TriangleNCT00829166 · STUDY IN CONTEXT
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic 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
PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (\>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.
Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: \>/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.
OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.
The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.
OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.
Reported safety
Quality of life and patient-reported measures
FACT · Percentage of Participants With Symptom Progression
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- qol key
- qol-0015
- source section id
- NCT00829166-om-0015
- source outcome index
- 15
- instrument
- FACT
- instrument basis
- matched 'fact-b' in the study's own wording
- scale title
- Percentage of Participants With Symptom Progression
- measure definition
- Symptom progression was defined as the documentation of a \>/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale \[BCS\]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported.
- time frame
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicating better
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Time to Symptom Progression
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- qol key
- qol-0016
- source section id
- NCT00829166-om-0016
- source outcome index
- 16
- instrument
- FACT
- instrument basis
- matched 'fact-b' in the study's own wording
- scale title
- Time to Symptom Progression
- measure definition
- Time to symptom progression was defined as the time from randomization to the first documentation of a \>/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.
- time frame
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicating better
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- trial label
- A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0000
- source section id
- NCT00829166-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
- endpoint definition
- PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (\>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.
- time origin
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0001
- source section id
- NCT00829166-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)
- endpoint definition
- Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: \>/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
- time origin
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0002
- source section id
- NCT00829166-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Died: Second Interim Analysis
- endpoint definition
- The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.
- time origin
- From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0003
- source section id
- NCT00829166-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival: Second Interim Analysis (Co-primary Endpoint)
- endpoint definition
- OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.
- time origin
- From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0004
- source section id
- NCT00829166-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants Who Died: Final Analysis
- endpoint definition
- The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.
- time origin
- From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0005
- source section id
- NCT00829166-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival: Final Analysis
- endpoint definition
- OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.
- time origin
- From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Trastuzumab Emtansine
- regimen
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Lapatinib + Capecitabine
- regimen
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- analyzed count
- 496
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Trastuzumab Emtansine
- regimen
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Lapatinib + Capecitabine
- regimen
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- analyzed count
- 496
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Trastuzumab Emtansine
- regimen
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Lapatinib + Capecitabine
- regimen
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- analyzed count
- 496
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Trastuzumab Emtansine
- regimen
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Lapatinib + Capecitabine
- regimen
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- analyzed count
- 496
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Trastuzumab Emtansine
- regimen
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Lapatinib + Capecitabine
- regimen
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- analyzed count
- 496
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Trastuzumab Emtansine
- regimen
- Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
- analyzed count
- 495
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Lapatinib + Capecitabine
- regimen
- Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
- analyzed count
- 496
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00829166-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- harm key
- EG000
- source section id
- NCT00829166-ae
- event group key
- EG000
- event group label
- Trastuzumab Emtansine
- serious affected
- 92
- serious at risk
- 490
- other affected
- 474
- other at risk
- 490
- frequency threshold
- 5
- collection period
- Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).
- event definition
- Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- harm key
- EG001
- source section id
- NCT00829166-ae
- event group key
- EG001
- event group label
- Lapatinib + Capecitabine
- serious affected
- 99
- serious at risk
- 488
- other affected
- 471
- other at risk
- 488
- frequency threshold
- 5
- collection period
- Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).
- event definition
- Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- harm key
- EG002
- source section id
- NCT00829166-ae
- event group key
- EG002
- event group label
- Lapatinib + Capecitabine/ Trastuzumab Emtansine
- serious affected
- 19
- serious at risk
- 136
- other affected
- 115
- other at risk
- 136
- frequency threshold
- 5
- collection period
- Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).
- event definition
- Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- qol key
- qol-0015
- source section id
- NCT00829166-om-0015
- source outcome index
- 15
- instrument
- FACT
- instrument basis
- matched 'fact-b' in the study's own wording
- scale title
- Percentage of Participants With Symptom Progression
- measure definition
- Symptom progression was defined as the documentation of a \>/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale \[BCS\]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported.
- time frame
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicating better
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-verzenio-728af395
- nct id
- NCT00829166
- qol key
- qol-0016
- source section id
- NCT00829166-om-0016
- source outcome index
- 16
- instrument
- FACT
- instrument basis
- matched 'fact-b' in the study's own wording
- scale title
- Time to Symptom Progression
- measure definition
- Time to symptom progression was defined as the time from randomization to the first documentation of a \>/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much"). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.
- time frame
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicating better
- population note
- ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.
- 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