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NCT04191499 · OUTCOME

Plasma Concentration of Inavolisib

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer · Source last updated 2026-06-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
nanogram/milliliter (ng/ml)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)

Analysis population: Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Groups in this outcome

Inavo+Palbo+Fulv

Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.

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

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv151

Reported measurements

Predose, Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv151
Values in nanogram/milliliter (ng/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+FulvNANANot reportedNot reportedThe data was not estimable as the samples were below the lower limit of quantification (BLLQ).
3 hours Post-dose, Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv151
Values in nanogram/milliliter (ng/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv36223Not reportedNot reportedNot reported
Predose, Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv121
Values in nanogram/milliliter (ng/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv17.8134Not reportedNot reportedNot reported
Predose, Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv117
Values in nanogram/milliliter (ng/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv13.6240Not reportedNot reportedNot reported
3 hours Post-dose, Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv120
Values in nanogram/milliliter (ng/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv59.2119Not reportedNot reportedNot reported
Predose, Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv115
Values in nanogram/milliliter (ng/ml) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv16.9124Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The data was not estimable as the samples were below the lower limit of quantification (BLLQ).
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      units
      Participants
    title
    Predose, Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        223
        value
        36
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      units
      Participants
    title
    3 hours Post-dose, Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        134
        value
        17.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      units
      Participants
    title
    Predose, Cycle 1 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        240
        value
        13.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      units
      Participants
    title
    Predose, Cycle 1 Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        119
        value
        59.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      units
      Participants
    title
    3 hours Post-dose, Cycle 1 Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        124
        value
        16.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      units
      Participants
    title
    Predose, Cycle 2 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
    id
    OG000
    title
    Inavo+Palbo+Fulv
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
reporting Status
POSTED
time Frame
Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days)
title
Plasma Concentration of Inavolisib
type
SECONDARY
unit Of Measure
nanogram/milliliter (ng/ml)

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Preserved source evidence · Not medical advice