A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants 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

Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.

Safety population included all participants who were randomized and received study drug.

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primary · POSTED

Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.

Safety population included all participants who were randomized and received study drug.

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secondary · POSTED

pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.

Intent to treat (ITT) population included all participants who were randomized to treatment.

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secondary · POSTED

Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions.

ITT population included all participants who were randomized to treatment.

→

secondary · POSTED

Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions.

ITT population included all participants who were randomized to treatment.

→

secondary · POSTED

This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.

Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.

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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-6ea26642
nct id: NCT00976989
trial label: A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants 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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0000
source section id
NCT00976989-om-0000
source outcome index
0
endpoint
Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
endpoint definition
Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.
time origin
From baseline up to approximately 3.5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety population included all participants who were randomized and received study drug.
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-6ea26642
nct id
NCT00976989
outcome key
om-0001
source section id
NCT00976989-om-0001
source outcome index
1
endpoint
Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
endpoint definition
Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.
time origin
From baseline up to approximately 18 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety population included all participants who were randomized and received study drug.
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-6ea26642
nct id
NCT00976989
outcome key
om-0002
source section id
NCT00976989-om-0002
source outcome index
2
endpoint
Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
endpoint definition
pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.
time origin
At surgery, after 18 weeks (6 cycles) of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat (ITT) population included all participants who were randomized to treatment.
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-6ea26642
nct id
NCT00976989
outcome key
om-0003
source section id
NCT00976989-om-0003
source outcome index
3
endpoint
Efficacy: Clinical Response Rate
endpoint definition
Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions.
time origin
During each 3-week cycle of 6 total cycles: up to 18 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who were randomized to treatment.
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-6ea26642
nct id
NCT00976989
outcome key
om-0004
source section id
NCT00976989-om-0004
source outcome index
4
endpoint
Efficacy: Time to Clinical Response
endpoint definition
Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions.
time origin
Up to 18 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who were randomized to treatment.
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-6ea26642
nct id
NCT00976989
outcome key
om-0005
source section id
NCT00976989-om-0005
source outcome index
5
endpoint
Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
endpoint definition
This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.
time origin
At approximately 18 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.
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-6ea26642
nct id
NCT00976989
outcome key
om-0000
arm key
OG000
arm label
T+P Concomitant Anthracycline-based Chemotherapy
regimen
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0000
arm key
OG001
arm label
T+P Sequential Anthracycline-based Chemotherapy
regimen
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
analyzed count
75
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0000
arm key
OG002
arm label
T+P Concomitant Non-Anthracycline Chemotherapy
regimen
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
76
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0001
arm key
OG000
arm label
T+P Concomitant Anthracycline-based Chemotherapy
regimen
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0001
arm key
OG001
arm label
T+P Sequential Anthracycline-based Chemotherapy
regimen
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
analyzed count
75
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0001
arm key
OG002
arm label
T+P Concomitant Non-Anthracycline Chemotherapy
regimen
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
76
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0002
arm key
OG000
arm label
T+P Concomitant Anthracycline-based Chemotherapy
regimen
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
73
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0002
arm key
OG001
arm label
T+P Sequential Anthracycline-based Chemotherapy
regimen
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
analyzed count
75
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0002
arm key
OG002
arm label
T+P Concomitant Non-Anthracycline Chemotherapy
regimen
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
77
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0003
arm key
OG000
arm label
T+P Concomitant Anthracycline-based Chemotherapy
regimen
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
73
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0003
arm key
OG001
arm label
T+P Sequential Anthracycline-based Chemotherapy
regimen
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
analyzed count
75
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
outcome key
om-0003
arm key
OG002
arm label
T+P Concomitant Non-Anthracycline Chemotherapy
regimen
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
analyzed count
77
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00976989-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-6ea26642
nct id
NCT00976989
harm key
EG000
source section id
NCT00976989-ae
event group key
EG000
event group label
T+P Concomitant Anthracycline-based Chemotherapy
serious affected
23
serious at risk
72
other affected
72
other at risk
72
frequency threshold
5
collection period
Up to approximately 5 years
event definition
Safety population included all participants who were randomized and received study drug.
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-6ea26642
nct id
NCT00976989
harm key
EG001
source section id
NCT00976989-ae
event group key
EG001
event group label
T+P Sequential Anthracycline-based Chemotherapy
serious affected
18
serious at risk
75
other affected
73
other at risk
75
frequency threshold
5
collection period
Up to approximately 5 years
event definition
Safety population included all participants who were randomized and received study drug.
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-6ea26642
nct id
NCT00976989
harm key
EG002
source section id
NCT00976989-ae
event group key
EG002
event group label
T+P Concomitant Non-Anthracycline Chemotherapy
serious affected
31
serious at risk
76
other affected
76
other at risk
76
frequency threshold
5
collection period
Up to approximately 5 years
event definition
Safety population included all participants who were randomized and received study drug.
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