TriangleNCT01120184 · OUTCOME
Percentage of Participants With Objective Response According to IRF Assessment
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
- Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
What was measured
Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate \[ORR\]) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
Analysis population: ITT Population. Only participants with measurable disease at Baseline were included in the analysis.
Groups in this outcome
Trastuzumab + Taxane
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
Trastuzumab Emtansine + Placebo
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
Trastuzumab Emtansine + Pertuzumab
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
| Group | Source count |
|---|---|
| Trastuzumab + Taxane | 287 |
| Trastuzumab Emtansine + Placebo | 303 |
| Trastuzumab Emtansine + Pertuzumab | 299 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab + Taxane | 67.9 | Not reported | 62.26 | 73.31 | Not reported |
| Trastuzumab Emtansine + Placebo | 59.7 | Not reported | 54.07 | 65.30 | Not reported |
| Trastuzumab Emtansine + Pertuzumab | 64.2 | Not reported | 58.62 | 69.65 | Not reported |
Source statistical analyses
- ci Lower Limit
- -15.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.5
- estimate Comment
- Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rate
- param Value
- -8.2
- ci Lower Limit
- -11.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.9
- estimate Comment
- Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rate
- param Value
- -3.7
- ci Lower Limit
- -3.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.2
- estimate Comment
- Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rate
- param Value
- 4.5
Complete source fields
- analyses
- ci Lower Limit
- -15.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.5
- estimate Comment
- Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rate
- param Value
- -8.2
- ci Lower Limit
- -11.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.9
- estimate Comment
- Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rate
- param Value
- -3.7
- ci Lower Limit
- -3.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.2
- estimate Comment
- Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Difference in Response Rate
- param Value
- 4.5
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.26
- upper Limit
- 73.31
- value
- 67.9
- group Id
- OG001
- lower Limit
- 54.07
- upper Limit
- 65.30
- value
- 59.7
- group Id
- OG002
- lower Limit
- 58.62
- upper Limit
- 69.65
- value
- 64.2
- denoms
- counts
- group Id
- OG000
- value
- 287
- group Id
- OG001
- value
- 303
- group Id
- OG002
- value
- 299
- units
- Participants
- description
- Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate \[ORR\]) was calculated as \[number of participants meeting the respective criteria divided by the number analyzed\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
- id
- OG000
- title
- Trastuzumab + Taxane
- description
- Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
- id
- OG001
- title
- Trastuzumab Emtansine + Placebo
- description
- Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
- id
- OG002
- title
- Trastuzumab Emtansine + Pertuzumab
- param Type
- NUMBER
- population Description
- ITT Population. Only participants with measurable disease at Baseline were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
- title
- Percentage of Participants With Objective Response According to IRF Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice