TriangleNCT03248492 · OUTCOME
Objective Response Rate as Confirmed By the Investigator 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
The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.
Analysis population: Objective response rate (ORR) was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Groups in this outcome
Part 1 and Part 2a: DS-8201a Low Dose
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
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.
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.
| Group | Source count |
|---|---|
| Part 1 and Part 2a: DS-8201a Low Dose | 180 |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 184 |
| Part 1: DS-8201a Medium Dose | 48 |
| Part 1: DS-8201a High Dose | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 and Part 2a: DS-8201a Low Dose | 116 | Not reported | Not reported | Not reported | Not reported |
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 118 | Not reported | Not reported | Not reported | Not reported |
| Part 1: DS-8201a Medium Dose | 37 | Not reported | Not reported | Not reported | Not reported |
| Part 1: DS-8201a High Dose | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 118
- group Id
- OG002
- value
- 37
- group Id
- OG003
- value
- 18
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 184
- group Id
- OG002
- value
- 48
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.
- groups
- description
- All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
- id
- OG000
- title
- Part 1 and 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
- OG001
- title
- Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
- 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
- OG002
- 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
- OG003
- title
- Part 1: DS-8201a High Dose
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Objective response rate (ORR) 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
- Objective Response Rate as Confirmed By the Investigator 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