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← Herceptin Hylecta: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy

NCT01358877 · STUDY IN CONTEXT

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

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

secondary · POSTED

The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.

The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.

→

secondary · POSTED

Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

ITT population

→

secondary · POSTED

Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).

ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years.

→

secondary · POSTED

Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.

The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.

→

secondary · POSTED

Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.

ITT population

→

secondary · POSTED

Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.

ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years.

→

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

EORTC QLQ · Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0023
source section id
NCT01358877-om-0023
source outcome index
23
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
measure definition
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
time frame
Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0024
source section id
NCT01358877-om-0024
source outcome index
24
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
measure definition
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0025
source section id
NCT01358877-om-0025
source outcome index
25
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
measure definition
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0026
source section id
NCT01358877-om-0026
source outcome index
26
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
measure definition
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0027
source section id
NCT01358877-om-0027
source outcome index
27
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
measure definition
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0028
source section id
NCT01358877-om-0028
source outcome index
28
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
measure definition
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0029
source section id
NCT01358877-om-0029
source outcome index
29
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
measure definition
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0030
source section id
NCT01358877-om-0030
source outcome index
30
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
measure definition
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0031
source section id
NCT01358877-om-0031
source outcome index
31
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
measure definition
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0032
source section id
NCT01358877-om-0032
source outcome index
32
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
measure definition
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-herceptin-hylecta-89056784
nct id
NCT01358877
qol key
qol-0033
source section id
NCT01358877-om-0033
source outcome index
33
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
measure definition
EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
time frame
Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
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
NCT01358877
trial label
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
applicability
unclear
applicability note
Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
11
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0000
    source section id
    NCT01358877-om-0000
    source outcome index
    0
    endpoint
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    endpoint definition
    The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
    time origin
    6, 8, and 10 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0001
    source section id
    NCT01358877-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    endpoint definition
    Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
    time origin
    Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0002
    source section id
    NCT01358877-om-0002
    source outcome index
    2
    endpoint
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    endpoint definition
    Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0003
    source section id
    NCT01358877-om-0003
    source outcome index
    3
    endpoint
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    endpoint definition
    Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
    time origin
    6, 8, and 10 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0004
    source section id
    NCT01358877-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    endpoint definition
    Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
    time origin
    Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0005
    source section id
    NCT01358877-om-0005
    source outcome index
    5
    endpoint
    Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    endpoint definition
    Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
    time origin
    3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pertuzumab + Trastuzumab + Chemotherapy
    regimen
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    analyzed count
    2400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + Trastuzumab + Chemotherapy
    regimen
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    analyzed count
    2404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pertuzumab + Trastuzumab + Chemotherapy
    regimen
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    analyzed count
    2400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + Trastuzumab + Chemotherapy
    regimen
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    analyzed count
    2404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pertuzumab + Trastuzumab + Chemotherapy
    regimen
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    analyzed count
    2093
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + Trastuzumab + Chemotherapy
    regimen
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    analyzed count
    2095
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pertuzumab + Trastuzumab + Chemotherapy
    regimen
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    analyzed count
    2400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + Trastuzumab + Chemotherapy
    regimen
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    analyzed count
    2404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pertuzumab + Trastuzumab + Chemotherapy
    regimen
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    analyzed count
    2400
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + Trastuzumab + Chemotherapy
    regimen
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    analyzed count
    2404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pertuzumab + Trastuzumab + Chemotherapy
    regimen
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    analyzed count
    2091
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + Trastuzumab + Chemotherapy
    regimen
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    analyzed count
    2090
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01358877-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    harm key
    EG000
    source section id
    NCT01358877-ae
    event group key
    EG000
    event group label
    Pertuzumab + Trastuzumab + Chemotherapy
    serious affected
    792
    serious at risk
    2364
    other affected
    2353
    other at risk
    2364
    frequency threshold
    5
    collection period
    From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years)
    event definition
    All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    harm key
    EG001
    source section id
    NCT01358877-ae
    event group key
    EG001
    event group label
    Placebo + Trastuzumab + Chemotherapy
    serious affected
    686
    serious at risk
    2405
    other affected
    2374
    other at risk
    2405
    frequency threshold
    5
    collection period
    From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years)
    event definition
    All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0023
    source section id
    NCT01358877-om-0023
    source outcome index
    23
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
    measure definition
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
    time frame
    Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0024
    source section id
    NCT01358877-om-0024
    source outcome index
    24
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
    measure definition
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0025
    source section id
    NCT01358877-om-0025
    source outcome index
    25
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
    measure definition
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0026
    source section id
    NCT01358877-om-0026
    source outcome index
    26
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
    measure definition
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0027
    source section id
    NCT01358877-om-0027
    source outcome index
    27
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
    measure definition
    EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0028
    source section id
    NCT01358877-om-0028
    source outcome index
    28
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
    measure definition
    EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0029
    source section id
    NCT01358877-om-0029
    source outcome index
    29
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
    measure definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0030
    source section id
    NCT01358877-om-0030
    source outcome index
    30
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
    measure definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0031
    source section id
    NCT01358877-om-0031
    source outcome index
    31
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
    measure definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0032
    source section id
    NCT01358877-om-0032
    source outcome index
    32
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
    measure definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-89056784
    nct id
    NCT01358877
    qol key
    qol-0033
    source section id
    NCT01358877-om-0033
    source outcome index
    33
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
    measure definition
    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems \[scored as 1\], some or moderate problems \[scored as 2\], and extreme problems \[scored as 3\]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.
    time frame
    Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice