Giredestrant / Giredestrant-matched Placebo / Letrozole · Phase 3 Trial

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 randomized controlled trial comparing giredestrant plus palbociclib against letrozole plus palbociclib in ER-positive, HER2-negative advanced or metastatic breast cancer, with progression-free survival as the primary endpoint. No efficacy or safety results are currently available in this registry record; the trial is active but no longer recruiting.

What was studied

Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer; age from 18 Years. Intervention: Giredestrant + Letrozole-matched Placebo + Palbociclib. Compared with: Letrozole + Giredestrant-matched Placebo + Palbociclib — Active Comparator. n = 992. 255 sites across 30 countries.

Key findings

Safety

This is a registry record; no efficacy or safety results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registration with no results posted; the study is active but not recruiting, and primary outcome data are not yet available in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 (assessed at From randomization to the first occurrence of disease progression or death from…)

DesignPhase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationEstrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer; age from 18 Years

Sample size992

InterventionGiredestrant + Letrozole-matched Placebo + Palbociclib

ComparatorLetrozole + Giredestrant-matched Placebo + Palbociclib — Active Comparator

Setting255 sites across 30 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment992

PhasePhase 3

Primary endpointProgression-Free Survival (PFS) by RECIST v1.1 from randomization to first disease progression or death from any cause, up to 78 months

Caveats

This is a registry record; no efficacy or safety results are reported.
Study is active but not recruiting; outcome data maturity and timing of publication are unknown.
Primary outcome measure is stated but no effect size, hazard ratio, or p-value is available.
Baseline characteristics, stratification factors, and statistical analysis plan are not described in this registry excerpt.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, randomized, double-blind, placebo-controlled, multicenter design.

Directness

strong

Primary endpoint is PFS by RECIST v1.1, a clinically relevant hard endpoint.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

moderate

Double-blind and placebo-controlled reduce bias; full methods and result reporting pending.

Sample adequacy

strong

Planned enrollment of 992 participants is adequate for Phase 3 primary endpoint detection.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04546009). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 992 participants (ACTUAL). Conditions: Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer. Interventions: DRUG: Giredestrant; DRUG: Giredestrant-matched Placebo; DRUG: Letrozole; DRUG: Letrozole-matched Placebo; DRUG: Palbociclib; DRUG: LHRH Agonist. Primary outcome measures: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 , From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months). Brief summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

GiredestrantGiredestrant-matched PlaceboLetrozoleLetrozole-matched PlaceboNCT04546009Estrogen Receptor Positive, HER2 Negative Locally Advanced Or Metastatic BreastHoffmann-La Roche