Participant flow

Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer · Source last updated 2025-09-15

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

groups

1. description

   Participants in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing

   id

   FG000

   title

   Elacestrant

2. description

   Participants in Arm 2 will receive Investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: * Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle * Anastrozole 1 mg/day on a continuous dosing schedule * Letrozole: 2.5 mg/day on a continuous dosing schedule * Exemestane: 25 mg/day on a continuous dosing schedule

   id

   FG001

   title

   Standard of Care (SoC)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         25

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant Noncompliance

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         79

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         239

      2. group Id

         FG001

         num Subjects

         239

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         239

      2. group Id

         FG001

         num Subjects

         239

      type

      Intent-to-Treat Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         237

      2. group Id

         FG001

         num Subjects

         230

      type

      Safety Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         152

      2. comment

         Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section.

         group Id

         FG001

         num Subjects

         130

      comment

      Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section.

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         87

      2. group Id

         FG001

         num Subjects

         109

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice