OncRef

Clinical Trial: NCT04576455

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)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-09-11

Study Overview

Brief Summary

This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.

Official Title

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

Conditions

Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Intervention / Treatment

  • Drug: Giredestrant
  • Drug: Fulvestrant or an Aromatase Inhibitor (Physician Choice)
  • Drug: LHRH Agonist

Other Study ID Numbers

  • WO42312
  • 2020-001984-10

Start Date (Actual)

2020-11-27

Primary Completion Date (Actual)

2022-02-18

Study Completion Date (Estimated)

2027-08-25

Enrollment (Actual)

303

Study Type

Interventional

Phase

Phase 2