TriangleNCT03523585 · OUTCOME
Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
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
- Baseline up to 46 months postdose
What was measured
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.
Analysis population: Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.
Groups in this outcome
Trastuzumab Deruxtecan (T-DXd)
Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Treatment of Investigator's/Physician's Choice (TPC)
Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 406 |
| Treatment of Investigator's/Physician's Choice (TPC) | 202 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 39.2 | Not reported | 32.7 | NA | Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events. |
| Treatment of Investigator's/Physician's Choice (TPC) | 26.5 | Not reported | 21.0 | NA | Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events. |
Source statistical analyses
- ci Lower Limit
- 0.5023
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.8605
- estimate Comment
- Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0021
- p Value Comment
- Stratified Log-rank p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.6575
- statistical Comment
- p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.5023
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.8605
- estimate Comment
- Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0021
- p Value Comment
- Stratified Log-rank p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.6575
- statistical Comment
- p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 32.7
- upper Limit
- NA
- value
- 39.2
- comment
- Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 21.0
- upper Limit
- NA
- value
- 26.5
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 202
- units
- Participants
- description
- Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), 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 standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.
- id
- OG001
- title
- Treatment of Investigator's/Physician's Choice (TPC)
- param Type
- MEDIAN
- population Description
- Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.
- reporting Status
- POSTED
- time Frame
- Baseline up to 46 months postdose
- title
- Overall Survival (OS) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice