TriangleNCT02437318 · OUTCOME
Time to 10% Deterioration in the Global Health Status (GHS) /Quality of Life (QOL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
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 55.7 months
What was measured
The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as at least 10% relative to baseline worsening of the GHS/QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.
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 | 18.14 | Not reported | 14.55 | 28.68 | Not reported |
| PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 19.98 | Not reported | 11.50 | 25.59 | Not reported |
| PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 7.39 | Not reported | 5.62 | NA | NA: not estimable due to the insufficient number of participants with events |
| PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 9.23 | Not reported | 3.94 | 13.17 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.55
- upper Limit
- 28.68
- value
- 18.14
- group Id
- OG001
- lower Limit
- 11.50
- upper Limit
- 25.59
- value
- 19.98
- comment
- NA: not estimable due to the insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 5.62
- upper Limit
- NA
- value
- 7.39
- group Id
- OG003
- lower Limit
- 3.94
- upper Limit
- 13.17
- value
- 9.23
- 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
- The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as at least 10% relative to baseline worsening of the GHS/QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.
- 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 55.7 months
- title
- Time to 10% Deterioration in the Global Health Status (GHS) /Quality of Life (QOL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice