TriangleNCT02437318 · OUTCOME
OS in the PIK3CA Non-mutant Cohort
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 56.4 months
What was measured
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using Kaplan-Meier methodology.
Analysis population: All subjects without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment
Groups in this outcome
PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant
Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
| Group | Source count |
|---|---|
| PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 115 |
| PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 116 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 37.29 | Not reported | 27.89 | 45.47 | Not reported |
| PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 34.30 | Not reported | 26.81 | 39.03 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.89
- upper Limit
- 45.47
- value
- 37.29
- group Id
- OG001
- lower Limit
- 26.81
- upper Limit
- 39.03
- value
- 34.30
- denoms
- counts
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 116
- units
- Participants
- description
- OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using Kaplan-Meier methodology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
- id
- OG000
- title
- PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant
- description
- Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
- id
- OG001
- title
- PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
- param Type
- MEDIAN
- population Description
- All subjects without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment
- reporting Status
- POSTED
- time Frame
- Up to 56.4 months
- title
- OS in the PIK3CA Non-mutant Cohort
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice