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)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

November 27, 2020

Primary Completion Date

February 18, 2022

Study Completion Date

August 25, 2027

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

Trial Locations (85)

333

Chang Gung Memorial Hosipital at Linkou, Taoyuan Hsien

500

Changhua Christian Hospital, Changhua

704

National Cheng Kung Uni Hospital, Tainan City

710

Chi-Mei Medical Centre, Tainan City

1417

Instituto Angel Roffo, Buenos Aires

2010

Kinghorn Cancer Centre, Darlinghurst

3021

Sunshine Hospital, St Albans

6045

Cancercare Langenhoven Drive Oncology Centre, Port Elizabeth

9301

Iatros International, Bloemfontein

10330

Chulalongkorn Hospital, Bangkok

10400

Rajavithi Hospital, Bangkok

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Goyang-si

14169

Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche, Berlin

18439

Gynäkologie Kompetenzzentrum, Stralsund

20357

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg

21280

Dicle University Faculty of Medicine, Diyarbakır

30060

Northwest Georgia Oncology Centers PC - Marietta, Marietta

31151

Soon Chun Hyang University Cheonan Hospital, Dongnam-gu, Cheonan-si

33098

St. Vincenz-Krankenhaus Paderborn, Paderborn

34000

Kartal Dr Lutfi Kirdar Sehir Hastanesi, Istanbul

34384

Prof. Dr. Cemil Tascioglu City Hospital, Istanbul

35360

Katip Celebi University Ataturk Training and Research Hospital, Izmir

40005

RCI Sumy Regional Clinical Oncological Dispensary, Sumy

44106

University Hospitals Seidman Cancer Center, Cleveland

50200

Maharaj Nakorn Chiang Mai Hosp, Chang Mai

55200

Medikal Park Samsun, Samsun

63739

Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg, Aschaffenburg

90110

Songklanagarind Hospital, Songkhla

97223

Northwest Cancer Specialists - Portland (SW Barnes Rd), Tigard

115478

Blokhin Cancer Research Center, Moskva

119228

National University Hospital, Singapore

130021

The First Hospital of Jilin University, Changchun

150040

Regional Clinical Oncology Hospital, Yaroslavl

150081

Harbin Medical University Cancer Hospital, Harbin

169610

National Cancer Centre, Singapore

197022

"St. Petersburg SHI City Clinical Oncology Dispensary", Saint Petersburg

197758

Petrov Research Inst. of Oncology, Pesochny

200120

Fudan University Shanghai Cancer Center, Shanghai

276034

Linyishi Cancer Hospital, Linyi

300060

Tianjin Cancer Hospital, Tianjin

310022

Zhejiang Cancer Hospital, Zhejiang

330000

The Third Hospital of Nanchang, Nanchang

350040

Clinical Oncology Centre # 1, Krasnodar

400138

Volgograd Regional Clinical Oncology Dispensary, Volgograd

420029

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan'

430079

Hubei Cancer Hospital, Wuhan

443011

Multidisciplinary clinic Reaviz, Samara

510060

Sun Yet-sen University Cancer Center, Guangzhou

603081

Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod, Nizhny Novgorod

660133

Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky, Krasnoyarsk

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

4428164

Meir Medical Center, Kfar Saba

9112000

Hadassah Ein Karem Hospital, Jerusalem

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

M5500AYB

Fundación Scherbovsky, Mendoza

S2002KDS

Hosp Provincial D. Centenarios, Rosario

C1015ABO

Organizacion Medica de Investigacion, San Nicolás

60810-180

Pronutrir - suporte nutricional e quimioterapia ltda., Fortaleza

98700-000

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

90050-170

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

01317-001

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo

04014-002

Núcleo de Pesquisa São Camilo, São Paulo

Unknown

Assuta Medical Center- Ashdod, Ashdod

Zhytomyr Regional Oncology Center, Zhytomyr

15-027

Bialostockie Centrum Onkologii, Bialystok

44-102

Narodowy Instytut Onkologii Odzia? w Gliwicach, Gliwice

02-781

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad, Warsaw

0081

Eastleigh Breast Care Centre, Pretoria

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

06591

Seoul St Mary's Hospital, Seoul

00112

Veterans General Hospital, Taipei

06520

Memorial Ankara Hastanesi, Ankara

06800

Ankara City Hospital, Ankara

07020

Memorial Antalya Hospital, Antalya

03115

Kyiv City Clinical Oncological Center, Kyiv

04107

MI Kyiv Regional Council Kyiv Regional Oncological Dispensary, Kyiv

CM20 1QX

Princess Alexandra Hospital, Harlow

SE1 9RT

Guys & St Thomas Hospital, London

NG5 1PB

Nottingham City Hospital, Nottingham

PE3 9GZ

Peterborough City Hospital, Peterborough

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY