Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD)

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Elacestrant; Drug: Standard of Care

Detailed Description

This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5004
    • Clinica Universitaria Reina Fabiola
  • Córdoba, Argentina, 5004
    • Sanatorio del Salvador
  • La Rioja, Argentina, 5300
    • Fundación CORI
  • Buenos Aires
    • Pergamino, Buenos Aires, Argentina, B2700KMP
      • Clínica Pergamino S.A.
  • Ciudad Autonoma De Buenos Aires
    • Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1025ABI
      • Fundacion CENIT para la Investigación en Neurociencias - Clinic
  • Ciudad Autónoma De Buenos Aire
    • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, 1019
      • Centro Medico Austral
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1280AEB
      • Oncología en Ciudad Autónoma de Buenos Aires
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Oncologia Medica
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000GTB
      • Clínica Caipo
• Australia
  • Birtinya, Australia, 4575
    • Sunshine Coast University Hospital
  • Campbelltown, Australia, 2560
    • Macarthur Cancer Therapy
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Ltd Mater Cancer Care Centre
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
• Austria
  • Oberösterreich
    • Wels, Oberösterreich, Austria, 4600
      • Klinikum Wels-Grieskirchen GmbH
    • Wels, Oberösterreich, Austria, 4600
      • Abteilung für Innere Medizin IV
  • Steiermark
    • Leoben, Steiermark, Austria, 8700
      • Landeskrankenhaus (LKH) Leoben-Eisenerz
    • Leoben, Steiermark, Austria, 8700
      • Department für Hämato-Onkologie - LKH Hochsteiermark
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Universitätsklinik Innsbruck
• Belgium
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Campus Kennedylaan
  • Namur, Belgium, 5000
    • CHU UCL Namur - Site Sainte-Elisabeth
  • Namur, Belgium, 5000
    • CHU UCL Namur Campus Sainte-Elisabeth
  • Ottignies, Belgium, 1340
    • Clinique Saint Pierre
  • Antwerpen
    • Brasschaat, Antwerpen, Belgium, 2930
      • AZ Klina
    • Edegem, Antwerpen, Belgium, 2650
      • UZ Antwerpen - Oncologie
    • Turnhout, Antwerpen, Belgium, 2300
      • AZ Turnhout
  • Brussels Capital Region
    • Brussel, Brussels Capital Region, Belgium, 1090
      • UZ Brussel - Campus Jette
    • Brussels, Brussels Capital Region, Belgium, 1000
      • Institut Jules Bordet - Oncologie Médicale
    • Bruxelles, Brussels Capital Region, Belgium, 1020
      • CHU Brugmann
    • Bruxelles, Brussels Capital Region, Belgium, 1200
      • Cliniques Universitaires Saint-Luc - Oncology
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital de Charleroi - Site Notre-Dame
    • Haine-Saint-Paul, Hainaut, Belgium, 7100
      • INDC Entité Jolimontoise - CH de Jolimont-Lobbes
  • Luxembourg
    • Libramont, Luxembourg, Belgium, 6800
      • Centre Hospitalier de l'Ardenne - Site de Libramont
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Onze-Lieve-Vrouwziekenhuis Aalst
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • AZ Nikolaas - Campus Sint-Niklaas Moerland
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Az Groeninge
• Canada
  • Québec, Canada, G1S 4L8
    • CHU de Quebec - Hopital du Saint Sacrement
  • Ontario
    • East York, Ontario, Canada, M4C 3E7
      • Oncology and Haematology Clinic - Michael Garron Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 1R9
      • Pharmacie du CRCHUM
    • Montreal, Quebec, Canada, H4A-3J1
      • McGill University Health Centre - Cedars Cancer Center - Oncology
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg Universitetshospital
  • Odense, Denmark, 5000
    • Odense Universitetshospital - Oncology
  • South Denmark
    • Vejle, South Denmark, Denmark, 7100
      • Vejle Sygehus
  • Zeeland
    • Næstved, Zeeland, Denmark, 4700
      • Næstved Sygehus
    • Næstved, Zeeland, Denmark, 4700
      • Onkologisk Afdeling, Lillebælt Hospital, Vejle
• France
  • Caen, France, 14076
    • Centre François Baclesse Service Pharmacie
  • Dijon, France, 21079
    • Centre Georges François Leclerc
  • Montpellier, France, 34298
    • Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques
  • Paris, France, 75005
    • Centre DeLutte Contre Le Cancer - Institut Curie - Departement d'Oncologie Medica
  • Saint-Priest-en-Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • Strasbourg Oncologie Libérale Centre de Radiothérapie
  • Calvados
    • Caen, Calvados, France, 14076
      • Centre de Lutte Contre le Cancer (CLCC)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • IUCT-Oncopole Pharmacie-Essais Cliniques
  • Indre-et-Loire
    • Tours, Indre-et-Loire, France, 37044
      • Hopital Trousseau - Service d'Oncologie Medicale
  • Nord
    • Lille, Nord, France, 59020
      • Centre Oscar Lambret, Department de Cancérologie Sénologique
  • Puy-de-Dôme
    • Clermont Ferrand, Puy-de-Dôme, France, 63011
      • Centre Jean Perrin
  • Rhône
    • Lyon, Rhône, France, 69008
      • Centre Leon Berard Oncologie Médical
    • Lyon, Rhône, France, 69008
      • Hôpital Privé Jean Mermoz Département Pharmacie
  • Île-de-France
    • Saint-Cloud, Île-de-France, France, 92210
      • Institut Curie Saint-Cloud
• Greece
  • Thessaloniki, Greece, 54622
    • Bioclinic Thessaloniki
  • Achaïa
    • Patra, Achaïa, Greece, 26504
      • University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
  • Attiki
    • Athens, Attiki, Greece, 18547
      • Metropolitan Hospital - Oncology Unit
  • Larisa
    • Larissa, Larisa, Greece, 41110
      • University General Hospital of Larissa
• Hungary
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Kórház
  • Budapest, Hungary, H-1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, H-1083
    • Semmelweis Egyetem, Onkológiai Központ,
  • Baranya
    • Pécs, Baranya, Hungary, 7623
      • Pécsi Tudományegyetem Klinikai Központ
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Bacs-kiskun Megyei Korhaz
    • Debrecen, Hajdú-Bihar, Hungary, 7032
      • Debreceni Egyetem Klinikai Kozpont
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
      • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
  • Szabolcs-Szatmár-Bereg
    • Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
• Ireland
  • Dublin, Ireland, DUBLIN 4
    • St Vincent's University Hospital
  • Dublin, Ireland, D8
    • Clinical Research Facility, St. James's Hospital
  • Dublin, Ireland, D9
    • Beaumont Hospital Cancer Clinical Trials Unit
  • Sligo, Ireland, F91 H684
    • Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital
  • Sligo, Ireland, F91 H684
    • Sligo University Hospital
  • Waterford, Ireland, X91 ER8E
    • Pharmacy, UHW
  • Cork
    • Cork City, Cork, Ireland
      • Bon Secours Hospital [Oncology]
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah MO - Oncology
  • Kfar-Saba, Israel, 4428164
    • Meir Medical Center
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center - Beilinson Hospital - Davidoff Cancer
  • Tel-Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center - Oncology
  • Zerifin, Israel, 7030000
    • Assaf Harofeh Medical Center
  • HaMerkaz
    • Jerusalem, HaMerkaz, Israel, 9103102
      • Sharett Institute of Oncology - Hadassah Medical Center
    • Tel-Hashomer, HaMerkaz, Israel, 5265601
      • The Chaim Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni
  • Cremona, Italy, 26100
    • PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
  • Genova, Italy, 16132
    • DiMI, Dipartimento di Medicina interna e Specialità mediche,
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Modena, Italy, 41100
    • Azienda Ospedaliero-Universitaria Policlinico di Modena
  • Novara, Italy, 28100
    • AOU Maggiore della Carità - SC Oncologia
  • Parma, Italy, 43126
    • Azienda Ospedaliero-Universitaria di Parma
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo
  • Perugia, Italy, 06132
    • Via G. Dottore, 1 Sc Oncologia Medica Azienda Ospedaliera di Perugia
  • Pisa, Italy, 56126
    • SO S.Chiara, AOU Pisana - Oncologia 2
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,
  • Roma, Italy, 00168
    • Policlinico A. Gemelli
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Integrata di Udine
  • Forli-Cesena
    • Meldola, Forli-Cesena, Italy, 47014
      • Regional Cancer Center
  • Milano
    • Rozzano, Milano, Italy, 20089
      • IRCCS Istituto Clinico Humanitas Humanitas Cancer Center
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • Ospedale San Gerardo-ASST Monza
• Korea, Republic of
  • Goyang, Korea, Republic of, 10408
    • National Cancer Center
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital
• Portugal
  • Coimbra, Portugal, 3000-075
    • Instituto Português de Oncologia de Coimbra
  • Guimarães, Portugal, 4835-044
    • Hospital Senhora da Oliveira - Guimarães, E.P.E.
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz
  • Porto, Portugal, 4200-072
    • Instituto Português Oncologia Francisco Gentil do Porto
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • IOB Ruber Internacional
  • Madrid, Spain, 28033
    • M.D Anderson Center Madrid
  • Madrid, Spain, 28041
    • Servicio de Oncología Médica Edificio Materno
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen De La Macarena
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Hospital General Universitario de Elche
  • Andalucía
    • Sevilla, Andalucía, Spain, 41013
      • Hospital Universitario Virgen del Rocio
  • Canarias
    • La Laguna, Canarias, Spain, 38320
      • Hospital de Dia de Oncología
    • Tenerife, Canarias, Spain, 38320
      • Hospital Universitario de Canarias
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07010
      • Hospital Universitario Son Espases, Servicio de Oncología
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada. Servicio de Oncología
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Hospital Xeral Álvaro Cunqueiro
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre - Oncology
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals
  • England
    • Northwood, England, United Kingdom, HA6 2RN
      • Mount Vernon Cancer Centre
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust
  • Kent
    • Maidstone, Kent, United Kingdom, ME16 9QQ
      • Kent Oncology Centre, Maidstone Hospital
  • Somerset
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Taunton and Somerset NHS Trust
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Cancer Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St Bernard's Cancer Care
  • California
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Healthcare
    • Glendale, California, United States, 91206
      • Adventist Health Glendale
    • La Jolla, California, United States, 92093
      • Moores Cancer Center at UC San Diego Health
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Los Angeles, California, United States, 90033
      • USC IDS Pharmacy
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)
    • Los Angeles, California, United States, 90095
      • UCLA West Medical Pharmacy 159
    • Redondo Beach, California, United States, 90277
      • TMPN Cancer Care
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center, Investigational Drug Service
    • San Francisco, California, United States, 94115
      • UCSF Medical Center
    • Santa Barbara, California, United States, 93105
      • Ridley-Tree Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Cancer Center Pavilion
    • Denver, Colorado, United States, 80218
      • US Oncology - Rocky Mountain Cancer Centers - Midtown
    • Fort Collins, Colorado, United States, 80528
      • Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
    • Fort Collins, Colorado, United States, 80528
      • UCHealth Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Piedmont Cancer Institute, P.C. - Oncology
    • Lawrenceville, Georgia, United States, 30046
      • Suburban Hematology-Oncology Associates
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Cancer Center
    • Chicago, Illinois, United States, 60141
      • Chicago Association for Research and Education in Science
    • Decatur, Illinois, United States, 62526
      • Cancer Care Center of Decatur
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates
    • Skokie, Illinois, United States, 60077
      • Presence Medical Group Hematology Oncology
    • Springfield, Illinois, United States, 62702
      • Simmons Cancer Institute
    • Tinley Park, Illinois, United States, 60487
      • Healthcare Research Network II
  • Indiana
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Medical Oncology and Hematology
    • Goshen, Indiana, United States, 46526
      • Goshen Center For Cancer Care
    • Indianapolis, Indiana, United States, 46260
      • Hematology Oncology Of Indiana
    • Munster, Indiana, United States, 46321
      • Cancer Resource Centre
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
    • Pikeville, Kentucky, United States, 41501
      • Pikeville Medical Center - Oncology/Hematology
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
    • Shreveport, Louisiana, United States, 71105
      • Highland Clinic
  • Maine
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Weinberg Cancer Institute at Franklin Square
    • Baltimore, Maryland, United States, 21202
      • The Gynecologic Oncology Center at Mercy
    • Frederick, Maryland, United States, 21702
      • Maryland Oncology Hematology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Boston, Massachusetts, United States, 02462
      • Mass General Cancer Center at Newton Wellesley - Oncology
    • Boston, Massachusetts, United States, 02111
      • Boston Medical Center
    • Danvers, Massachusetts, United States, 01923
      • Mass General North Shore Cancer Center - Oncology
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Jackson Oncology Associates, PLLC.
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Chub O'Reilly Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • The Fred & Pamela Buffett Cancer Center
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Precision Cancer Research
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center - Cancer Center
    • Somerville, New Jersey, United States, 08876
      • The Steeplechase Cancer Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • New Mexico Cancer Care Alliance
    • Albuquerque, New Mexico, United States, 87109
      • New Mexico Oncology Hematology Consultants - Oncology
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Mount Kisco, New York, United States, 10549
      • Northern Westchester Hospital Cancer Center
    • New York, New York, United States, 10016
      • New York University Clinical Cancer Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
    • White Plains, New York, United States, 10601
      • Oncology and Hematology of White Plains
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Carolina Institute for Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • US Oncology Network
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Kettering, Ohio, United States, 45409
      • Dayton Oncology & Hematology
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Harrisburg, Pennsylvania, United States, 17109
      • Pinnacle Health Cancer Institute
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Hematology Oncology Associates
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology
    • Charleston, South Carolina, United States, 29425
      • MUSC Hollings Cancer Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center
    • Knoxville, Tennessee, United States, 37909
      • Brig Center for Cancer Care and Survivorship
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Central Austin Cancer Center
    • Austin, Texas, United States, 78759
      • Austin Cancer Centers
    • Austin, Texas, United States, 78759
      • Elligo Health Research
    • Beaumont, Texas, United States, 77702
      • Texas Oncology-Beaumont
    • Dallas, Texas, United States, 75230
      • Texas Oncology-Medical City Dallas
    • Dallas, Texas, United States, 75203
      • Texas Oncology-Methodist Dallas Cancer Center
    • Dallas, Texas, United States, 75231
      • Texas Oncology-Presbyterian Cancer Center Dallas
    • Houston, Texas, United States, 77070
      • Texas Oncology - Willowbrook
    • McAllen, Texas, United States, 78053
      • Texas Oncology - McAllen
    • Mesquite, Texas, United States, 75150
      • Texas Oncology-Mesquite
    • Paris, Texas, United States, 76022
      • Texas Oncology-Paris
    • Plano, Texas, United States, 75093
      • Texas Oncology-Plano West
    • Plano, Texas, United States, 80211
      • Texas Oncology-Plano East
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Research Center at UTHSCSA
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands, Gynecologic Oncology
    • The Woodlands, Texas, United States, 77380
      • Renovatio Medical The Woodlands
    • Tyler, Texas, United States, 75702
      • USO Texas Oncology - Tyler
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Utah Cancer Specialists
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute
    • Fort Belvoir, Virginia, United States, 22060
      • Fort Belvoir Community Hospital
  • Washington
    • Seattle, Washington, United States, 98101
      • Benaroya Research Institute at Virginia Mason
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Carbone Cancer Center
    • Milwaukee, Wisconsin, United States, 53211
      • Colombia St. Mary's Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Critical Inclusion Criteria:

1. Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.
2. Subjects must be appropriate candidates for endocrine monotherapy
3. Subjects must have measurable disease or nonmeasurable (evaluable) bone-only disease
4. Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).
5. Subjects must have ER+/HER2- tumor status
6. Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.
7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
8. Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.
9. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized.

Critical Exclusion Criteria:

1. Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist.

2. Prior anticancer or investigational drug treatment within the following windows:

   1. Fulvestrant treatment < 28 days before first dose of study drug
   2. Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects)
   3. Chemotherapy < 21 days before first dose of study drug
   4. Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor
3. Presence of symptomatic visceral disease as defined in protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elacestrant; Subjects in Arm 1 will receive elacestrant	Drug: Elacestrant; 400 mg/day once daily oral dosing; Other Names: RAD1901
Active Comparator: Standard of Care (SoC); Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)	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; Other Names: Faslodex, Arimidex, Femara, Aromasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival in ESR1-mut Subjects	Progression-free Survival based on blinded IRC assessment in ESR1-mut subjects defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Progression-free Survival in All Subjects	Progression-free Survival based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects	From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in ESR1-mut Subjects	Overall Survival in ESR1-mut subjects, where Overall Survival is defined as the length of time from randomization until the date of death from any cause	From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Overall Survival in All Subjects	Overall Survival in All (ESR1-mut and ESR1-WT) Subjects	From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

Collaborators and Investigators

• Sponsor: Stemline Therapeutics, Inc.
• Investigators: Study Director: Sr. Director, Clinical Operations, Radius Health, Inc.

Publications and helpful links

General Publications

• Bardia A, Aftimos P, Bihani T, Anderson-Villaluz AT, Jung J, Conlan MG, Kaklamani VG. EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.
• Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, Garcia Saenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortes J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3962.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): August 24, 2021
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant; Anastrozole
• Other Study ID Numbers: RAD1901-308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No