Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of 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
1 other identifier
interventional
478
16 countries
240
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started May 2019
240 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2021
CompletedResults Posted
Study results publicly available
December 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2024
CompletedSeptember 15, 2025
August 1, 2025
2.3 years
December 3, 2018
March 20, 2023
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival in ESR1-mut Participants
Progression-free survival based on blinded IRC assessment in ESR1-mut participants 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 Participants
Progression-free survival based on blinded imaging review committee (IRC) assessment in all (ESR1-mut and ESR1-wt) participants.
From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Secondary Outcomes (2)
Overall Survival in ESR1-mut Participants
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Overall Survival in All Participants
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Study Arms (2)
Elacestrant
EXPERIMENTALParticipants in Arm 1 will receive elacestrant.
Standard of Care (SoC)
ACTIVE COMPARATORParticipants in Arm 2 will receive investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane).
Interventions
* 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
Eligibility Criteria
You may qualify if:
- Participants 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.
- Participants must be appropriate candidates for endocrine monotherapy
- Participants must have measurable disease or bone only disease with evaluable lesions
- Female or male participants age ≥ 18 years; female participants must be postmenopausal women, and male participants must not allow pregnancy with their sperm (abstain, do not donate sperm, et cetera).
- Participants must have ER+ and HER2- tumor status
- Participants 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.
- Participants must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI) for advanced/metastatic breast cancer (mBC).
- Participants may have received no more than one line of chemotherapy in the advanced/metastatic setting.
You may not qualify if:
- Prior treatment with elacestrant or other investigational selective estrogen receptor degrader (SERD) or ER antagonist (D-0502, GDC-0810, GDC-0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasofoxifene).
- Prior anticancer or investigational drug treatment within the following windows:
- Fulvestrant treatment \< 42 days before first dose of study drug
- Any endocrine therapy \< 14 days before first dose of study drug
- Chemotherapy \< 21 days before first dose of study drug
- Any investigational anti-cancer drug therapy \< 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of participants whose most recent therapy was an investigational agent should be discussed with the Sponsor
- Bisphosphonates or RANKL inhibitors initiated or dose changed \< 3 months prior to first dose of study drug
- Presence of symptomatic visceral disease as defined in protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (244)
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
St Bernard's Cancer Care
Jonesboro, Arkansas, 72401, United States
St. Jude Heritage Healthcare
Fullerton, California, 92835, United States
Adventist Health Glendale
Glendale, California, 91206, United States
Moores Cancer Center at UC San Diego Health
La Jolla, California, 92093, United States
Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)
Los Angeles, California, 90033, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
USC IDS Pharmacy
Los Angeles, California, 90033, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
UCLA West Medical Pharmacy 159
Los Angeles, California, 90095, United States
TMPN Cancer Care
Redondo Beach, California, 90277, United States
UC Davis Medical Center, Investigational Drug Service
Sacramento, California, 95817, United States
UCSF Medical Center
San Francisco, California, 94115, United States
Ridley-Tree Cancer Center
Santa Barbara, California, 93105, United States
Anschutz Cancer Center Pavilion
Aurora, Colorado, 80045, United States
US Oncology - Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, 80218, United States
Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
Fort Collins, Colorado, 80528, United States
UCHealth Cancer Center
Fort Collins, Colorado, 80528, United States
Yale Cancer Center
New Haven, Connecticut, 06511, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Piedmont Cancer Institute, P.C. - Oncology
Atlanta, Georgia, 30318, United States
Suburban Hematology-Oncology Associates
Lawrenceville, Georgia, 30046, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
Chicago Association for Research and Education in Science
Chicago, Illinois, 60141, United States
Rush University Cancer Center
Chicago, Illinois, 60612, United States
Cancer Care Center of Decatur
Decatur, Illinois, 62526, United States
Joliet Oncology-Hematology Associates
Joliet, Illinois, 60435, United States
Presence Medical Group Hematology Oncology
Skokie, Illinois, 60077, United States
Simmons Cancer Institute
Springfield, Illinois, 62702, United States
Healthcare Research Network II
Tinley Park, Illinois, 60487, United States
Fort Wayne Medical Oncology And Hematology
Fort Wayne, Indiana, 46815, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Hematology Oncology Of Indiana
Indianapolis, Indiana, 46260, United States
Cancer Resource Centre
Munster, Indiana, 46321, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Pikeville Medical Center - Oncology/Hematology
Pikeville, Kentucky, 41501, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Highland Clinic
Shreveport, Louisiana, 71105, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
The Gynecologic Oncology Center at Mercy
Baltimore, Maryland, 21202, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237, United States
Maryland Oncology Hematology
Frederick, Maryland, 21702, United States
Boston Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Mass General Cancer Center at Newton Wellesley - Oncology
Boston, Massachusetts, 02462, United States
Mass General North Shore Cancer Center - Oncology
Danvers, Massachusetts, 01923, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Minnesota Oncology
Minneapolis, Minnesota, 55404, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Jackson Oncology Associates, PLLC.
Jackson, Mississippi, 39202, United States
Chub O'Reilly Cancer Center
Springfield, Missouri, 65807, United States
The Fred & Pamela Buffett Cancer Center
Omaha, Nebraska, 68105, United States
Precision Cancer Research
Freehold, New Jersey, 07728, United States
Saint Barnabas Medical Center - Cancer Center
Livingston, New Jersey, 07039, United States
The Steeplechase Cancer Center
Somerville, New Jersey, 08876, United States
New Mexico Oncology Hematology Consultants - Oncology
Albuquerque, New Mexico, 87109, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131, United States
New York Oncology Hematology
Albany, New York, 12206, United States
Northern Westchester Hospital Cancer Center
Mount Kisco, New York, 10549, United States
New York University Clinical Cancer Center
New York, New York, 10016, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Oncology and Hematology of White Plains
White Plains, New York, 10601, United States
Carolina Institute For Clinical Research
Fayetteville, North Carolina, 28304, United States
US Oncology Network
Cincinnati, Ohio, 45242, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Dayton Oncology & Hematology
Kettering, Ohio, 45409, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Pinnacle Health Cancer Institute
Harrisburg, Pennsylvania, 17109, United States
Abington Hematology Oncology Associates
Willow Grove, Pennsylvania, 19090, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Charleston Oncology
Charleston, South Carolina, 29414, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
West Cancer Center
Germantown, Tennessee, 38138, United States
Brig Center For Cancer Care And Survivorship
Knoxville, Tennessee, 37909, United States
Texas Oncology - Central Austin Cancer Center
Austin, Texas, 78731, United States
Austin Cancer Centers
Austin, Texas, 78759, United States
Elligo Health Research
Austin, Texas, 78759, United States
Texas Oncology-Beaumont
Beaumont, Texas, 77702, United States
Texas Oncology-Methodist Dallas Cancer Center
Dallas, Texas, 75203, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas, Texas, 75231, United States
Texas Oncology - Willowbrook
Houston, Texas, 77070, United States
Texas Oncology - McAllen
McAllen, Texas, 78053, United States
Texas Oncology-Mesquite
Mesquite, Texas, 75150, United States
Texas Oncology-Paris
Paris, Texas, 76022, United States
Texas Oncology-Plano West
Plano, Texas, 75093, United States
Texas Oncology-Plano East
Plano, Texas, 80211, United States
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229, United States
Renovatio Medical The Woodlands
The Woodlands, Texas, 77380, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380, United States
USO Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84124, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
Colombia St. Mary's Medical Oncology
Milwaukee, Wisconsin, 53211, United States
Clínica Pergamino S.A.
Pergamino, Buenos Aires, B2700KMP, Argentina
Fundacion CENIT para la Investigación en Neurociencias - Clinic
Buenos Aires, Buenos Aires F.D., C1025ABI, Argentina
Oncología en Ciudad Autónoma de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina
Centro Médico Austral
Buenos Aires, Ciudad Autónoma de Buenos Aire, 1019, Argentina
Oncología Médica
Rosario, Santa Fe Province, 2000, Argentina
Clínica Caipo
San Miguel de Tucumán, Tucumán Province, T4000GTB, Argentina
Clínica Universitaria Reina Fabiola
Córdoba, 5004, Argentina
Sanatorio del Salvador
Córdoba, 5004, Argentina
Fundación CORI
La Rioja, 5300, Argentina
Mater Misericordiae Ltd Mater Cancer Care Centre
Brisbane, Queensland, 4101, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Macarthur Cancer Therapy
Campbelltown, 2560, Australia
Department für Hämato-Onkologie - LKH Hochsteiermark
Leoben, Styria, 8700, Austria
Landeskrankenhaus (LKH) Leoben-Eisenerz
Leoben, Styria, 8700, Austria
Universitätsklinik Innsbruck
Innsbruck, Tyrol, 6020, Austria
Abteilung für Innere Medizin IV
Wels, Upper Austria, 4600, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, 4600, Austria
AZ Klina
Brasschaat, Antwerpen, 2930, Belgium
UZ Antwerpen - Oncologie
Edegem, Antwerpen, 2650, Belgium
AZ Turnhout
Turnhout, Antwerpen, 2300, Belgium
Institut Jules Bordet - Oncologie Médicale
Brussels, Brussels Capital, 1000, Belgium
CHU Brugmann
Brussels, Brussels Capital, 1020, Belgium
UZ Brussel - Campus Jette
Brussels, Brussels Capital, 1090, Belgium
Cliniques Universitaires Saint-Luc - Oncology
Brussels, Brussels Capital, 1200, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Hainaut, 6000, Belgium
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
Haine-Saint-Paul, Hainaut, 7100, Belgium
Centre Hospitalier de l'Ardenne - Site de Libramont
Libramont, Luxembourg, 6800, Belgium
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, Oost-Vlaanderen, 9300, Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute
Leuven, Vlaams Brabant, 3000, Belgium
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
Bruges, West-Vlaanderen, 8000, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk, 8500, Belgium
CHU UCL Namur - Site Sainte-Elisabeth
Namur, 5000, Belgium
CHU UCL Namur Campus Sainte-Elisabeth
Namur, 5000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
Oncology and Haematology Clinic - Michael Garron Hospital
East York, Ontario, M4C 3E7, Canada
Pharmacie du CRCHUM
Montreal, Quebec, H2X 1R9, Canada
McGill University Health Centre - Cedars Cancer Center - Oncology
Montreal, Quebec, H4A-3J1, Canada
CHU de Quebec - Hopital du Saint Sacrement
Québec, G1S 4L8, Canada
Vejle Sygehus
Vejle, Region Syddanmark, 7100, Denmark
Næstved Sygehus
Næstved, Zeeland, 4700, Denmark
Onkologisk Afdeling, Lillebælt Hospital, Vejle
Næstved, Zeeland, 4700, Denmark
Aalborg Universitetshospital
Aalborg, 9100, Denmark
Odense Universitetshospital - Oncology
Odense, 5000, Denmark
Strasbourg Oncologie Libérale Centre de Radiothérapie
Strasbourg, Bas-Rhin, 67000, France
Centre de Lutte Contre le Cancer (CLCC)
Caen, Calvados, 14076, France
IUCT-Oncopole Pharmacie-Essais Cliniques
Toulouse, Haute-Garonne, 31059, France
Hopital Trousseau - Service d'Oncologie Medicale
Tours, Indre-et-Loire, 37044, France
Centre Oscar Lambret, Department de Cancérologie Sénologique
Lille, Nord, 59020, France
Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, 63011, France
Centre Leon Berard Oncologie Médical
Lyon, Rhône, 69008, France
Hôpital Privé Jean Mermoz Département Pharmacie
Lyon, Rhône, 69008, France
Centre François Baclesse Service Pharmacie
Caen, 14076, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques
Montpellier, 34298, France
Centre DeLutte Contre Le Cancer - Institut Curie - Departement d'Oncologie Medica
Paris, 75005, France
Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques
Saint-Priest-en-Jarez, 42270, France
Institut Curie Saint-Cloud
Saint-Cloud, Île-de-France Region, 92210, France
University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
Pátrai, Achaïa, 26504, Greece
Metropolitan Hospital - Oncology Unit
Athens, Attica, 18547, Greece
University General Hospital of Larissa
Larissa, Larisa, 41110, Greece
Bioclinic Thessaloniki
Thessaloniki, 54622, Greece
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, 7623, Hungary
Bács-Kiskun Megyei Kórház
Debrecen, Hajdú-Bihar, 4032, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, 7032, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Uzsoki Utcai Kórház
Budapest, 1145, Hungary
Semmelweis Egyetem, Onkológiai Központ,
Budapest, H-1083, Hungary
Országos Onkológiai Intézet
Budapest, H-1122, Hungary
Bon Secours Hospital [Oncology]
Cork, Cork, Ireland
Clinical Research Facility, St. James's Hospital
Dublin, D8, Ireland
Beaumont Hospital Cancer Clinical Trials Unit
Dublin, D9, Ireland
St Vincent's University Hospital
Dublin, DUBLIN 4, Ireland
Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital
Sligo, F91 H684, Ireland
Sligo University Hospital
Sligo, F91 H684, Ireland
Pharmacy, UHW
Waterford, X91 ER8E, Ireland
Sharett Institute of Oncology - Hadassah Medical Center
Jerusalem, Central District, 9103102, Israel
The Chaim Sheba Medical Center
Tel-Hashomer, Central District, 5265601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah MO - Oncology
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center - Beilinson Hospital - Davidoff Cancer
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center - Oncology
Tel Aviv, 6423906, Israel
Assaf Harofeh Medical Center
Ẕerifin, 7030000, Israel
Regional Cancer Center
Meldola, Forli-Cesena, 47014, Italy
IRCCS Istituto Clinico Humanitas Humanitas Cancer Center
Rozzano, Milano, 20089, Italy
Ospedale San Gerardo-ASST Monza
Monza, Monza E Brianza, 20900, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni
Bologna, 40138, Italy
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
Cremona, 26100, Italy
DiMI, Dipartimento di Medicina interna e Specialità mediche,
Genova, 16132, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41100, Italy
AOU Maggiore della Carità - SC Oncologia
Novara, 28100, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Via G. Dottore, 1 Sc Oncologia Medica Azienda Ospedaliera di Perugia
Perugia, 06132, Italy
SO S.Chiara, AOU Pisana - Oncologia 2
Pisa, 56126, Italy
Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,
Roma, 00128, Italy
Policlinico A. Gemelli
Roma, 00168, Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, 33100, Italy
Instituto Português de Oncologia de Coimbra
Coimbra, 3000-075, Portugal
Hospital Senhora da Oliveira - Guimarães, E.P.E.
Guimarães, 4835-044, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Instituto Português de Oncologia do Porto
Porto, 4200-072, Portugal
Instituto Português Oncologia Francisco Gentil do Porto
Porto, 4200-072, Portugal
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
National Cancer Center
Goyang, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03202, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Universitario Son Espases, Servicio de Oncología
Palma de Mallorca, Balearic Islands, 07010, Spain
Hospital de Dia de Oncología
San Cristóbal de La Laguna, Canary Islands, 38320, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320, Spain
Hospital Universitario de Fuenlabrada. Servicio de Oncología
Fuenlabrada, Madrid, 28942, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Xeral Álvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
M.D Anderson Center Madrid
Madrid, 28033, Spain
IOB Ruber Internacional
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Servicio de Oncología Médica Edificio Materno
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Mount Vernon Cancer Centre
Northwood, England, HA6 2RN, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Kent Oncology Centre, Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
Taunton and Somerset NHS Trust
Taunton, Somerset, TA1 5DA, United Kingdom
Velindre Cancer Centre - Oncology
Cardiff, CF14 2TL, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
Related Publications (3)
Shah M, Lingam H, Gao X, Gittleman H, Fiero MH, Krol D, Biel N, Ricks TK, Fu W, Hamed S, Li F, Sun JJ, Fan J, Schuck R, Grimstein M, Tang L, Kalavar S, Abukhdeir A, Pathak A, Ghosh S, Bulatao I, Tilley A, Pierce WF, Mixter BD, Tang S, Pazdur R, Kluetz P, Amiri-Kordestani L. US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer. J Clin Oncol. 2024 Apr 1;42(10):1193-1201. doi: 10.1200/JCO.23.02112. Epub 2024 Feb 21.
PMID: 38381994DERIVEDBidard 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. doi: 10.1200/JCO.23.01239.
PMID: 35584336DERIVEDBardia 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.
PMID: 31426673DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carlos A. Garay, MD, Senior Vice President, Clinical Development & Medical Affairs - Solid Tumors
- Organization
- Stemline Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2018
First Posted
December 19, 2018
Study Start
May 10, 2019
Primary Completion
August 24, 2021
Study Completion
August 22, 2024
Last Updated
September 15, 2025
Results First Posted
December 5, 2023
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share