Participant flow

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.

groups

1. description

   Participants received inavolisib, 9 milligrams (mg), orally, once daily (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, intramuscular (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

   FG000

   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

   FG001

   title

   Pbo+Palbo+Fulv

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         55

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Progressive Disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Symptomatic Deterioration

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   8. reasons

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         97

      type

      Ongoing in the study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         161

      2. group Id

         FG001

         num Subjects

         164

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         161

      2. group Id

         FG001

         num Subjects

         164

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 325 participants with phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit, alpha isoform (PIK3CA) mutation, hormone receptor-positive, human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer were randomized in 1:1 ratio to Inavolisib+ Palbociclib + Fulvestrant (Inavo+Palbo+Fulv) arm or Placebo + Palbociclib + Fulvestrant (Pbo+Palbo+Fulv) arm in this study.

recruitment Details

Participants took part in the study across 123 investigative centers in 28 countries. This study is still ongoing.

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Preserved source evidence · Not medical advice