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NCT02437318 · OUTCOME

Updated PFS Per Investigator Assessment in the PIK3CA Mutant Cohort (Longer Follow-up)

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
Up to 55.7 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. This analysis was conducted at the time of the final OS analysis (when approximately 178 deaths in the PIK3CA mutant cohort had been achieved) and includes a longer follow-up time. 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 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 + Fulvestrant10.97Not reported7.4914.52Not reported
PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant5.65Not reported3.657.36Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.49
        upper Limit
        14.52
        value
        10.97
      2. group Id
        OG001
        lower Limit
        3.65
        upper Limit
        7.36
        value
        5.65
denoms
  1. counts
    1. group Id
      OG000
      value
      169
    2. 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. This analysis was conducted at the time of the final OS analysis (when approximately 178 deaths in the PIK3CA mutant cohort had been achieved) and includes a longer follow-up time. 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
  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 who were randomized to study treatment
reporting Status
POSTED
time Frame
Up to 55.7 months
title
Updated PFS Per Investigator Assessment in the PIK3CA Mutant Cohort (Longer Follow-up)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Months

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

Preserved source evidence · Not medical advice