# A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

Source: https://onco.cc/trials/nct04576455/  
OnCo record `nct04576455` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Giredestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.

## Summary

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer) is a phase 2 interventional study registered as NCT04576455 by Hoffmann-La Roche, with 303 participants enrolled, started 2020-11-27 and due to reach its primary completion in 2022-02-18. Interventions recorded: Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice) and LHRH Agonist. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04576455
- Phase: 2
- Setting: A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
- Sponsor: Hoffmann-La Roche
- Enrolled: 303
- Outcomes: Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1): Giredestrant 5.55 months vs Physician's Choice of Endocrine Monotherapy 5.36 months, HR 0.81; Overall Survival (OS): Giredestrant 27.5 months vs Physician's Choice of Endocrine Monotherapy 29.77 months, HR 1.16

## Sources

- ClinicalTrials.gov NCT04576455: https://clinicaltrials.gov/study/NCT04576455

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- drugs: [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Giredestrant](https://onco.cc/drugs/giredestrant/)
- companies: [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)
- key papers: [Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study](https://onco.cc/key-papers/paper-nct04576455-j-clin-oncol-2024/)

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