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NCT02437318 · OUTCOME

PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline

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
From baseline up to 56.4 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. Subjects were analyzed according to the PIK3CA mutation status (mutant or non-mutant) as identified using plasma ctDNA. 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: Subjects who were randomized to study treatment with an evaluable mutation status by ctDNA at baseline

Groups in this outcome

PIK3CA Mutant Determined by ctDNA: Alpelisib + Fulvestrant

Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Placebo + Fulvestrant

Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Alpelisib + Fulvestrant

Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Placebo + Fulvestrant

Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Alpelisib + Fulvestrant92
PIK3CA Mutant Determined by ctDNA: Placebo + Fulvestrant94
PIK3CA Non-mutant Determined by ctDNA: Alpelisib + Fulvestrant181
PIK3CA Non-mutant Determined by ctDNA: Placebo + Fulvestrant182

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PIK3CA Mutant Determined by ctDNA: Alpelisib + Fulvestrant10.9Not reported7.0315.28Not reported
PIK3CA Mutant Determined by ctDNA: Placebo + Fulvestrant3.7Not reported2.276.11Not reported
PIK3CA Non-mutant Determined by ctDNA: Alpelisib + Fulvestrant9.0Not reported7.2311.01Not reported
PIK3CA Non-mutant Determined by ctDNA: Placebo + Fulvestrant7.4Not reported5.559.20Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.03
        upper Limit
        15.28
        value
        10.9
      2. group Id
        OG001
        lower Limit
        2.27
        upper Limit
        6.11
        value
        3.7
      3. group Id
        OG002
        lower Limit
        7.23
        upper Limit
        11.01
        value
        9.0
      4. group Id
        OG003
        lower Limit
        5.55
        upper Limit
        9.20
        value
        7.4
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      94
    3. group Id
      OG002
      value
      181
    4. group Id
      OG003
      value
      182
    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. Subjects were analyzed according to the PIK3CA mutation status (mutant or non-mutant) as identified using plasma ctDNA. 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 (measured in ctDNA) 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 Determined by ctDNA: Alpelisib + Fulvestrant
  2. description
    Subjects with advanced breast cancer with a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Placebo + Fulvestrant
  3. description
    Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Alpelisib + Fulvestrant
  4. description
    Subjects with advanced breast cancer without a PIK3CA mutation (measured in ctDNA) 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 Determined by ctDNA: Placebo + Fulvestrant
param Type
MEDIAN
population Description
Subjects who were randomized to study treatment with an evaluable mutation status by ctDNA at baseline
reporting Status
POSTED
time Frame
From baseline up to 56.4 months
title
PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice