
arm label
Pertuzumab+Docetaxel
regimen
Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
analyzed count
96
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00545688-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT00545688
harm key
EG000
source section id
NCT00545688-ae
event group key
EG000
event group label
Trastuzumab+Docetaxel
serious affected
21
serious at risk
107
other affected
107
other at risk
107
frequency threshold
5
collection period
Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.
event definition
The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.
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-herceptin-hylecta-89056784
nct id
NCT00545688
harm key
EG001
source section id
NCT00545688-ae
event group key
EG001
event group label
Trastuzumab+Pertuzumab+Docetaxel
serious affected
22
serious at risk
107
other affected
105
other at risk
107
frequency threshold
5
collection period
Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.
event definition
The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.
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-herceptin-hylecta-89056784
nct id
NCT00545688
harm key
EG002
source section id
NCT00545688-ae
event group key
EG002
event group label
Trastuzumab+Pertuzumab
serious affected
19
serious at risk
108
other affected
101
other at risk
108
frequency threshold
5
collection period
Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.
event definition
The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.
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-herceptin-hylecta-89056784
nct id
NCT00545688
harm key
EG003
source section id
NCT00545688-ae
event group key
EG003
event group label
Pertuzumab+Docetaxel
serious affected
21
serious at risk
94
other affected
94
other at risk
94
frequency threshold
5
collection period
Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.
event definition
The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.
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