Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03778931 · OUTCOME

Overall Survival in ESR1-mut Participants

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

What was measured

Overall survival in ESR1-mut participants, where overall survival is defined as the length of time from randomization until the date of death from any cause.

Groups in this outcome

Elacestrant

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

Standard of Care (SoC)

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

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

Analysis denominator · Participants

GroupSource count
Elacestrant115
Standard of Care (SoC)113

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ElacestrantNANot reported18.60NANA=not calculable (insufficient number of participants with events)
Standard of Care (SoC)16.95Not reported14.00NANA=not calculable (insufficient number of participants with events)

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.361
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.958
    group Description
    The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0325
    p Value Comment
    The p-value was generated by using a two-sided stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.592
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.361
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.958
    group Description
    The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0325
    p Value Comment
    The p-value was generated by using a two-sided stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.592
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA=not calculable (insufficient number of participants with events)
        group Id
        OG000
        lower Limit
        18.60
        upper Limit
        NA
        value
        NA
      2. comment
        NA=not calculable (insufficient number of participants with events)
        group Id
        OG001
        lower Limit
        14.00
        upper Limit
        NA
        value
        16.95
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    2. group Id
      OG001
      value
      113
    units
    Participants
description
Overall survival in ESR1-mut participants, where overall survival is defined as the length of time from randomization until the date of death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing
    id
    OG000
    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
    OG001
    title
    Standard of Care (SoC)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
title
Overall Survival in ESR1-mut Participants
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice