TriangleNCT04494425 · OUTCOME
Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population
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
- Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
What was measured
PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Analysis population: ITT population: all randomized participants. HER2 IHC \>0 \<1+ population: subset of participants included in ITT population with HER2 IHC \>0 \<1+ as determined by central laboratory testing and who have had at least 24 weeks of follow-up at time of interim futility PCD. HER2-low population: subset of participants in ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per IRT data for HER2 IHC expression. Only participants with data collected in specified categories are reported.
Groups in this outcome
T-DXd
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
Chemotherapy
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
| Group | Source count |
|---|---|
| T-DXd | 436 |
| Chemotherapy | 430 |
Reported measurements
ITT Population
| Group | Source count |
|---|---|
| T-DXd | 436 |
| Chemotherapy | 430 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 13.2 | Not reported | 12.0 | 15.2 | Not reported |
| Chemotherapy | 8.1 | Not reported | 7.0 | 9.0 | Not reported |
HER2 IHC >0 <1+ Population
| Group | Source count |
|---|---|
| T-DXd | 76 |
| Chemotherapy | 76 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 13.2 | Not reported | 9.8 | 17.3 | Not reported |
| Chemotherapy | 8.3 | Not reported | 5.8 | 15.2 | Not reported |
HER2-low Population
| Group | Source count |
|---|---|
| T-DXd | 359 |
| Chemotherapy | 354 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 12.8 | Not reported | 11.1 | 13.2 | Not reported |
| Chemotherapy | 7.0 | Not reported | 6.4 | 7.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 15.2
- value
- 13.2
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 9.0
- value
- 8.1
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- title
- ITT Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.8
- upper Limit
- 17.3
- value
- 13.2
- group Id
- OG001
- lower Limit
- 5.8
- upper Limit
- 15.2
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 76
- units
- Participants
- title
- HER2 IHC >0 <1+ Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- 13.2
- value
- 12.8
- group Id
- OG001
- lower Limit
- 6.4
- upper Limit
- 7.5
- value
- 7.0
- denoms
- counts
- group Id
- OG000
- value
- 359
- group Id
- OG001
- value
- 354
- units
- Participants
- title
- HER2-low Population
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- description
- PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
- id
- OG000
- title
- T-DXd
- description
- Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- ITT population: all randomized participants. HER2 IHC \>0 \<1+ population: subset of participants included in ITT population with HER2 IHC \>0 \<1+ as determined by central laboratory testing and who have had at least 24 weeks of follow-up at time of interim futility PCD. HER2-low population: subset of participants in ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per IRT data for HER2 IHC expression. Only participants with data collected in specified categories are reported.
- reporting Status
- POSTED
- time Frame
- Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
- title
- Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice