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NCT02437318 · OUTCOME

Trough Plasma Concentration of Alpelisib

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
GEOMETRIC_MEAN
Unit
nanogram (ng)/ milliliter (mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days

What was measured

Pre-dose plasma concentrations of alpelisib were assessed. Only participants randomized to the alpelisib + fulvestrant arm were included in this analysis.

Analysis population: Participants who received at least one dose of alpelisib and provided at least one evaluable trough plasma concentration for alpelisib at the specified time points

Groups in this outcome

Alpelisib + Fulvestrant

Subjects with advanced breast cancer with or without a PIK3CA mutation 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)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant96

Reported measurements

Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant96
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant42441.1Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant64
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant46857.6Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant92
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant43653.4Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant61
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant45869.4Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant44
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant41857.1Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant36
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant46958.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.1
        value
        424
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      units
      Participants
    title
    Cycle 1 Day 8
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.6
        value
        468
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.4
        value
        436
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    Cycle 2 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.4
        value
        458
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Cycle 4 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.1
        value
        418
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Cycle 6 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.3
        value
        469
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Cycle 8 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    units
    Participants
description
Pre-dose plasma concentrations of alpelisib were assessed. Only participants randomized to the alpelisib + fulvestrant arm were included in this analysis.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Subjects with advanced breast cancer with or without a PIK3CA mutation 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
    Alpelisib + Fulvestrant
param Type
GEOMETRIC_MEAN
population Description
Participants who received at least one dose of alpelisib and provided at least one evaluable trough plasma concentration for alpelisib at the specified time points
reporting Status
POSTED
time Frame
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days
title
Trough Plasma Concentration of Alpelisib
type
SECONDARY
unit Of Measure
nanogram (ng)/ milliliter (mL)

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Preserved source evidence · Not medical advice