Participant flow

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.

groups

1. description

   Subjects 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

   FG000

   title

   Alpelisib + Fulvestrant

2. description

   Subjects 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

   FG001

   title

   Placebo + Fulvestrant

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         207

      2. group Id

         FG001

         num Subjects

         240

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         11

      type

      Subject/guardian decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         22

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         4

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         7

      type

      Protocol deviation

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Sponsor decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         284

      2. group Id

         FG001

         num Subjects

         288

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         284

      2. group Id

         FG001

         num Subjects

         287

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         169

      2. group Id

         FG001

         num Subjects

         172

      comment

      Subjects with advanced breast cancer with a PIK3CA mutation based on central testing of hotspot-mutations in tumor tissue

      type

      PIK3CA Mutant Cohort by Tumor Tissue

   4. achievements

      1. group Id

         FG000

         num Subjects

         115

      2. group Id

         FG001

         num Subjects

         116

      comment

      Subjects with advanced breast cancer without a PIK3CA mutation based on central testing of hotspot-mutations in tumor tissue

      type

      PIK3CA Non-mutant Cohort by Tumor Tissue

   5. achievements

      1. group Id

         FG000

         num Subjects

         92

      2. group Id

         FG001

         num Subjects

         94

      comment

      Subjects with advanced breast cancer with a PIK3CA mutation measured in ctDNA

      type

      PIK3CA Mutant Cohort by ctDNA

   6. achievements

      1. group Id

         FG000

         num Subjects

         181

      2. group Id

         FG001

         num Subjects

         182

      comment

      Subjects with advanced breast cancer without a PIK3CA mutation measured in ctDNA

      type

      PIK3CA Non-mutant Cohort by ctDNA

   7. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         284

      2. group Id

         FG001

         num Subjects

         288

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

One subject in the PIK3CA mutant cohort, who was randomized to the placebo + fulvestrant arm, did not receive study treatment due to a protocol deviation.

recruitment Details

Participants were enrolled in 198 centers across 31 countries

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

Preserved source evidence · Not medical advice