TriangleNCT03523585 · OUTCOME
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) 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
Progression-free survival (PFS) by BICR was defined as the time from the date of randomization 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.
Analysis population: Progression-free survival (PFS) 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) | 17.8 | Not reported | 14.3 | 20.8 | Not reported |
| Treatment of Investigator's/Physician's Choice (TPC) | 6.9 | Not reported | 5.5 | 8.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.2840
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.4535
- 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
- <0.000001
- p Value Comment
- Stratified Log-rank p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.3589
- 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
- 0.2840
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.4535
- 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
- <0.000001
- p Value Comment
- Stratified Log-rank p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.3589
- 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
- group Id
- OG000
- lower Limit
- 14.3
- upper Limit
- 20.8
- value
- 17.8
- group Id
- OG001
- lower Limit
- 5.5
- upper Limit
- 8.4
- value
- 6.9
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 202
- units
- Participants
- description
- Progression-free survival (PFS) by BICR was defined as the time from the date of randomization 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.
- 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
- Progression-free survival (PFS) 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
- Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice