Clinical trial NCT03778931: Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Stemline Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

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.

Eligibility criteria: 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 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+ and 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) for advanced/metastatic breast cancer (mBC).
8. Subjects 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:

   1. Fulvestrant treatment \< 42 days before first dose of study drug
   2. Any endocrine therapy \< 14 days before first dose of study drug
   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
   5. Bisphosphonates or RANKL inhibitors initiated or dose changed \< 3 months prior to first dose of study drug
3. Presence of symptomatic visceral disease as defined in protocol.

Primary outcomes:
measure: Progression-free Survival in ESR1-mut Subjects
timeFrame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
measure: Progression-free Survival in All Subjects
timeFrame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Secondary outcomes:
measure: Overall Survival in ESR1-mut Subjects
timeFrame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
measure: Overall Survival in All Subjects
timeFrame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Jonesboro
country: United States
facility: St Bernard's Cancer Care
state: Arkansas
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego Health
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: USC IDS Pharmacy
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy 159
state: California
city: Redondo Beach
country: United States
facility: TMPN Cancer Care
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center, Investigational Drug Service
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Santa Barbara
country: United States
facility: Ridley-Tree Cancer Center
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Center Pavilion
state: Colorado
city: Denver
country: United States
facility: US Oncology - Rocky Mountain Cancer Centers - Midtown
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, P.C. - Oncology
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Chicago
country: United States
facility: Chicago Association for Research and Education in Science
state: Illinois
city: Chicago
country: United States
facility: Rush University Cancer Center
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Center of Decatur
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates
state: Illinois
city: Skokie
country: United States
facility: Presence Medical Group Hematology Oncology
state: Illinois
city: Springfield
country: United States
facility: Simmons Cancer Institute
state: Illinois
city: Tinley Park
country: United States
facility: Healthcare Research Network II
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology And Hematology
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Hematology Oncology Of Indiana
state: Indiana
city: Munster
country: United States
facility: Cancer Resource Centre
state: Indiana
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Pikeville
country: United States
facility: Pikeville Medical Center - Oncology/Hematology
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Highland Clinic
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: The Gynecologic Oncology Center at Mercy
state: Maryland
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Frederick
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Mass General Cancer Center at Newton Wellesley - Oncology
state: Massachusetts
city: Danvers
country: United States
facility: Mass General North Shore Cancer Center - Oncology
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC.
state: Mississippi
city: Springfield
country: United States
facility: Chub O'Reilly Cancer Center
state: Missouri
city: Omaha
country: United States
facility: The Fred & Pamela Buffett Cancer Center
state: Nebraska
city: Freehold
country: United States
facility: Precision Cancer Research
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Medical Center - Cancer Center
state: New Jersey
city: Somerville
country: United States
facility: The Steeplechase Cancer Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants - Oncology
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital Cancer Center
state: New York
city: New York
country: United States
facility: New York University Clinical Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: White Plains
country: United States
facility: Oncology and Hematology of White Plains
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute For Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: US Oncology Network
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Kettering
country: United States
facility: Dayton Oncology & Hematology
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Cancer Institute
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hematology Oncology Associates
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology
state: South Carolina
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Knoxville
country: United States
facility: Brig Center For Cancer Care And Survivorship
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Central Austin Cancer Center
state: Texas
city: Austin
country: United States
facility: Austin Cancer Centers
state: Texas
city: Austin
country: United States
facility: Elligo Health Research
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology-Beaumont
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Methodist Dallas Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Presbyterian Cancer Center Dallas
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Willowbrook
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology-Mesquite
state: Texas
city: Paris
country: United States
facility: Texas Oncology-Paris
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano West
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center at UTHSCSA
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Medical The Woodlands
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands, Gynecologic Oncology
state: Texas
city: Tyler
country: United States
facility: USO Texas Oncology - Tyler
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Colombia St. Mary's Medical Oncology
state: Wisconsin
city: Pergamino
country: Argentina
facility: Clínica Pergamino S.A.
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion CENIT para la Investigación en Neurociencias - Clinic
state: Ciudad Autonoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Oncología en Ciudad Autónoma de Buenos Aires
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Austral
state: Ciudad Autónoma De Buenos Aire
city: Rosario
country: Argentina
facility: Oncología Médica
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Clínica Caipo
state: Tucumán
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: Córdoba
country: Argentina
facility: Sanatorio del Salvador
city: La Rioja
country: Argentina
facility: Fundación CORI
city: Brisbane
country: Australia
facility: Mater Misericordiae Ltd Mater Cancer Care Centre
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Campbelltown
country: Australia
facility: Macarthur Cancer Therapy
city: Wels
country: Austria
facility: Abteilung für Innere Medizin IV
state: Oberösterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Oberösterreich
city: Leoben
country: Austria
facility: Department für Hämato-Onkologie - LKH Hochsteiermark
state: Steiermark
city: Leoben
country: Austria
facility: Landeskrankenhaus (LKH) Leoben-Eisenerz
state: Steiermark
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
state: Tirol
city: Brasschaat
country: Belgium
facility: AZ Klina
state: Antwerpen
city: Edegem
country: Belgium
facility: UZ Antwerpen - Oncologie
state: Antwerpen
city: Turnhout
country: Belgium
facility: AZ Turnhout
state: Antwerpen
city: Brussels
country: Belgium
facility: Institut Jules Bordet - Oncologie Médicale
state: Brussels Capital Region
city: Brussel
country: Belgium
facility: UZ Brussel - Campus Jette
state: Brussels Capital Region
city: Bruxelles
country: Belgium
facility: CHU Brugmann
state: Brussels Capital Region
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Oncology
state: Brussels Capital Region
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Site Notre-Dame
state: Hainaut
city: Haine-Saint-Paul
country: Belgium
facility: INDC Entité Jolimontoise - CH de Jolimont-Lobbes
state: Hainaut
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne - Site de Libramont
state: Luxembourg
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas - Campus Sint-Niklaas Moerland
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute
state: Vlaams Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan
city: Namur
country: Belgium
facility: CHU UCL Namur - Site Sainte-Elisabeth
city: Namur
country: Belgium
facility: CHU UCL Namur Campus Sainte-Elisabeth
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: East York
country: Canada
facility: Oncology and Haematology Clinic - Michael Garron Hospital
state: Ontario
city: Montreal
country: Canada
facility: Pharmacie du CRCHUM
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Cedars Cancer Center - Oncology
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec - Hopital du Saint Sacrement
city: Vejle
country: Denmark
facility: Vejle Sygehus
state: South Denmark
city: Næstved
country: Denmark
facility: Næstved Sygehus
state: Zeeland
city: Næstved
country: Denmark
facility: Onkologisk Afdeling, Lillebælt Hospital, Vejle
state: Zeeland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Odense
country: Denmark
facility: Odense Universitetshospital - Oncology
city: Strasbourg
country: France
facility: Strasbourg Oncologie Libérale Centre de Radiothérapie
state: Bas-Rhin
city: Caen
country: France
facility: Centre de Lutte Contre le Cancer (CLCC)
state: Calvados
city: Toulouse
country: France
facility: IUCT-Oncopole Pharmacie-Essais Cliniques
state: Haute-Garonne
city: Tours
country: France
facility: Hopital Trousseau - Service d'Oncologie Medicale
state: Indre-et-Loire
city: Lille
country: France
facility: Centre Oscar Lambret, Department de Cancérologie Sénologique
state: Nord
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
state: Puy-de-Dôme
city: Lyon
country: France
facility: Centre Leon Berard Oncologie Médical
state: Rhône
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz Département Pharmacie
state: Rhône
city: Caen
country: France
facility: Centre François Baclesse Service Pharmacie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques
city: Paris
country: France
facility: Centre DeLutte Contre Le Cancer - Institut Curie - Departement d'Oncologie Medica
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques
city: Saint-Cloud
country: France
facility: Institut Curie Saint-Cloud
state: Île-de-France
city: Patra
country: Greece
facility: University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
state: Achaïa
city: Athens
country: Greece
facility: Metropolitan Hospital - Oncology Unit
state: Attiki
city: Larissa
country: Greece
facility: University General Hospital of Larissa
state: Larisa
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Debrecen
country: Hungary
facility: Bács-Kiskun Megyei Kórház
state: Hajdú-Bihar
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
state: Hajdú-Bihar
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
state: Jász-Nagykun-Szolnok
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Onkológiai Központ,
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Cork City
country: Ireland
facility: Bon Secours Hospital [Oncology]
state: Cork
city: Dublin
country: Ireland
facility: Clinical Research Facility, St. James's Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital Cancer Clinical Trials Unit
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Sligo
country: Ireland
facility: Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital
city: Sligo
country: Ireland
facility: Sligo University Hospital
city: Waterford
country: Ireland
facility: Pharmacy, UHW
city: Jerusalem
country: Israel
facility: Sharett Institute of Oncology - Hadassah Medical Center
state: HaMerkaz
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah MO - Oncology
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital - Davidoff Cancer
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center - Oncology
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Meldola
country: Italy
facility: Regional Cancer Center
state: Forli-Cesena
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas Humanitas Cancer Center
state: Milano
city: Monza
country: Italy
facility: Ospedale San Gerardo-ASST Monza
state: Monza E Brianza
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni
city: Cremona
country: Italy
facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
city: Genova
country: Italy
facility: DiMI, Dipartimento di Medicina interna e Specialità mediche,
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena
city: Novara
country: Italy
facility: AOU Maggiore della Carità - SC Oncologia
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Via G. Dottore, 1 Sc Oncologia Medica Azienda Ospedaliera di Perugia
city: Pisa
country: Italy
facility: SO S.Chiara, AOU Pisana - Oncologia 2
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,
city: Roma
country: Italy
facility: Policlinico A. Gemelli
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia de Coimbra
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira - Guimarães, E.P.E.
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto
city: Porto
country: Portugal
facility: Instituto Português Oncologia Francisco Gentil do Porto
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucía
city: La Laguna
country: Spain
facility: Hospital de Dia de Oncología
state: Canarias
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases, Servicio de Oncología
state: Illes Balears
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada. Servicio de Oncología
state: Madrid
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Hospital Xeral Álvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: M.D Anderson Center Madrid
city: Madrid
country: Spain
facility: IOB Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Servicio de Oncología Médica Edificio Materno
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: England
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Maidstone
country: United Kingdom
facility: Kent Oncology Centre, Maidstone Hospital
state: Kent
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Trust
state: Somerset
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre - Oncology
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
Study officials:
References:
citation: 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.
citation: 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.