TriangleNCT02437318 · OUTCOME
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA 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
- Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months
What was measured
PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: All subjects with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) 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)
| Group | Source count |
|---|---|
| PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 169 |
| PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 172 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant | 11.0 | Not reported | 7.49 | 14.52 | Not reported |
| PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant | 5.7 | Not reported | 3.65 | 7.36 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.85
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00065
- p Value Comment
- (one-sided)
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.85
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00065
- p Value Comment
- (one-sided)
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.49
- upper Limit
- 14.52
- value
- 11.0
- group Id
- OG001
- lower Limit
- 3.65
- upper Limit
- 7.36
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 169
- group Id
- OG001
- value
- 172
- units
- Participants
- description
- PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- 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
- param Type
- MEDIAN
- population Description
- All subjects with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) who were randomized to study treatment
- reporting Status
- POSTED
- time Frame
- Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months
- title
- Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice