Skip to content
Triangle logo TriangleGet started
← Herceptin Hylecta: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy

NCT01419197 · STUDY IN CONTEXT

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens o

Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic disease. 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

Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.

Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.

→

primary · POSTED

Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.

Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.

Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.

Randomized population: All participants who were randomized to the study. Only participants with an objective response were included in the analysis. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.

Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.

Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.

→

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 · Time to Pain Symptom Progression

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-6ea26642
nct id
NCT01419197
qol key
qol-0005
source section id
NCT01419197-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Pain Symptom Progression
measure definition
Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.
time frame
Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.
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 the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle

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-6ea26642
nct id
NCT01419197
qol key
qol-0006
source section id
NCT01419197-om-0006
source outcome index
6
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle
measure definition
The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.
time frame
Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.
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-6ea26642
nct id
NCT01419197
trial label
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens o
applicability
unclear
applicability note
Attached because the study's own record names HER2 and describes metastatic disease. 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
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0000
    source section id
    NCT01419197-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival
    endpoint definition
    Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.
    time origin
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0001
    source section id
    NCT01419197-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.
    time origin
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0002
    source section id
    NCT01419197-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With an Objective Response
    endpoint definition
    An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.
    time origin
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0003
    source section id
    NCT01419197-om-0003
    source outcome index
    3
    endpoint
    Duration of the Objective Response
    endpoint definition
    Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.
    time origin
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Only participants with an objective response were included in the analysis. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0004
    source section id
    NCT01419197-om-0004
    source outcome index
    4
    endpoint
    6-month and 1-year Survival
    endpoint definition
    6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.
    time origin
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0005
    source section id
    NCT01419197-om-0005
    source outcome index
    5
    endpoint
    Time to Pain Symptom Progression
    endpoint definition
    Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.
    time origin
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Trastuzumab Emtansine
    regimen
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    analyzed count
    404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Treatment of Physician's Choice
    regimen
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    analyzed count
    198
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Trastuzumab Emtansine
    regimen
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    analyzed count
    404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Treatment of Physician's Choice
    regimen
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    analyzed count
    198
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Trastuzumab Emtansine
    regimen
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    analyzed count
    345
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Treatment of Physician's Choice
    regimen
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    analyzed count
    163
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Trastuzumab Emtansine
    regimen
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Treatment of Physician's Choice
    regimen
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Trastuzumab Emtansine
    regimen
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    analyzed count
    404
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Treatment of Physician's Choice
    regimen
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    analyzed count
    198
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Trastuzumab Emtansine
    regimen
    Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
    analyzed count
    297
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Treatment of Physician's Choice
    regimen
    Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01419197-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01419197
    harm key
    EG000
    source section id
    NCT01419197-ae
    event group key
    EG000
    event group label
    Trastuzumab Emtansine
    serious affected
    102
    serious at risk
    403
    other affected
    371
    other at risk
    403
    frequency threshold
    5
    collection period
    Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).
    event definition
    Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).
    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-6ea26642
    nct id
    NCT01419197
    harm key
    EG001
    source section id
    NCT01419197-ae
    event group key
    EG001
    event group label
    Treatment of Physician's Choice (TPC)
    serious affected
    41
    serious at risk
    184
    other affected
    148
    other at risk
    184
    frequency threshold
    5
    collection period
    Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).
    event definition
    Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).
    undenominated note
    Source null
    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-6ea26642
    nct id
    NCT01419197
    harm key
    EG002
    source section id
    NCT01419197-ae
    event group key
    EG002
    event group label
    Trastuzumab Emtansine - Post TPC Treatment Switch
    serious affected
    19
    serious at risk
    94
    other affected
    74
    other at risk
    94
    frequency threshold
    5
    collection period
    Adverse events were collected from treatment initiation until 30 days following the last administration of study drug or study discontinuation on 31 August 2015 (up to approximately 4 years).
    event definition
    Safety population: All participants who received any amount of planned study treatment, according to treatment actually received. Data for participants in the Treatment of Physicians Choice (TPC) arm who switched treatment to receive trastuzumab emtansine (TE) following disease progression on TPC are presented separately. Median treatment duration of trastuzumab emtansine: 5.2 months (range 0.03-40.7),TPC: 2.7 months (range 0.03-31.0) and TE - Post TPC Treatment Switch: 4.5 months (range 1-43).
    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-6ea26642
    nct id
    NCT01419197
    qol key
    qol-0005
    source section id
    NCT01419197-om-0005
    source outcome index
    5
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Pain Symptom Progression
    measure definition
    Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.
    time frame
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.
    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-6ea26642
    nct id
    NCT01419197
    qol key
    qol-0006
    source section id
    NCT01419197-om-0006
    source outcome index
    6
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle
    measure definition
    The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.
    time frame
    Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.
    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