TriangleNCT04639219 · OUTCOME
Disease Control Rate (DCR) as Per RECIST v1.1 Using ICR and Investigator 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
- Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
What was measured
DCR at 6 weeks was defined as the percentage of participants who had the best objective response (BoR) of confirmed CR or PR, or who had stable disease (SD) (without subsequent cancer therapy), for at least 5 weeks after first dose of study treatment. DCR at 12 weeks was defined as the percentage of patients who had the BoR of confirmed CR or PR, or who had SD (without subsequent cancer therapy), for at least 11 weeks after first dose of study treatment. CR was defined as disappearance of all TL and PR was defined as at least a 30% decrease in sum of the dms of TL, taking as reference the baseline sum of dms as long as criteria for PD were not met. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (\>=20% increase in sum of dms of TLs and an absolute increase of \>=5 millimeters, taking as reference smallest sum of dms since treatment started including baseline sum of dms). CI was calculated using Clopper-Pearson method.
Analysis population: The FAS consisted of all participants who received at least 1 dose of study treatment.
Groups in this outcome
T-DXd
Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
| Group | Source count |
|---|---|
| T-DXd | 102 |
Reported measurements
DCR at 6 weeks by ICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 75.5 | Not reported | 66.0 | 83.5 | Not reported |
DCR at 6 weeks by Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 70.6 | Not reported | 60.7 | 79.2 | Not reported |
DCR at 12 weeks by ICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 53.9 | Not reported | 43.8 | 63.8 | Not reported |
DCR at 12 weeks by Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 55.9 | Not reported | 45.7 | 65.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 66.0
- upper Limit
- 83.5
- value
- 75.5
- title
- DCR at 6 weeks by ICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 60.7
- upper Limit
- 79.2
- value
- 70.6
- title
- DCR at 6 weeks by Investigator assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43.8
- upper Limit
- 63.8
- value
- 53.9
- title
- DCR at 12 weeks by ICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.7
- upper Limit
- 65.7
- value
- 55.9
- title
- DCR at 12 weeks by Investigator assessment
- denoms
- counts
- group Id
- OG000
- value
- 102
- units
- Participants
- description
- DCR at 6 weeks was defined as the percentage of participants who had the best objective response (BoR) of confirmed CR or PR, or who had stable disease (SD) (without subsequent cancer therapy), for at least 5 weeks after first dose of study treatment. DCR at 12 weeks was defined as the percentage of patients who had the BoR of confirmed CR or PR, or who had SD (without subsequent cancer therapy), for at least 11 weeks after first dose of study treatment. CR was defined as disappearance of all TL and PR was defined as at least a 30% decrease in sum of the dms of TL, taking as reference the baseline sum of dms as long as criteria for PD were not met. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (\>=20% increase in sum of dms of TLs and an absolute increase of \>=5 millimeters, taking as reference smallest sum of dms since treatment started including baseline sum of dms). CI was calculated using Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants harboring tumors with specific HER2 activating mutations received T-DXd 5.4 mg/kg via IV infusion on Day 1 of each cycle (21 days), every 3 weeks until RECIST v1.1-defined PD, withdrawal of consent, or until any other of the discontinuation criteria was met.
- id
- OG000
- title
- T-DXd
- param Type
- NUMBER
- population Description
- The FAS consisted of all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Tumor scans performed at screening, then q6w +/- 1 week relative to the date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months)
- title
- Disease Control Rate (DCR) as Per RECIST v1.1 Using ICR and Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice