TriangleNCT05113251 · OUTCOME
Rate of Pathologic Complete Response (pCR).
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
- Not reported
- Time frame
- Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)
What was measured
Proportion of participants who have no evidence by Hematoxylin \& Eosin (H\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.
Analysis population: Full analysis set
Groups in this outcome
Arm A
Trastuzumab deruxtecan (5.4 mg/kg Q3W for 8 cycles)
Arm B
Trastuzumab deruxtecan (5.4 mg/kg Q3W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles
Arm C
Doxorubicin (60 mg/m2 Q2W) and cyclophosphamide (600 mg/m2 Q2W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles
| Group | Source count |
|---|---|
| Arm A | 286 |
| Arm B | 321 |
| Arm C | 320 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A | 43.01 | Not reported | Not reported | Not reported | Not reported |
| Arm B | 67.29 | Not reported | Not reported | Not reported | Not reported |
| Arm C | 56.25 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -20.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -5.41
- estimate Comment
- A difference in rates \> 0 favours T-DXd to be associated with a higher rate of pCR than ddAC-THP.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.001
- param Type
- M&N estimate of difference in rates
- param Value
- -13.18
- statistical Comment
- Stratified by HR status and HER2 status, with strata weighting by sample size (i.e. Mantel-Haenszel weights).
- statistical Method
- Miettinen and Nurminen's (M&N) method
- ci Lower Limit
- 3.95
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.28
- estimate Comment
- A difference in rates \> 0 favours T-DXd-THP to be associated with a higher rate of pCR than ddAC-THP.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.003
- param Type
- M&N estimate of difference in rates
- param Value
- 11.17
- statistical Comment
- Stratified by HR status and HER2 status, with strata weighting by sample size (i.e. Mantel-Haenszel weights).
- statistical Method
- Miettinen and Nurminen's (M&N) method
Complete source fields
- analyses
- ci Lower Limit
- -20.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -5.41
- estimate Comment
- A difference in rates \> 0 favours T-DXd to be associated with a higher rate of pCR than ddAC-THP.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.001
- param Type
- M&N estimate of difference in rates
- param Value
- -13.18
- statistical Comment
- Stratified by HR status and HER2 status, with strata weighting by sample size (i.e. Mantel-Haenszel weights).
- statistical Method
- Miettinen and Nurminen's (M&N) method
- ci Lower Limit
- 3.95
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.28
- estimate Comment
- A difference in rates \> 0 favours T-DXd-THP to be associated with a higher rate of pCR than ddAC-THP.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.003
- param Type
- M&N estimate of difference in rates
- param Value
- 11.17
- statistical Comment
- Stratified by HR status and HER2 status, with strata weighting by sample size (i.e. Mantel-Haenszel weights).
- statistical Method
- Miettinen and Nurminen's (M&N) method
- classes
- categories
- measurements
- group Id
- OG000
- value
- 43.01
- group Id
- OG001
- value
- 67.29
- group Id
- OG002
- value
- 56.25
- denoms
- counts
- group Id
- OG000
- value
- 286
- group Id
- OG001
- value
- 321
- group Id
- OG002
- value
- 320
- units
- Participants
- description
- Proportion of participants who have no evidence by Hematoxylin \& Eosin (H\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.
- groups
- description
- Trastuzumab deruxtecan (5.4 mg/kg Q3W for 8 cycles)
- id
- OG000
- title
- Arm A
- description
- Trastuzumab deruxtecan (5.4 mg/kg Q3W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles
- id
- OG001
- title
- Arm B
- description
- Doxorubicin (60 mg/m2 Q2W) and cyclophosphamide (600 mg/m2 Q2W) for 4 cycles, followed by Paclitaxel (80 mg/m2 QW on Days 1, 8, and 15) + trastuzumab (8 mg/kg loading dose followed by 6 mg/kg Q3W on Day 1) + pertuzumab (840 mg loading dose followed by 420 mg Q3W on Day 1) for 4 cycles
- id
- OG002
- title
- Arm C
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025)
- title
- Rate of Pathologic Complete Response (pCR).
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice