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)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Giredestrant	Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.
DRUG	Fulvestrant or an Aromatase Inhibitor (Physician Choice)	Physician choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.
DRUG	LHRH Agonist	Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Timeline

• Start date: 2020-11-27
• Primary completion: 2022-02-18
• Completion: 2027-08-25
• First posted: 2020-10-06
• Last updated: 2026-03-20
• Results posted: 2023-03-10

Locations

80 sites across 17 countries: United States, Argentina, Australia, Brazil, China, Germany, Israel, Poland, Russia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study