TriangleNCT03529110 · OUTCOME
Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
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
- 95% Confidence Interval
- Time frame
- Up to 33 months (data cut-off)
What was measured
The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
Analysis population: Objective response rate was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
Groups in this outcome
Trastuzumab Deruxtecan (T-DXd)
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Ado-trastuzumab Emtansine (T-DM1)
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 261 |
| Ado-trastuzumab Emtansine (T-DM1) | 263 |
Reported measurements
BICR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 79.7 | Not reported | 74.3 | 84.4 | Not reported |
| Ado-trastuzumab Emtansine (T-DM1) | 34.2 | Not reported | 28.5 | 40.3 | Not reported |
Investigator Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 77.0 | Not reported | 71.2 | 82.0 | Not reported |
| Ado-trastuzumab Emtansine (T-DM1) | 36.9 | Not reported | 31.0 | 43.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.3
- upper Limit
- 84.4
- value
- 79.7
- group Id
- OG001
- lower Limit
- 28.5
- upper Limit
- 40.3
- value
- 34.2
- title
- BICR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.2
- upper Limit
- 82.0
- value
- 77.0
- group Id
- OG001
- lower Limit
- 31.0
- upper Limit
- 43.0
- value
- 36.9
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- OG000
- title
- Trastuzumab Deruxtecan (T-DXd)
- description
- Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
- id
- OG001
- title
- Ado-trastuzumab Emtansine (T-DM1)
- param Type
- NUMBER
- population Description
- Objective response rate was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
- reporting Status
- POSTED
- time Frame
- Up to 33 months (data cut-off)
- title
- Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice