TriangleNCT03248492 · OUTCOME
Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
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
- at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
What was measured
The estimated duration of confirmed response (complete response \[CR\] or partial response \[PR\]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.
Analysis population: Participants with CR or PR were analyzed. Estimated duration of response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Groups in this outcome
Part 1: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 1: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 1 + Part 2a: DS-8201a Low Dose
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
| Group | Source count |
|---|---|
| Part 1: DS-8201a Medium Dose | 33 |
| Part 1: DS-8201a High Dose | 17 |
| Part 1 + Part 2a: DS-8201a Low Dose | 109 |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 111 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: DS-8201a Medium Dose | NA | Not reported | 8.3 | NA | There were not enough events to estimate a standard error for the median survival time. |
| Part 1: DS-8201a High Dose | 6.0 | Not reported | 4.8 | 8.3 | Not reported |
| Part 1 + Part 2a: DS-8201a Low Dose | NA | Not reported | NA | NA | Lack of a median value is due to less than 50% of the participants experiencing the event. |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | NA | Not reported | NA | NA | Lack of a median value is due to less than 50% of the participants experiencing the event. |
Complete source fields
- classes
- categories
- measurements
- comment
- There were not enough events to estimate a standard error for the median survival time.
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 4.8
- upper Limit
- 8.3
- value
- 6.0
- comment
- Lack of a median value is due to less than 50% of the participants experiencing the event.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Lack of a median value is due to less than 50% of the participants experiencing the event.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 109
- group Id
- OG003
- value
- 111
- units
- Participants
- description
- The estimated duration of confirmed response (complete response \[CR\] or partial response \[PR\]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
- id
- OG000
- title
- Part 1: DS-8201a Medium Dose
- description
- T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
- id
- OG001
- title
- Part 1: DS-8201a High Dose
- description
- All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
- id
- OG002
- title
- Part 1 + Part 2a: DS-8201a Low Dose
- description
- All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
- id
- OG003
- title
- Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
- param Type
- MEDIAN
- population Description
- Participants with CR or PR were analyzed. Estimated duration of response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
- reporting Status
- POSTED
- time Frame
- at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
- title
- Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice