TriangleNCT00829166 · OUTCOME
Time to Symptom Progression
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
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.
Analysis population: 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.
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 | 450 |
| Lapatinib + Capecitabine | 445 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Emtansine | 7.1 | Not reported | 5.59 | 8.44 | Not reported |
| Lapatinib + Capecitabine | 4.6 | Not reported | 4.14 | 5.78 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.667
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.951
- 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
- 0.0121
- param Type
- Hazard Ratio (HR)
- param Value
- 0.796
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.667
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.951
- 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
- 0.0121
- param Type
- Hazard Ratio (HR)
- param Value
- 0.796
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.59
- upper Limit
- 8.44
- value
- 7.1
- group Id
- OG001
- lower Limit
- 4.14
- upper Limit
- 5.78
- value
- 4.6
- denoms
- counts
- group Id
- OG000
- value
- 450
- group Id
- OG001
- value
- 445
- units
- Participants
- description
- 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.
- 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. Only female participants with a Baseline assessment and at least 1 follow-up assessment 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
- Time to Symptom Progression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice