TriangleNCT00829166 · OUTCOME
PFS as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- 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 the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the 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. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.
Analysis population: ITT population included all randomized participants on the basis of the treatment assigned at randomization.
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 | 495 |
| Lapatinib + Capecitabine | 496 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine | 9.4 | Not reported | 7.49 | 10.78 | Not reported |
| Lapatinib + Capecitabine | 5.8 | Not reported | 5.59 | 6.93 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.560
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.774
- estimate Comment
- HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.
- group Description
- Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.658
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.560
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.774
- estimate Comment
- HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.
- group Description
- Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.658
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.49
- upper Limit
- 10.78
- value
- 9.4
- group Id
- OG001
- lower Limit
- 5.59
- upper Limit
- 6.93
- value
- 5.8
- denoms
- counts
- group Id
- OG000
- value
- 495
- group Id
- OG001
- value
- 496
- units
- Participants
- description
- Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as \>/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the 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. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.
- 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
- MEDIAN
- population Description
- ITT population included all randomized participants on the basis of the treatment assigned at randomization.
- 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
- PFS as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice