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NCT02437318 · OUTCOME

Trough Plasma Concentration of Fulvestrant

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 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 fulvestrant were assessed.

Analysis population: Participants who received at least one dose of fulvestrant and provided at least one evaluable trough plasma concentration for fulvestrant 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)

Placebo + Fulvestrant

Subjects with advanced breast cancer with or without a PIK3CA mutation 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
Alpelisib + Fulvestrant124
Placebo + Fulvestrant124

Reported measurements

Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant106
Placebo + Fulvestrant124
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant10.843.5Not reportedNot reportedNot reported
Placebo + Fulvestrant10.351.0Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant89
Placebo + Fulvestrant98
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant14.039.7Not reportedNot reportedNot reported
Placebo + Fulvestrant14.741.2Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant91
Placebo + Fulvestrant74
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant11.532.2Not reportedNot reportedNot reported
Placebo + Fulvestrant12.229.8Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant124
Placebo + Fulvestrant98
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant12.630.5Not reportedNot reportedNot reported
Placebo + Fulvestrant14.024.2Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Alpelisib + Fulvestrant52
Placebo + Fulvestrant55
Values in nanogram (ng)/ milliliter (mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alpelisib + Fulvestrant13.535.2Not reportedNot reportedNot reported
Placebo + Fulvestrant14.723.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.5
        value
        10.8
      2. group Id
        OG001
        spread
        51.0
        value
        10.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        124
      units
      Participants
    title
    Cycle 1 Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.7
        value
        14.0
      2. group Id
        OG001
        spread
        41.2
        value
        14.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        98
      units
      Participants
    title
    Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        32.2
        value
        11.5
      2. group Id
        OG001
        spread
        29.8
        value
        12.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.5
        value
        12.6
      2. group Id
        OG001
        spread
        24.2
        value
        14.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        124
      2. group Id
        OG001
        value
        98
      units
      Participants
    title
    Cycle 6 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.2
        value
        13.5
      2. group Id
        OG001
        spread
        23.2
        value
        14.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        55
      units
      Participants
    title
    Cycle 8 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      124
    units
    Participants
description
Pre-dose plasma concentrations of fulvestrant were assessed.
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
  2. description
    Subjects with advanced breast cancer with or without a PIK3CA mutation 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
    Placebo + Fulvestrant
param Type
GEOMETRIC_MEAN
population Description
Participants who received at least one dose of fulvestrant and provided at least one evaluable trough plasma concentration for fulvestrant at the specified time points
reporting Status
POSTED
time Frame
Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days
title
Trough Plasma Concentration of Fulvestrant
type
SECONDARY
unit Of Measure
nanogram (ng)/ milliliter (mL)

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Preserved source evidence · Not medical advice