TriangleNCT02437318 · OUTCOME
Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline
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 baseline up to 56.4 months
What was measured
ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration of ECOG PS by one score was defined as the time from the date of randomization to the date of the event, defined as experiencing at least one score lower than the baseline. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.
Analysis population: All subjects who were randomized to study treatment
Groups in this outcome
PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant
Subjects with advanced breast cancer with 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 Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
Subjects with advanced breast cancer with 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)
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 Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 169 |
| PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 172 |
| 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 Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 34.07 | Not reported | 26.32 | NA | NA: Not estimable due to the insufficient number of participants with events |
| PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | NA | Not reported | 22.11 | NA | NA: Not estimable due to the insufficient number of participants with events |
| PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | NA | Not reported | 13.83 | NA | NA: Not estimable due to the insufficient number of participants with events |
| PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 40.44 | Not reported | 18.46 | 47.21 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA: Not estimable due to the insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 26.32
- upper Limit
- NA
- value
- 34.07
- comment
- NA: Not estimable due to the insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 22.11
- upper Limit
- NA
- value
- NA
- comment
- NA: Not estimable due to the insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 13.83
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 18.46
- upper Limit
- 47.21
- value
- 40.44
- denoms
- counts
- group Id
- OG000
- value
- 169
- group Id
- OG001
- value
- 172
- group Id
- OG002
- value
- 115
- group Id
- OG003
- value
- 116
- units
- Participants
- description
- ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration of ECOG PS by one score was defined as the time from the date of randomization to the date of the event, defined as experiencing at least one score lower than the baseline. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects with advanced breast cancer with 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 Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant
- description
- Subjects with advanced breast cancer with 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 Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
- 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
- OG002
- 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
- OG003
- title
- PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant
- param Type
- MEDIAN
- population Description
- All subjects who were randomized to study treatment
- reporting Status
- POSTED
- time Frame
- From baseline up to 56.4 months
- title
- Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice