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NCT02437318 · OUTCOME

Overall Survival (OS) in the PIK3CA Mutant Cohort

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. · Source last updated 2025-02-13

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 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 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 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant169
PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant172

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant39.3Not reported34.1044.85Not reported
PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant31.4Not reported26.7841.30Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.10
        upper Limit
        44.85
        value
        39.3
      2. group Id
        OG001
        lower Limit
        26.78
        upper Limit
        41.30
        value
        31.4
denoms
  1. counts
    1. group Id
      OG000
      value
      169
    2. group Id
      OG001
      value
      172
    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
  1. 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
  2. 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 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 months
title
Overall Survival (OS) in the PIK3CA Mutant Cohort
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice