TriangleNCT03734029 · OUTCOME
Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
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
- From the date of randomization up to the date of death due to any cause, up to approximately 3 years
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 was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
Analysis population: Overall survival (OS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.
Groups in this outcome
Trastuzumab Deruxtecan (T-DXd)
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
Physician's Choice
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
| Group | Source count |
|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 331 |
| Physician's Choice | 163 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab Deruxtecan (T-DXd) | 23.9 | Not reported | 20.8 | 24.8 | Not reported |
| Physician's Choice | 17.5 | Not reported | 15.2 | 22.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.8
- upper Limit
- 24.8
- value
- 23.9
- group Id
- OG001
- lower Limit
- 15.2
- upper Limit
- 22.4
- value
- 17.5
- denoms
- counts
- group Id
- OG000
- value
- 331
- group Id
- OG001
- value
- 163
- 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 was no death reported for a participant before the data cutoff for OS analysis, OS was censored at the last contact date at which the participant was known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
- id
- OG000
- title
- Trastuzumab Deruxtecan (T-DXd)
- description
- Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.
- id
- OG001
- title
- Physician's Choice
- param Type
- MEDIAN
- population Description
- Overall survival (OS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.
- reporting Status
- POSTED
- time Frame
- From the date of randomization up to the date of death due to any cause, up to approximately 3 years
- title
- Overall Survival (OS) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice