TriangleNCT04494425 · OUTCOME
Duration of Response (DOR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, 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
- Inter-Quartile Range
- 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
DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. 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 DOR was calculated using Kaplan-Meier method.
Analysis population: The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression. Only participants with response in each specified category 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 | 217 |
| Chemotherapy | 143 |
Reported measurements
BICR Assessment
| Group | Source count |
|---|---|
| T-DXd | 217 |
| Chemotherapy | 134 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 13.6 | Not reported | 6.2 | 24.9 | Not reported |
| Chemotherapy | 7.3 | Not reported | 4.2 | 15.2 | Not reported |
Investigator Assessment
| Group | Source count |
|---|---|
| T-DXd | 217 |
| Chemotherapy | 143 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 12.0 | Not reported | 6.6 | 20.0 | Not reported |
| Chemotherapy | 6.9 | Not reported | 3.1 | 11.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.2
- upper Limit
- 24.9
- value
- 13.6
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- 15.2
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 217
- group Id
- OG001
- value
- 134
- units
- Participants
- title
- BICR Assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.6
- upper Limit
- 20.0
- value
- 12.0
- group Id
- OG001
- lower Limit
- 3.1
- upper Limit
- 11.1
- value
- 6.9
- denoms
- counts
- group Id
- OG000
- value
- 217
- group Id
- OG001
- value
- 143
- units
- Participants
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 217
- group Id
- OG001
- value
- 143
- units
- Participants
- description
- DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. 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 DOR was calculated using Kaplan-Meier method.
- dispersion Type
- Inter-Quartile Range
- 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 the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression. Only participants with response in each specified category 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
- Duration of Response (DOR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice