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NCT04975308 · OUTCOME

Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B)

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer · Source last updated 2026-07-22

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
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)

What was measured

PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).

Analysis population: All participants who were randomly assigned to either arm A or arm B (including censored). Number of participants censored in "Arm A=171," "Arm B=171."

Groups in this outcome

Arm A: Imlunestrant

Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.

Arm B: Investigator's Choice of Endocrine Therapy

Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.

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

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant331
Arm B: Investigator's Choice of Endocrine Therapy330

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Imlunestrant9.23Not reported7.3311.07Not reported
Arm B: Investigator's Choice of Endocrine Therapy7.36Not reported5.559.40Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.33
        upper Limit
        11.07
        value
        9.23
      2. group Id
        OG001
        lower Limit
        5.55
        upper Limit
        9.40
        value
        7.36
denoms
  1. counts
    1. group Id
      OG000
      value
      331
    2. group Id
      OG001
      value
      330
    units
    Participants
description
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
    id
    OG000
    title
    Arm A: Imlunestrant
  2. description
    Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
    id
    OG001
    title
    Arm B: Investigator's Choice of Endocrine Therapy
param Type
MEDIAN
population Description
All participants who were randomly assigned to either arm A or arm B (including censored). Number of participants censored in "Arm A=171," "Arm B=171."
reporting Status
POSTED
time Frame
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
title
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice