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AzTrials

Breast CancerPhase 3EMERALDNCT03778931

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

A Phase 3 study testing Elacestrant in people with Breast Cancer, run by Stemline Therapeutics, Inc. at 244 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Elacestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
478 participants
Where
244 sitesin 17 countries
Study dates
10 May 2019to 22 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Critical Inclusion Criteria:

  1. 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.
  2. Participants must be appropriate candidates for endocrine monotherapy
  3. Participants must have measurable disease or bone only disease with evaluable lesions
  4. 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).
  5. Participants must have ER+ and HER2- tumor status
  6. 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.
  7. 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).
  8. Participants may have received no more than one line of chemotherapy in the advanced/metastatic setting.

Critical Exclusion Criteria:

  1. 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).
  2. Prior anticancer or investigational drug treatment within the following windows:
  3. Fulvestrant treatment < 42 days before first dose of study drug
  4. Any endocrine therapy < 14 days before first dose of study drug
  5. Chemotherapy < 21 days before first dose of study drug
  6. 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
  7. Bisphosphonates or RANKL inhibitors initiated or dose changed < 3 months prior to first dose of study drug
  8. Presence of symptomatic visceral disease as defined in protocol.

Trial locations and contacts

244 sites in 17 countries.

244 sites in 17 countries

United States104 sites

  • New York Oncology Hematology

    Albany, New York, 12206

  • New Mexico Oncology Hematology Consultants - Oncology

    Albuquerque, New Mexico, 87109

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87131

  • Piedmont Cancer Institute, P.C. - Oncology

    Atlanta, Georgia, 30318

  • Anschutz Cancer Center Pavilion

    Aurora, Colorado, 80045

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731

  • Austin Cancer Centers

    Austin, Texas, 78759

  • Elligo Health Research

    Austin, Texas, 78759

  • The Gynecologic Oncology Center at Mercy

    Baltimore, Maryland, 21202

  • Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • Texas Oncology-Beaumont

    Beaumont, Texas, 77702

  • Boston Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Mass General Cancer Center at Newton Wellesley - Oncology

    Boston, Massachusetts, 02462

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Chicago Association for Research and Education in Science

    Chicago, Illinois, 60141

  • Rush University Cancer Center

    Chicago, Illinois, 60612

  • US Oncology Network

    Cincinnati, Ohio, 45242

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Texas Oncology-Methodist Dallas Cancer Center

    Dallas, Texas, 75203

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology-Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231

  • Mass General North Shore Cancer Center - Oncology

    Danvers, Massachusetts, 01923

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • US Oncology - Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Carolina Institute For Clinical Research

    Fayetteville, North Carolina, 28304

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

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

    Fort Collins, Colorado, 80528

  • UCHealth Cancer Center

    Fort Collins, Colorado, 80528

  • Fort Wayne Medical Oncology And Hematology

    Fort Wayne, Indiana, 46815

  • Maryland Oncology Hematology

    Frederick, Maryland, 21702

  • Precision Cancer Research

    Freehold, New Jersey, 07728

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Adventist Health Glendale

    Glendale, California, 91206

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Pinnacle Health Cancer Institute

    Harrisburg, Pennsylvania, 17109

  • Texas Oncology - Willowbrook

    Houston, Texas, 77070

  • Hematology Oncology Of Indiana

    Indianapolis, Indiana, 46260

  • Jackson Oncology Associates, PLLC.

    Jackson, Mississippi, 39202

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois, 60435

  • St Bernard's Cancer Care

    Jonesboro, Arkansas, 72401

  • Dayton Oncology & Hematology

    Kettering, Ohio, 45409

  • Brig Center For Cancer Care And Survivorship

    Knoxville, Tennessee, 37909

  • Moores Cancer Center at UC San Diego Health

    La Jolla, California, 92093

  • Suburban Hematology-Oncology Associates

    Lawrenceville, Georgia, 30046

  • Saint Barnabas Medical Center - Cancer Center

    Livingston, New Jersey, 07039

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

    Los Angeles, California, 90033

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • USC IDS Pharmacy

    Los Angeles, California, 90033

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • UCLA West Medical Pharmacy 159

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Texas Oncology - McAllen

    McAllen, Texas, 78053

  • Texas Oncology-Mesquite

    Mesquite, Texas, 75150

  • Colombia St. Mary's Medical Oncology

    Milwaukee, Wisconsin, 53211

  • Minnesota Oncology

    Minneapolis, Minnesota, 55404

  • Northern Westchester Hospital Cancer Center

    Mount Kisco, New York, 10549

  • Cancer Resource Centre

    Munster, Indiana, 46321

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Clinical Cancer Center

    New York, New York, 10016

  • The Fred & Pamela Buffett Cancer Center

    Omaha, Nebraska, 68105

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Texas Oncology-Paris

    Paris, Texas, 76022

  • Pikeville Medical Center - Oncology/Hematology

    Pikeville, Kentucky, 41501

  • Texas Oncology-Plano West

    Plano, Texas, 75093

  • Texas Oncology-Plano East

    Plano, Texas, 80211

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • TMPN Cancer Care

    Redondo Beach, California, 90277

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC Davis Medical Center, Investigational Drug Service

    Sacramento, California, 95817

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84124

  • Cancer Therapy and Research Center at UTHSCSA

    San Antonio, Texas, 78229

  • UCSF Medical Center

    San Francisco, California, 94115

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Presence Medical Group Hematology Oncology

    Skokie, Illinois, 60077

  • The Steeplechase Cancer Center

    Somerville, New Jersey, 08876

  • Simmons Cancer Institute

    Springfield, Illinois, 62702

  • Chub O'Reilly Cancer Center

    Springfield, Missouri, 65807

  • Stony Brook University

    Stony Brook, New York, 11794

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Renovatio Medical The Woodlands

    The Woodlands, Texas, 77380

  • Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

  • Healthcare Research Network II

    Tinley Park, Illinois, 60487

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • USO Texas Oncology - Tyler

    Tyler, Texas, 75702

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Oncology and Hematology of White Plains

    White Plains, New York, 10601

  • Abington Hematology Oncology Associates

    Willow Grove, Pennsylvania, 19090

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Belgium19 sites

  • Onze-Lieve-Vrouwziekenhuis Aalst

    Aalst, Oost-Vlaanderen, 9300

  • AZ Klina

    Brasschaat, Antwerpen, 2930

  • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

    Bruges, West-Vlaanderen, 8000

  • Institut Jules Bordet - Oncologie Médicale

    Brussels, Brussels Capital, 1000

  • CHU Brugmann

    Brussels, Brussels Capital, 1020

  • UZ Brussel - Campus Jette

    Brussels, Brussels Capital, 1090

  • Cliniques Universitaires Saint-Luc - Oncology

    Brussels, Brussels Capital, 1200

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi, Hainaut, 6000

  • UZ Antwerpen - Oncologie

    Edegem, Antwerpen, 2650

  • INDC Entité Jolimontoise - CH de Jolimont-Lobbes

    Haine-Saint-Paul, Hainaut, 7100

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute

    Leuven, Vlaams Brabant, 3000

  • Centre Hospitalier de l'Ardenne - Site de Libramont

    Libramont, Luxembourg, 6800

  • CHU UCL Namur - Site Sainte-Elisabeth

    Namur, 5000

  • CHU UCL Namur Campus Sainte-Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, 1340

  • AZ Nikolaas - Campus Sint-Niklaas Moerland

    Sint-Niklaas, Oost-Vlaanderen, 9100

  • AZ Turnhout

    Turnhout, Antwerpen, 2300

Other trials in Belgium

Italy16 sites

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

    Bologna, 40138

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

    Cremona, 26100

  • DiMI, Dipartimento di Medicina interna e Specialità mediche,

    Genova, 16132

  • Regional Cancer Center

    Meldola, Forli-Cesena, 47014

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena, 41100

  • Ospedale San Gerardo-ASST Monza

    Monza, Monza E Brianza, 20900

  • AOU Maggiore della Carità - SC Oncologia

    Novara, 28100

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

  • IRCCS Policlinico San Matteo

    Pavia, 27100

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

    Perugia, 06132

  • SO S.Chiara, AOU Pisana - Oncologia 2

    Pisa, 56126

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

    Roma, 00128

  • Policlinico A. Gemelli

    Roma, 00168

  • IRCCS Istituto Clinico Humanitas Humanitas Cancer Center

    Rozzano, Milano, 20089

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 33100

Other trials in Italy

Spain16 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario de Elche

    Elche, Alicante, 03202

  • Hospital Universitario de Fuenlabrada. Servicio de Oncología

    Fuenlabrada, Madrid, 28942

  • M.D Anderson Center Madrid

    Madrid, 28033

  • IOB Ruber Internacional

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Servicio de Oncología Médica Edificio Materno

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Son Espases, Servicio de Oncología

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Dia de Oncología

    San Cristóbal de La Laguna, Canary Islands, 38320

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands, 38320

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Universitario Virgen de la Macarena

    Seville, 41009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Xeral Álvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

France14 sites

  • Centre de Lutte Contre le Cancer (CLCC)

    Caen, Calvados, 14076

  • Centre François Baclesse Service Pharmacie

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, Puy-de-Dôme, 63011

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Centre Oscar Lambret, Department de Cancérologie Sénologique

    Lille, Nord, 59020

  • Centre Leon Berard Oncologie Médical

    Lyon, Rhône, 69008

  • Hôpital Privé Jean Mermoz Département Pharmacie

    Lyon, Rhône, 69008

  • Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques

    Montpellier, 34298

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

    Paris, 75005

  • Institut Curie Saint-Cloud

    Saint-Cloud, Île-de-France Region, 92210

  • Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques

    Saint-Priest-en-Jarez, 42270

  • Strasbourg Oncologie Libérale Centre de Radiothérapie

    Strasbourg, Bas-Rhin, 67000

  • IUCT-Oncopole Pharmacie-Essais Cliniques

    Toulouse, Haute-Garonne, 31059

  • Hopital Trousseau - Service d'Oncologie Medicale

    Tours, Indre-et-Loire, 37044

Other trials in France

Argentina9 sites

  • Fundacion CENIT para la Investigación en Neurociencias - Clinic

    Buenos Aires, Buenos Aires F.D., C1025ABI

  • Oncología en Ciudad Autónoma de Buenos Aires

    Buenos Aires, Buenos Aires F.D., C1280AEB

  • Centro Médico Austral

    Buenos Aires, Ciudad Autónoma de Buenos Aire, 1019

  • Clínica Universitaria Reina Fabiola

    Córdoba, 5004

  • Sanatorio del Salvador

    Córdoba, 5004

  • Fundación CORI

    La Rioja, 5300

  • Clínica Pergamino S.A.

    Pergamino, Buenos Aires, B2700KMP

  • Oncología Médica

    Rosario, Santa Fe Province, 2000

  • Clínica Caipo

    San Miguel de Tucumán, Tucumán Province, T4000GTB

Other trials in Argentina

Israel9 sites

  • Sharett Institute of Oncology - Hadassah Medical Center

    Jerusalem, Central District, 9103102

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah MO - Oncology

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center - Beilinson Hospital - Davidoff Cancer

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center - Oncology

    Tel Aviv, 6423906

  • The Chaim Sheba Medical Center

    Tel-Hashomer, Central District, 5265601

  • Assaf Harofeh Medical Center

    Tsrifin, 7030000

Other trials in Israel

Hungary8 sites

  • Uzsoki Utcai Kórház

    Budapest, 1145

  • Semmelweis Egyetem, Onkológiai Központ,

    Budapest, H-1083

  • Országos Onkológiai Intézet

    Budapest, H-1122

  • Bács-Kiskun Megyei Kórház

    Debrecen, Hajdú-Bihar, 4032

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, 7032

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7623

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

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

South Korea8 sites

  • National Cancer Center

    Goyang, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Ireland7 sites

  • Bon Secours Hospital [Oncology]

    Cork, Cork

  • Clinical Research Facility, St. James's Hospital

    Dublin, D8

  • Beaumont Hospital Cancer Clinical Trials Unit

    Dublin, D9

  • St Vincent's University Hospital

    Dublin, DUBLIN 4

  • Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital

    Sligo, F91 H684

  • Sligo University Hospital

    Sligo, F91 H684

  • Pharmacy, UHW

    Waterford, X91 ER8E

Other trials in Ireland

United Kingdom7 sites

  • Velindre Cancer Centre - Oncology

    Cardiff, CF14 2TL

  • University College London Hospitals

    London, NW1 2PG

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • Kent Oncology Centre, Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

  • Mount Vernon Cancer Centre

    Northwood, England, HA6 2RN

  • University Hospital Southampton NHS Foundation Trust

    Southampton, Hampshire, SO16 6YD

  • Taunton and Somerset NHS Trust

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Austria5 sites

  • Universitätsklinik Innsbruck

    Innsbruck, Tyrol, 6020

  • Department für Hämato-Onkologie - LKH Hochsteiermark

    Leoben, Styria, 8700

  • Landeskrankenhaus (LKH) Leoben-Eisenerz

    Leoben, Styria, 8700

  • Abteilung für Innere Medizin IV

    Wels, Upper Austria, 4600

  • Klinikum Wels-Grieskirchen GmbH

    Wels, Upper Austria, 4600

Other trials in Austria

Denmark5 sites

  • Aalborg Universitetshospital

    Aalborg, 9100

  • Næstved Sygehus

    Næstved, Region Sjælland, 4700

  • Onkologisk Afdeling, Lillebælt Hospital, Vejle

    Næstved, Region Sjælland, 4700

  • Odense Universitetshospital - Oncology

    Odense, 5000

  • Vejle Sygehus

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Portugal5 sites

  • Instituto Português de Oncologia de Coimbra

    Coimbra, 3000-075

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

    Guimarães, 4835-044

  • Hospital da Luz

    Lisbon, 1500-650

  • Instituto Português de Oncologia do Porto

    Porto, 4200-072

  • Instituto Português Oncologia Francisco Gentil do Porto

    Porto, 4200-072

Other trials in Portugal

Australia4 sites

  • Sunshine Coast University Hospital

    Birtinya, 4575

  • Mater Misericordiae Ltd Mater Cancer Care Centre

    Brisbane, Queensland, 4101

  • Macarthur Cancer Therapy

    Campbelltown, 2560

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

Other trials in Australia

Canada4 sites

  • Oncology and Haematology Clinic - Michael Garron Hospital

    East York, Ontario, M4C 3E7

  • Pharmacie du CRCHUM

    Montreal, Quebec, H2X 1R9

  • McGill University Health Centre - Cedars Cancer Center - Oncology

    Montreal, Quebec, H4A-3J1

  • CHU de Quebec - Hopital du Saint Sacrement

    Québec, G1S 4L8

Other trials in Canada

Greece4 sites

  • Metropolitan Hospital - Oncology Unit

    Athens, Attica, 18547

  • University General Hospital of Larissa

    Larissa, Larisa, 41110

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

    Pátrai, Achaïa, 26504

  • Bioclinic Thessaloniki

    Thessaloniki, 54622

Other trials in Greece

About this study

Official title: 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).

Read the 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 participants with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut participants) or in all participants 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.

Conditions
Breast Cancer
Being tested
Elacestrant, Standard of Care
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    Also called RAD1901, ORSERDU

    400 mg/day once daily oral dosing

  • Standard of CareDrug

    Also called Faslodex, Arimidex, Femara, Aromasin

    • 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
Study groups in NCT03778931
Study groupRoleWhat they receive
ElacestrantExperimentalParticipants in Arm 1 will receive elacestrant.
Receives: Drug: 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).
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)

  2. 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.

    Measured: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)

Secondary outcomes (2)

  1. Overall Survival in ESR1-mut Participants

    Overall survival in ESR1-mut participants, where overall survival is defined as the length of time from randomization until the date of death from any cause.

    Measured: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

  2. Overall Survival in All Participants

    Overall survival in all (ESR1-mut and ESR1-wt) participants.

    Measured: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start10 May 2019
  3. Primary completion24 Aug 2021
  4. Study completion22 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778931
Sponsor's protocol ID
RAD1901-308
Acronym
EMERALD
Status last verified
Aug 2025
First submitted
3 Dec 2018
Last updated
15 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 38381994

  • 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.

    PubMed 35584336

  • 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.

    PubMed 31426673

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elacestrant in people with Breast Cancer, run by Stemline Therapeutics, Inc. at 244 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in United States, Belgium, Italy, Spain, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival in ESR1-mut Participants (time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778931, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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