TriangleNCT00829166 · OUTCOME
Percentage of Participants With Clinical Benefit as Assessed by an IRC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
What was measured
Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments \>/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: \>/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: \>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.
Analysis population: ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.
Groups in this outcome
Trastuzumab Emtansine
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.
Lapatinib + Capecitabine
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.
| Group | Source count |
|---|---|
| Trastuzumab Emtansine | 397 |
| Lapatinib + Capecitabine | 389 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine | 58.2 | Not reported | 53.3 | 63.1 | Not reported |
| Lapatinib + Capecitabine | 44.2 | Not reported | 39.2 | 49.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 7.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.9
- estimate Comment
- The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Difference in Clinical Benefit Rate
- param Value
- 14
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 7.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.9
- estimate Comment
- The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Difference in Clinical Benefit Rate
- param Value
- 14
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.3
- upper Limit
- 63.1
- value
- 58.2
- group Id
- OG001
- lower Limit
- 39.2
- upper Limit
- 49.2
- value
- 44.2
- denoms
- counts
- group Id
- OG000
- value
- 397
- group Id
- OG001
- value
- 389
- units
- Participants
- description
- Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments \>/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: \>/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: \>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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.
- id
- OG000
- title
- Trastuzumab Emtansine
- description
- 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.
- id
- OG001
- title
- Lapatinib + Capecitabine
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
- title
- Percentage of Participants With Clinical Benefit as Assessed by an IRC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice