Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04191499 · OUTCOME

Plasma Concentration of Palbociclib

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
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: 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.

Pbo+Palbo+Fulv

Participants received placebo, 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 of 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+Fulv154
Pbo+Palbo+Fulv153

Reported measurements

Predose, Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv154
Pbo+Palbo+Fulv153
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+FulvNANANot reportedNot reportedThe data was not estimable as the samples were BLLQ.
Pbo+Palbo+FulvNANANot reportedNot reportedThe data was not estimable as the samples were BLLQ.
3 hours Post-dose, Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv154
Pbo+Palbo+Fulv153
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv20.7182Not reportedNot reportedNot reported
Pbo+Palbo+Fulv22.9251Not reportedNot reportedNot reported
Predose, Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv134
Pbo+Palbo+Fulv138
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv73.956Not reportedNot reportedNot reported
Pbo+Palbo+Fulv74.550Not reportedNot reportedNot reported
Predose, Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv136
Pbo+Palbo+Fulv134
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv69.978Not reportedNot reportedNot reported
Pbo+Palbo+Fulv73.365Not reportedNot reportedNot reported
3 hours Post-dose, Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv138
Pbo+Palbo+Fulv131
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv96.755Not reportedNot reportedNot reported
Pbo+Palbo+Fulv98.062Not reportedNot reportedNot reported
Predose, Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Inavo+Palbo+Fulv130
Pbo+Palbo+Fulv122
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Inavo+Palbo+Fulv58.5111Not reportedNot reportedNot reported
Pbo+Palbo+Fulv66.990Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The data was not estimable as the samples were BLLQ.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        The data was not estimable as the samples were BLLQ.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        153
      units
      Participants
    title
    Predose, Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        182
        value
        20.7
      2. group Id
        OG001
        spread
        251
        value
        22.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        153
      units
      Participants
    title
    3 hours Post-dose, Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        56
        value
        73.9
      2. group Id
        OG001
        spread
        50
        value
        74.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        134
      2. group Id
        OG001
        value
        138
      units
      Participants
    title
    Predose, Cycle 1 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        78
        value
        69.9
      2. group Id
        OG001
        spread
        65
        value
        73.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        136
      2. group Id
        OG001
        value
        134
      units
      Participants
    title
    Predose, Cycle 1 Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        55
        value
        96.7
      2. group Id
        OG001
        spread
        62
        value
        98.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    3 hours Post-dose, Cycle 1 Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        111
        value
        58.5
      2. group Id
        OG001
        spread
        90
        value
        66.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Predose, Cycle 2 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      153
    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
  2. description
    Participants received placebo, 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 of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination.
    id
    OG001
    title
    Pbo+Palbo+Fulv
param Type
GEOMETRIC_MEAN
population Description
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 Palbociclib
type
SECONDARY
unit Of Measure
ng/ml

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

Preserved source evidence · Not medical advice