TriangleNCT03248492 · OUTCOME
Disease Control Rate and Clinical Benefit Rate 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
What was measured
Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.
Analysis population: Disease control rate (DCR) and clinical benefit rate (CBR) were 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 | 48 |
| Part 1: DS-8201a High Dose | 21 |
| Part 1 + Part 2a: DS-8201a Low Dose | 180 |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 184 |
Reported measurements
Disease control rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: DS-8201a Medium Dose | 47 | Not reported | Not reported | Not reported | Not reported |
| Part 1: DS-8201a High Dose | 21 | Not reported | Not reported | Not reported | Not reported |
| Part 1 + Part 2a: DS-8201a Low Dose | 175 | Not reported | Not reported | Not reported | Not reported |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 179 | Not reported | Not reported | Not reported | Not reported |
Clinical benefit rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: DS-8201a Medium Dose | 41 | Not reported | Not reported | Not reported | Not reported |
| Part 1: DS-8201a High Dose | 20 | Not reported | Not reported | Not reported | Not reported |
| Part 1 + Part 2a: DS-8201a Low Dose | 127 | Not reported | Not reported | Not reported | Not reported |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 130 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 175
- group Id
- OG003
- value
- 179
- title
- Disease control rate
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 127
- group Id
- OG003
- value
- 130
- title
- Clinical benefit rate
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 180
- group Id
- OG003
- value
- 184
- units
- Participants
- description
- Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Disease control rate (DCR) and clinical benefit rate (CBR) were 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
- Disease Control Rate and Clinical Benefit Rate 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
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice