TriangleNCT04494425 · OUTCOME
Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
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 date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
What was measured
OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Analysis population: The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression.
Groups in this outcome
T-DXd
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
Chemotherapy
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
| Group | Source count |
|---|---|
| T-DXd | 359 |
| Chemotherapy | 354 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| T-DXd | 28.9 | Not reported | 25.7 | 33.7 | Not reported |
| Chemotherapy | 27.1 | Not reported | 23.5 | 29.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.7
- upper Limit
- 33.7
- value
- 28.9
- group Id
- OG001
- lower Limit
- 23.5
- upper Limit
- 29.9
- value
- 27.1
- denoms
- counts
- group Id
- OG000
- value
- 359
- group Id
- OG001
- value
- 354
- units
- Participants
- description
- OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
- id
- OG000
- title
- T-DXd
- description
- Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression.
- reporting Status
- POSTED
- time Frame
- From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
- title
- Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice