TriangleNCT04494425 · OUTCOME
Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat 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
PFS2 was defined as time from randomization to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death; second progression was defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. Median PFS2 was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Analysis population: The HER2-low population included subset of participants in ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per IRT data for HER2 IHC expression. The ITT population included all randomized participants. 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
HER2-low Population
| Group | Source count |
|---|---|
| T-DXd | 359 |
| Chemotherapy | 354 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 20.0 | Not reported | 18.9 | 23.8 | Not reported |
| Chemotherapy | 14.5 | Not reported | 12.9 | 15.5 | Not reported |
ITT Population
| Group | Source count |
|---|---|
| T-DXd | 436 |
| Chemotherapy | 430 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 20.3 | Not reported | 18.9 | 23.8 | Not reported |
| Chemotherapy | 14.7 | Not reported | 13.5 | 15.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.9
- upper Limit
- 23.8
- value
- 20.0
- group Id
- OG001
- lower Limit
- 12.9
- upper Limit
- 15.5
- value
- 14.5
- denoms
- counts
- group Id
- OG000
- value
- 359
- group Id
- OG001
- value
- 354
- units
- Participants
- title
- HER2-low Population
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.9
- upper Limit
- 23.8
- value
- 20.3
- group Id
- OG001
- lower Limit
- 13.5
- upper Limit
- 15.9
- value
- 14.7
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- title
- ITT Population
- denoms
- counts
- group Id
- OG000
- value
- 436
- group Id
- OG001
- value
- 430
- units
- Participants
- description
- PFS2 was defined as time from randomization to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death; second progression was defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. Median PFS2 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
- The HER2-low population included subset of participants in ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per IRT data for HER2 IHC expression. The ITT population included all randomized participants. 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
- Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice