NCT03248492 · OUTCOME
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) · Source last updated 2025-06-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Percent change from baseline
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline up to Week 6, 12, 18, 24, 30, 36 post dose
What was measured
Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.
Analysis population: Best percent change from baseline in sum of diameters 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| 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
Baseline to Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 43 |
|---|
| Part 1: DS-8201a High Dose | 21 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 164 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 167 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -26.2 | 18.3 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -32.9 | 25.4 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -26.9 | 21.6 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -26.9 | 22.5 | Not reported | Not reported | Not reported |
|---|
Baseline to Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 40 |
|---|
| Part 1: DS-8201a High Dose | 21 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 152 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 154 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -39.6 | 22.7 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -43.6 | 28.1 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -39.9 | 24.5 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -40.1 | 24.9 | Not reported | Not reported | Not reported |
|---|
Baseline to Week 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 37 |
|---|
| Part 1: DS-8201a High Dose | 19 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 136 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 138 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -50.1 | 22.1 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -58.5 | 29.4 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -44.4 | 27.8 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -44.9 | 28.0 | Not reported | Not reported | Not reported |
|---|
Baseline to Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 31 |
|---|
| Part 1: DS-8201a High Dose | 17 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 124 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 125 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -56.3 | 22.1 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -61.9 | 32.0 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -49.2 | 30.6 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -49.3 | 30.5 | Not reported | Not reported | Not reported |
|---|
Baseline to Week 30
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 30 |
|---|
| Part 1: DS-8201a High Dose | 15 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 80 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 81 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -59.1 | 26.1 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -63.9 | 32.2 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -51.2 | 29.2 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -51.5 | 29.2 | Not reported | Not reported | Not reported |
|---|
Baseline to Week 36
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 24 |
|---|
| Part 1: DS-8201a High Dose | 9 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 46 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 46 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -61.0 | 26.7 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -54.6 | 32.2 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -55.5 | 29.9 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -55.5 | 29.9 | Not reported | Not reported | Not reported |
|---|
Best percent change from baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: DS-8201a Medium Dose | 43 |
|---|
| Part 1: DS-8201a High Dose | 21 |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | 166 |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | 169 |
|---|
Values in Percent change from baseline · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: DS-8201a Medium Dose | -59.5 | 28.2 | Not reported | Not reported | Not reported |
|---|
| Part 1: DS-8201a High Dose | -65.3 | 27.7 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a: DS-8201a Low Dose | -50.5 | 28.3 | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2a + Part 2b: DS-8201a Low Dose | -50.6 | 28.8 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.3
- value
- -26.2
- group Id
- OG001
- spread
- 25.4
- value
- -32.9
- group Id
- OG002
- spread
- 21.6
- value
- -26.9
- group Id
- OG003
- spread
- 22.5
- value
- -26.9
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 164
- group Id
- OG003
- value
- 167
- units
- Participants
- title
- Baseline to Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 22.7
- value
- -39.6
- group Id
- OG001
- spread
- 28.1
- value
- -43.6
- group Id
- OG002
- spread
- 24.5
- value
- -39.9
- group Id
- OG003
- spread
- 24.9
- value
- -40.1
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 152
- group Id
- OG003
- value
- 154
- units
- Participants
- title
- Baseline to Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 22.1
- value
- -50.1
- group Id
- OG001
- spread
- 29.4
- value
- -58.5
- group Id
- OG002
- spread
- 27.8
- value
- -44.4
- group Id
- OG003
- spread
- 28.0
- value
- -44.9
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 136
- group Id
- OG003
- value
- 138
- units
- Participants
- title
- Baseline to Week 18
- categories
- measurements
- group Id
- OG000
- spread
- 22.1
- value
- -56.3
- group Id
- OG001
- spread
- 32.0
- value
- -61.9
- group Id
- OG002
- spread
- 30.6
- value
- -49.2
- group Id
- OG003
- spread
- 30.5
- value
- -49.3
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 124
- group Id
- OG003
- value
- 125
- units
- Participants
- title
- Baseline to Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 26.1
- value
- -59.1
- group Id
- OG001
- spread
- 32.2
- value
- -63.9
- group Id
- OG002
- spread
- 29.2
- value
- -51.2
- group Id
- OG003
- spread
- 29.2
- value
- -51.5
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 80
- group Id
- OG003
- value
- 81
- units
- Participants
- title
- Baseline to Week 30
- categories
- measurements
- group Id
- OG000
- spread
- 26.7
- value
- -61.0
- group Id
- OG001
- spread
- 32.2
- value
- -54.6
- group Id
- OG002
- spread
- 29.9
- value
- -55.5
- group Id
- OG003
- spread
- 29.9
- value
- -55.5
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 46
- units
- Participants
- title
- Baseline to Week 36
- categories
- measurements
- group Id
- OG000
- spread
- 28.2
- value
- -59.5
- group Id
- OG001
- spread
- 27.7
- value
- -65.3
- group Id
- OG002
- spread
- 28.3
- value
- -50.5
- group Id
- OG003
- spread
- 28.8
- value
- -50.6
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 166
- group Id
- OG003
- value
- 169
- units
- Participants
- title
- Best percent change from baseline
- 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
- Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Best percent change from baseline in sum of diameters was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
- reporting Status
- POSTED
- time Frame
- Baseline up to Week 6, 12, 18, 24, 30, 36 post dose
- title
- Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
- type
- SECONDARY
- unit Of Measure
- Percent change from baseline
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