Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

478

Participants

Timeline

Start Date

May 10, 2019

Primary Completion Date

August 24, 2021

Study Completion Date

August 22, 2024

Conditions
Breast Cancer
Interventions
DRUG

Elacestrant

400 mg/day once daily oral dosing

DRUG

Standard of Care

"* Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle~* Anastrozole 1 mg/day on a continuous dosing schedule~* Letrozole: 2.5 mg/day on a continuous dosing schedule~* Exemestane: 25 mg/day on a continuous dosing schedule"

Trial Locations (244)

1000

Institut Jules Bordet - Oncologie Médicale, Brussels

1019

Centro Médico Austral, Buenos Aires

1020

CHU Brugmann, Brussels

1090

UZ Brussel - Campus Jette, Brussels

1145

Uzsoki Utcai Kórház, Budapest

1200

Cliniques Universitaires Saint-Luc - Oncology, Brussels

1340

Clinique Saint Pierre, Ottignies

2000

Oncología Médica, Rosario

2300

AZ Turnhout, Turnhout

2560

Macarthur Cancer Therapy, Campbelltown

2650

UZ Antwerpen - Oncologie, Edegem

2930

AZ Klina, Brasschaat

3000

Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute, Leuven

3065

St Vincent's Hospital Melbourne, Fitzroy

4032

Bács-Kiskun Megyei Kórház, Debrecen

4101

Mater Misericordiae Ltd Mater Cancer Care Centre, Brisbane

4400

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór, Nyíregyháza

4575

Sunshine Coast University Hospital, Birtinya

4600

Abteilung für Innere Medizin IV, Wels

Klinikum Wels-Grieskirchen GmbH, Wels

4700

Næstved Sygehus, Næstved

Onkologisk Afdeling, Lillebælt Hospital, Vejle, Næstved

5000

CHU UCL Namur - Site Sainte-Elisabeth, Namur

CHU UCL Namur Campus Sainte-Elisabeth, Namur

Odense Universitetshospital - Oncology, Odense

5004

Clínica Universitaria Reina Fabiola, Córdoba

Sanatorio del Salvador, Córdoba

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint, Szolnok

5300

Fundación CORI, La Rioja

6000

Grand Hôpital de Charleroi - Site Notre-Dame, Charleroi

6020

Universitätsklinik Innsbruck, Innsbruck

6800

Centre Hospitalier de l'Ardenne - Site de Libramont, Libramont

7032

Debreceni Egyetem Klinikai Központ, Debrecen

7100

INDC Entité Jolimontoise - CH de Jolimont-Lobbes, Haine-Saint-Paul

Vejle Sygehus, Vejle

7623

Pécsi Tudományegyetem Klinikai Központ, Pécs

8000

AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology, Bruges

8500

AZ Groeninge, Kortrijk

AZ Groeninge - Campus Kennedylaan, Kortrijk

8700

Department für Hämato-Onkologie - LKH Hochsteiermark, Leoben

Landeskrankenhaus (LKH) Leoben-Eisenerz, Leoben

9100

AZ Nikolaas - Campus Sint-Niklaas Moerland, Sint-Niklaas

Aalborg Universitetshospital, Aalborg

9300

Onze-Lieve-Vrouwziekenhuis Aalst, Aalst

10016

New York University Clinical Cancer Center, New York

10408

National Cancer Center, Goyang

10461

Montefiore Medical Center, The Bronx

10549

Northern Westchester Hospital Cancer Center, Mount Kisco

10601

Oncology and Hematology of White Plains, White Plains

11794

Stony Brook University, Stony Brook

12206

New York Oncology Hematology, Albany

13620

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre de Lutte Contre le Cancer (CLCC), Caen

Centre François Baclesse Service Pharmacie, Caen

16132

DiMI, Dipartimento di Medicina interna e Specialità mediche,, Genova

17109

Pinnacle Health Cancer Institute, Harrisburg

17325

Gettysburg Cancer Center, Gettysburg

18547

Metropolitan Hospital - Oncology Unit, Athens

19090

Abington Hematology Oncology Associates, Willow Grove

19096

Lankenau Medical Center, Wynnewood

20010

MedStar Washington Hospital Center, Washington D.C.

20089

IRCCS Istituto Clinico Humanitas Humanitas Cancer Center, Rozzano

20900

Ospedale San Gerardo-ASST Monza, Monza

21079

Centre Georges Francois Leclerc, Dijon

21202

The Gynecologic Oncology Center at Mercy, Baltimore

21237

Weinberg Cancer Institute at Franklin Square, Baltimore

21565

Gachon University Gil Medical Center, Incheon

21702

Maryland Oncology Hematology, Frederick

22031

Inova Schar Cancer Institute, Fairfax

22060

Fort Belvoir Community Hospital, Fort Belvoir

22908

University of Virginia Cancer Center, Charlottesville

26100

PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona, Cremona

26504

University General Hospital Of Patras - Dpt Of Medicine, Division Oncology, Pátrai

27100

IRCCS Policlinico San Matteo, Pavia

28033

M.D Anderson Center Madrid, Madrid

28034

IOB Ruber Internacional, Madrid

28040

Hospital Clínico San Carlos, Madrid

28041

Servicio de Oncología Médica Edificio Materno, Madrid

28046

Hospital Universitario La Paz, Madrid

28100

AOU Maggiore della Carità - SC Oncologia, Novara

28304

Carolina Institute For Clinical Research, Fayetteville

28942

Hospital Universitario de Fuenlabrada. Servicio de Oncología, Fuenlabrada

29414

Charleston Oncology, Charleston

29425

MUSC Hollings Cancer Center, Charleston

30046

Suburban Hematology-Oncology Associates, Lawrenceville

30060

Northwest Georgia Oncology Centers, Marietta

30318

Piedmont Cancer Institute, P.C. - Oncology, Atlanta

31008

Hospital de Navarra, Pamplona

31059

IUCT-Oncopole Pharmacie-Essais Cliniques, Toulouse

32806

Orlando Health Cancer Institute, Orlando

33100

Azienda Sanitaria Universitaria Integrata di Udine, Udine

33612

Moffitt Cancer Center, Tampa

34298

Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques, Montpellier

36312

Hospital Xeral Álvaro Cunqueiro, Vigo

37044

Hopital Trousseau - Service d'Oncologie Medicale, Tours

37909

Brig Center For Cancer Care And Survivorship, Knoxville

38138

West Cancer Center, Germantown

38320

Hospital de Dia de Oncología, San Cristóbal de La Laguna

Hospital Universitario de Canarias, Santa Cruz de Tenerife

39202

Jackson Oncology Associates, PLLC., Jackson

40138

Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni, Bologna

40207

Norton Cancer Institute, Louisville

41009

Hospital Universitario Virgen de la Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41100

Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena

41110

University General Hospital of Larissa, Larissa

41501

Pikeville Medical Center - Oncology/Hematology, Pikeville

42270

Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques, Saint-Priest-en-Jarez

43126

Azienda Ospedaliero-Universitaria di Parma, Parma

43623

Toledo Clinic Cancer Center, Toledo

44106

University Hospitals of Cleveland, Cleveland

45242

US Oncology Network, Cincinnati

45409

Dayton Oncology & Hematology, Kettering

46010

Hospital Clínico Universitario de Valencia, Valencia

46260

Hematology Oncology Of Indiana, Indianapolis

46321

Cancer Resource Centre, Munster

46526

Goshen Center for Cancer Care, Goshen

46815

Fort Wayne Medical Oncology And Hematology, Fort Wayne

47014

Regional Cancer Center, Meldola

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48201

Karmanos Cancer Institute, Detroit

53211

Colombia St. Mary's Medical Oncology, Milwaukee

53705

University of Wisconsin Carbone Cancer Center, Madison

54622

Bioclinic Thessaloniki, Thessaloniki

55404

Minnesota Oncology, Minneapolis

55905

Mayo Clinic, Rochester

56126

SO S.Chiara, AOU Pisana - Oncologia 2, Pisa

59020

Centre Oscar Lambret, Department de Cancérologie Sénologique, Lille

60077

Presence Medical Group Hematology Oncology, Skokie

60141

Chicago Association for Research and Education in Science, Chicago

60435

Joliet Oncology-Hematology Associates, Joliet

60487

Healthcare Research Network II, Tinley Park

60612

Rush University Cancer Center, Chicago

62526

Cancer Care Center of Decatur, Decatur

62702

Simmons Cancer Institute, Springfield

63011

Centre Jean Perrin, Clermont-Ferrand

65807

Chub O'Reilly Cancer Center, Springfield

66205

University of Kansas Cancer Center, Westwood

67000

Strasbourg Oncologie Libérale Centre de Radiothérapie, Strasbourg

68105

The Fred & Pamela Buffett Cancer Center, Omaha

69008

Centre Leon Berard Oncologie Médical, Lyon

Hôpital Privé Jean Mermoz Département Pharmacie, Lyon

70121

Ochsner Medical Center, New Orleans

71105

Highland Clinic, Shreveport

72401

St Bernard's Cancer Care, Jonesboro

75005

Centre DeLutte Contre Le Cancer - Institut Curie - Departement d'Oncologie Medica, Paris

75093

Texas Oncology-Plano West, Plano

75150

Texas Oncology-Mesquite, Mesquite

75203

Texas Oncology-Methodist Dallas Cancer Center, Dallas

75230

Texas Oncology-Medical City Dallas, Dallas

75231

Texas Oncology-Presbyterian Cancer Center Dallas, Dallas

75702

USO Texas Oncology - Tyler, Tyler

76022

Texas Oncology-Paris, Paris

77070

Texas Oncology - Willowbrook, Houston

77380

Renovatio Medical The Woodlands, The Woodlands

Texas Oncology - The Woodlands, Gynecologic Oncology, The Woodlands

77702

Texas Oncology-Beaumont, Beaumont

78053

Texas Oncology - McAllen, McAllen

78229

Cancer Therapy and Research Center at UTHSCSA, San Antonio

78731

Texas Oncology - Central Austin Cancer Center, Austin

78759

Austin Cancer Centers, Austin

Elligo Health Research, Austin

80045

Anschutz Cancer Center Pavilion, Aurora

80211

Texas Oncology-Plano East, Plano

80218

US Oncology - Rocky Mountain Cancer Centers - Midtown, Denver

80528

Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System, Fort Collins

UCHealth Cancer Center, Fort Collins

84124

Utah Cancer Specialists, Salt Lake City

85724

The University of Arizona Cancer Center, Tucson

87109

New Mexico Oncology Hematology Consultants - Oncology, Albuquerque

87131

New Mexico Cancer Care Alliance, Albuquerque

90033

Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS), Los Angeles

Keck Medical Center of USC, Los Angeles

USC IDS Pharmacy, Los Angeles

90095

UCLA Hematology/Oncology, Los Angeles

UCLA West Medical Pharmacy 159, Los Angeles

90277

TMPN Cancer Care, Redondo Beach

91206

Adventist Health Glendale, Glendale

92093

Moores Cancer Center at UC San Diego Health, La Jolla

92210

Institut Curie Saint-Cloud, Saint-Cloud

92835

St. Jude Heritage Healthcare, Fullerton

93105

Ridley-Tree Cancer Center, Santa Barbara

94115

UCSF Medical Center, San Francisco

95817

UC Davis Medical Center, Investigational Drug Service, Sacramento

97239

Oregon Health and Science University, Portland

98101

Benaroya Research Institute at Virginia Mason, Seattle

2210001

Galilee Medical Center, Nahariya

4428164

Meir Medical Center, Kfar Saba

4941492

Rabin Medical Center - Beilinson Hospital - Davidoff Cancer, Petah Tikva

5265601

The Chaim Sheba Medical Center, Tel-Hashomer

6423906

Tel Aviv Sourasky Medical Center - Oncology, Tel Aviv

7030000

Assaf Harofeh Medical Center, Ẕerifin

9103102

Sharett Institute of Oncology - Hadassah Medical Center, Jerusalem

Shaare Zedek Medical Center, Jerusalem

9112001

Hadassah MO - Oncology, Jerusalem

06511

Yale Cancer Center, New Haven

04074

New England Cancer Specialists, Scarborough

02111

Boston Medical Center, Boston

02114

Massachusetts General Hospital Cancer Center, Boston

02462

Mass General Cancer Center at Newton Wellesley - Oncology, Boston

01923

Mass General North Shore Cancer Center - Oncology, Danvers

07728

Precision Cancer Research, Freehold

07039

Saint Barnabas Medical Center - Cancer Center, Livingston

08876

The Steeplechase Cancer Center, Somerville

B2700KMP

Clínica Pergamino S.A., Pergamino

C1025ABI

Fundacion CENIT para la Investigación en Neurociencias - Clinic, Buenos Aires

C1280AEB

Oncología en Ciudad Autónoma de Buenos Aires, Buenos Aires

T4000GTB

Clínica Caipo, San Miguel de Tucumán

M4C 3E7

Oncology and Haematology Clinic - Michael Garron Hospital, East York

H2X 1R9

Pharmacie du CRCHUM, Montreal

H4A-3J1

McGill University Health Centre - Cedars Cancer Center - Oncology, Montreal

G1S 4L8

CHU de Quebec - Hopital du Saint Sacrement, Québec

H-1083

Semmelweis Egyetem, Onkológiai Központ,, Budapest

H-1122

Országos Onkológiai Intézet, Budapest

Unknown

Bon Secours Hospital [Oncology], Cork

D8

Clinical Research Facility, St. James's Hospital, Dublin

D9

Beaumont Hospital Cancer Clinical Trials Unit, Dublin

DUBLIN 4

St Vincent's University Hospital, Dublin

F91 H684

Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital, Sligo

Sligo University Hospital, Sligo

X91 ER8E

Pharmacy, UHW, Waterford

06132

Via G. Dottore, 1 Sc Oncologia Medica Azienda Ospedaliera di Perugia, Perugia

00128

Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,, Roma

00168

Policlinico A. Gemelli, Roma

3000-075

Instituto Português de Oncologia de Coimbra, Coimbra

4835-044

Hospital Senhora da Oliveira - Guimarães, E.P.E., Guimarães

1500-650

Hospital da Luz, Lisbon

4200-072

Instituto Português de Oncologia do Porto, Porto

Instituto Português Oncologia Francisco Gentil do Porto, Porto

03080

Seoul National University Hospital, Seoul

02841

Korea University Anam Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

03202

Hospital General Universitario de Elche, Elche

07010

Hospital Universitario Son Espases, Servicio de Oncología, Palma de Mallorca

08036

Hospital Clinic de Barcelona, Barcelona

HA6 2RN

Mount Vernon Cancer Centre, Northwood

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

ME16 9QQ

Kent Oncology Centre, Maidstone Hospital, Maidstone

TA1 5DA

Taunton and Somerset NHS Trust, Taunton

CF14 2TL

Velindre Cancer Centre - Oncology, Cardiff

NW1 2PG

University College London Hospitals, London

W1G 6AD

Sarah Cannon Research Institute, London

All Listed Sponsors
lead

Stemline Therapeutics, Inc.

INDUSTRY

NCT03778931 - Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer | Biotech Hunter | Biotech Hunter