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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

992

Participants

Timeline

Start Date

October 9, 2020

Primary Completion Date

December 15, 2025

Study Completion Date

March 25, 2028

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 treatment cycle.

DRUG

Giredestrant-matched Placebo

Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Letrozole

Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Letrozole-matched Placebo

Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.

DRUG

Palbociclib

Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.

DRUG

LHRH Agonist

Only premenopausal/perimenopausal 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 (257)

41

Oncosalud Sac, Lima

100

National Taiwan Uni Hospital, Taipei

104

Mackay Memorial Hospital, Taipei

333

Chang Gung Memorial Hosipital at Linkou, Taoyuan Hsien

404

China Medical University Hospital, Taichung

704

National Cheng Kung Uni Hospital, Tainan City

1015

Organización medica de Investi, Cap Fed

1023

Auckland City Hospital, Auckland

1062

Honvédelmi Minisztérium Állami Egészségügyi Központ;Onkológiai Osztály, Budapest

1090

Medizinische Universität Wien, Vienna

1145

Budapesti Uzsoki Utcai Kórház, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

1425

Hospital de Onc Angel Roffo, Buenos Aires

2000

Hospital Provincial del Centenario, Rosario

2298

Calvary Mater Newcastle, Waratah

2730

Herlev Hospital, Herlev

3000

Peter MacCallum Cancer Centre-East Melbourne, Melbourne

3021

Sunshine Hospital, St Albans

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

4101

Mater Hospital Brisbane, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4400

A.Ö. LHK, Steyr

4700

Sjællands Universitetshospital, Næstved, Næstved

5000

Odense Universitetshospital, Onkologisk Afdeling R, Odense C

5020

Uniklinikum Salzburg, LKH, Salzburg

6150

Fiona Stanley Hospital - Medical Oncology, Murdoch

8208

Corporacio Sanitaria Parc Tauli, Sabadell

8308

Korea University Guro Hospital, Seoul

10060

Fondazione del Piemonte per l?Oncologia (IRCCS), Candiolo

10065

Memorial Sloan-Kettering Cancer Center, New York

10330

Chulalongkorn Hospital, Faculty of Medicine, Bangkok

10400

Rajavithi Hospital, Bangkok

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Gyeonggi-do

11725

MSKCC @ Commack, Commack

13014

Instituto Regional de Enfermedades Neoplasicas - IREN Norte, Trujillo

13581

Ambulantes Tumorzentrum Spandau, Berlin

13620

Seoul National University Bundang Hospital, Gyeonggi-do

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

20080

Hospital de Donostia, Donostia / San Sebastian

20141

Istituto Europeo Di Oncologia, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20249

Facharztzentrum Eppendorf, Studien GbR, Hamburg

20900

Asst Di Monza, Monza

20902

Maryland Oncology Hematology, Silver Spring

21202

Mercy Medical Center, Baltimore

21565

Gachon University Gil Medical Center, Incheon

22030

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne

22031

Inova Fairfax Hospital, Fairfax

23502

Virginia Oncology Associates, Norfolk

25123

Az. Osp. Spedali Civili, Brescia

28007

Hospital General Universitario Gregorio Marañon, Madrid

28033

Centro Oncologico MD Anderson Internacional, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28050

HM Sanchinarro ? CIOCC, Madrid

28223

Hospital Quiron de Madrid, Pozuelo de Alarcón

28644

Chungbuk National University Hospital, Cheongju-si

29414

Roper St. Francis Healthcare, Charleston

30625

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie, Hanover

31380

Kocaeli University Faculty of Medicine, İzmit

32308

SCRI Florida Cancer Specialists PAN, Tallahassee

33021

Memorial Regional Cancer Ctr, Hollywood

33136

University of Miami, Miami

33705

SCRI Florida Cancer Specialists North, St. Petersburg

33901

Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers

34214

Medipol University Medical Faculty, Istanbul

34298

Institut régional du Cancer Montpellier, Montpellier

34730

Medeniyet University Goztepe Training and Research Hospital., Istanbul

35042

Centre Eugene Marquis, Rennes

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

35360

Katip Celebi University Ataturk Training and Research Hospital, Izmir

36100

Azienda ULSS 8 Berica, Vicenza

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37073

Dres.Andreas Ammon und Dirk Meyer, Göttingen

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

38138

West Cancer Center, Germantown

40005

Sumy Regional Clinical Onc Ctr, Sumy

41013

Hospital Universitario Virgen del Rocio, Seville

41944

Kyungpook National University Medical Center, Daegu

42271

ICL, Saint-Priest-en-Jarez

44033

Ulsan University Hosiptal, Ulsan

44195

The Cleveland Clinic Foundation, Cleveland

44280

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya

45122

Universitätsklinikum Essen, Essen

46010

Hospital Clinico Universitario de Valencia, Valencia

47014

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola

49055

ICO Paul Papin, Angers

49100

Davidof Center - Rabin Medical Center, Petah Tikva

49102

Municipal Institution City Clinical Hospital #4 of Dnipro City Council, Dnipropetrovsk

49124

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte

50048

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council, Kryvyi Rih

50200

Maharaj Nakorn Chiang Mai Hosp, Chang Mai

51056

Institut Jean Godinot, Reims

53792

University of Wisconsin, Madison

53840

Dres. Helmut Forstbauer, Carsten Ziske und Kollegen, Troisdorf

54290

Klinikum Mutterhaus der Borromaeerinnen gGmbH, Trier

54511

Centre Alexis Vautrin, Vandœuvre-lès-Nancy

55139

19 Mayis University Medical Faculty, Samsun

56068

Praxis Köppler, Heymann, Weide, Thomalla, Koblenz

57124

Ospedale Civile - Livorno, Livorno

58260

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Morelia

61018

SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU, Kharkiv

63225

Dres. Andreas Köhler und Roswitha Fuchs, Langen

64109

Centre Hospitalier de La Cote Basque, Bayonne

64132

HCA Midwest Division, Kansas City

64460

Filios Alta Medicina, Monterrey

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

68167

Universitätsklinikum Mannheim, Mannheim

69120

Nationales Centrum für Tumorerkrankungen (NCT), Heidelberg

72076

Universitätsklinik Tübingen, Tübingen

75246

Texas Oncology - DFW, Dallas

76018

Ivano-Frankivsk Regional Oncology Center, Ivano-Frankivsk

76104

The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth

77030

Baylor St. Luke's Medical Center, Houston

Houston Methodist Hospital, Houston

78209

Oncologico Potosino, San Luis Potosí City

80218

Rocky Mountain Cancer Center, Denver

80336

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt, München

85925

Chd de Vendee, La Roche-sur-Yon

86021

Chu La Miletrie, Poitiers

87401

San Juan Oncology Associates, Farmington

88212

MVZ für Hämatologie und Onkologie Ravensburg GmBH, Ravensburg

90110

Songklanagarind Hospital, Songkhla

90806

Long Beach Memorial Medical Center, Long Beach

91900

Sociedad de Metabolismo y Corazón (SOMECO), Veracruz

92708

Orange Coast Memorial Medical Center, Fountain Valley

94305

Stanford Univ Medical Center, Stanford

94577

Kaiser Permanente - San Leandro Medical Center, San Leandro

94596

Kaiser Permanente - Walnut Creek, Walnut Creek

95045

Humanitas Centro Catanese Di Oncologia, Misterbianco (CT)

97213

Providence Portland Medical Ctr, Portland

98405

Northwest Medical Specialties, Tacoma

100142

Beijing Cancer Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

110042

Liaoning cancer Hospital & Institute, Shenyang

111123

"SBIH Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva

130021

The First Hospital of Jilin University, Changchun

142100

Podolsk City Clinical Hospital, Podolsk

150081

Harbin Medical University Cancer Hospital, Harbin

197758

GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), Saint Petersburg

233000

the First Affiliated Hospital of Bengbu Medical College, Bengbu

250117

Shandong Cancer Hospital, Jinan

310016

Sir Run Run Shaw Hospital Zhejiang University, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

350001

Fujian Medical University Union Hospital, Fujian

390011

Ryazan Regional clinical oncology dispensary, Ryazan

410013

Hunan Cancer Hospital, Changsha

430032

Respublikanskiy Onkologicheskiy Dispanser, Saransk

443011

Multidisciplinary clinic Reaviz, Samara

454087

Chelyabinsk region oncology dispensary, Chelyabinsk

455000

Anyang Tumor Hosptial, Anyang

510000

Sun Yat-sen Memorial Hospital, Guangzhou

510060

Sun Yet-sen University Cancer Center, Guangzhou

530021

Guangxi Cancer Hospital of Guangxi Medical University, Nanning

546450

Euromedical General Clinic of Thessaloniki, Thessaloniki

710061

The First Affiliated Hospital of Xian Jiao Tong University, Xi'an

6423906

Tel Aviv Sourasky Medical Ctr, Tel Aviv

80045-2517

University of Colorado, Aurora

96819-1469

Kaiser Permanente - Moanalua Medical Center, Honolulu

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07920

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge

08816

Astera Cancer Care East Brunswick, East Brunswick

07645

Memorial Sloan Kettering Cancer Center at Bergen, Montvale

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

C1280AEB

Hospital Britanico, Ciudad Autonoma Bs As

S2000KZE

Instituto de Oncología de Rosario, Rosario

B1602DQD

CEMER Centro Medico de Enfermedades Respiratorias, Vicente López

41253-190

Hospital Sao Rafael - HSR, Salvador

74605-070

Hospital Araujo Jorge, Goiânia

50040-000

Hospital do Cancer de Pernambuco - HCP, Recife

90050-170

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

15090-000

Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto

01317-000

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

01323-900

Beneficencia Portuguesa de Sao Paulo, São Paulo

T2N 5G2

Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary

V3V 1Z2

BC Cancer ? Surrey, Surrey

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

L6R 3J7

William Osler Health System Brampton Civic Hospital, Brampton

K1Y 4E9

Ottawa Hospital Research Institute, Ottawa

M5G 2M9

Princess Margaret Cancer Center, Toronto

H1T 2M4

Universite de Montreal - Hopital Maisonneuve-Rosemont, Montreal

H2X 3E4

Centre Hospitalier de l?Université de Montréal (CHUM), Montreal

H3T 1E2

Jewish General Hospital, Montreal

H4A 3J1

McGill University Health Center, Montreal

G1S 4L8

Hopital du Saint Sacrement, Québec

071000

Affiliated Hospital of Hebei University, Baoding

09116

Klinikum Chemnitz gGmbH, Chemnitz

01307

"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden

04277

St. Elisabeth-Krankenhaus, Senologie/Brustzentrum, Leipzig

115 22

Anticancer Hospital Ag Savas, Athens

Anticancer Hospital Ag. Savas, Athens

570 01

European Interbalkan Medical Center, Thessaloniki

Unknown

Pamela Youde Nethersole Eastern Hospital, Hong Kong

Princess Margaret Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

Centro Hospitalar Lisboa Norte, Lisbon

52620-00

Chaim Sheba Medical Center, Ramat Gan

00144

IRCCS Istituto Regina Elena (IFO), Rome

466-8560

Nagoya University Hospital, Aichi

260-8717

Chiba Cancer Center, Chiba

277-8577

National Cancer Center Hospital East, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

734-8551

Hiroshima University Hospital, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

673-0021

Hyogo Cancer Center, Hyōgo

305-8576

University of Tsukuba Hospital, Ibaraki

892-0833

Sagara Hospital, Kagoshima

241-8515

Kanagawa Cancer Center, Kanagawa

259-1193

Tokai University Hospital, Kanagawa

860-8556

Kumamoto University Hospital, Kumamoto

960-1295

Fukushima Medical University Hospital, Miyagi

951-8566

Niigata Cancer Center Hospital, Niigata

901-0154

Naha-nishi Clinic, Okinawa

540-0006

National Hospital Organization Osaka National Hospital, Osaka

541-8567

Osaka International Cancer Institute, Osaka

362-0806

Saitama Cancer Center, Saitama

104-0045

National Cancer Center Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

142-8666

Showa Medical University Hospital, Tokyo

03810

Health Pharma Professional Research, CD Mexico

06760

Centro Medico Dalinde, Mexico City

Lima 27

Instituto Peruano de Oncología y Radioterapia, Lima

Clinica Ricardo Palma, San Isidro

Lima 34

Instituto Nacional de Enfermedades Neoplasicas, Lima

80-214

Uniwersyteckie Centrum Kliniczne, Gda?sk

81-519

Szpital Morski im. PCK, Gdynia

02-781

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

3000-075

IPO de Coimbra, Coimbra

1500-650

Hospital da Luz, Lisbon

4200-072

IPO do Porto, Porto

02841

Korea University Anam Hospital, Seoul

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

08908

Hospital Duran i Reynals, L'Hospitalet de Llobregat

08003

Hospital del Mar, Barcelona

08028

Hospital Universitari Dexeus - Grupo Quironsalud, Barcelona

08035

Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

00112

Veterans General Hospital, Taipei

06100

Hacettepe Uni Medical Faculty Hospital, Ankara

06490

Ankara Bilkent City Hospital, Ankara

BN2 5BE

Royal Sussex County Hospital, Brighton

LE1 5WW

Leicester Royal Infirmary, Leicester

NW1 - 2PG

University College London Hospital, London

NW3 2QS

Royal Free Hospital, London

SE1 9RT

Guys & St Thomas Hospital, London

ME16 0FS

Maidstone Hospital, Maidstone

PE3 9GZ

Peterborough City Hospital, Peterborough

PL6 8DH

Derriford Hospital, Plymouth

SM2 5PT

Royal Marsden Hosp NHS Fnd, Sutton

TR1 3LQ

Royal Cornwall Hospital, Truro

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY