TriangleNCT03529110 · OUTCOME
Progression-Free Survival (PFS) Based on 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
Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Analysis population: Progression-free survival (PFS) 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 25.1 | Not reported | 22.1 | NA | Upper CI was not estimable due to insufficient number of events. |
| Ado-trastuzumab Emtansine (T-DM1) | 7.2 | Not reported | 6.8 | 8.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper CI was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- NA
- value
- 25.1
- group Id
- OG001
- lower Limit
- 6.8
- upper Limit
- 8.3
- value
- 7.2
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 263
- units
- Participants
- description
- Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
- 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
- Progression-free survival (PFS) 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
- Progression-Free Survival (PFS) Based on 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
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice