TriangleNCT03529110 · OUTCOME
Duration of Response (DoR) 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
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 33 months (data cut-off)
What was measured
Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.
Analysis population: Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR 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 | Source count |
|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 208 |
| Ado-trastuzumab Emtansine (T-DM1) | 90 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | NA | Not reported | 20.3 | NA | Median and upper CI was not estimable due insufficient number of events. |
| Ado-trastuzumab Emtansine (T-DM1) | NA | Not reported | 12.6 | NA | Median and upper CI was not estimable due insufficient number of events. |
Investigator Assessment
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 201 |
| Ado-trastuzumab Emtansine (T-DM1) | 97 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | NA | Not reported | 20.8 | NA | Median and upper CI was not estimable due insufficient number of events. |
| Ado-trastuzumab Emtansine (T-DM1) | NA | Not reported | 14.1 | NA | Median and upper CI was not estimable due insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper CI was not estimable due insufficient number of events.
- group Id
- OG000
- lower Limit
- 20.3
- upper Limit
- NA
- value
- NA
- comment
- Median and upper CI was not estimable due insufficient number of events.
- group Id
- OG001
- lower Limit
- 12.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 90
- units
- Participants
- title
- BICR
- categories
- measurements
- comment
- Median and upper CI was not estimable due insufficient number of events.
- group Id
- OG000
- lower Limit
- 20.8
- upper Limit
- NA
- value
- NA
- comment
- Median and upper CI was not estimable due insufficient number of events.
- group Id
- OG001
- lower Limit
- 14.1
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 97
- units
- Participants
- title
- Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment 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
- MEDIAN
- population Description
- Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 21 May 2021.
- reporting Status
- POSTED
- time Frame
- Up to 33 months (data cut-off)
- title
- Duration of Response (DoR) 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
- months
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Preserved source evidence · Not medical advice