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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elacestrant
Standard of Care
Sponsored by
Stemline Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Arizona Cancer Center
  • St. Jude Heritage Healthcare
  • Adventist Health Glendale
  • Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)
  • USC IDS Pharmacy
  • Ridley Tree Cancer Center
  • UCLA Hematology/Oncology
  • UCLA West Medical Pharmacy 159
  • TMPN Cancer Care
  • UC Davis Medical Center, Investigational Drug Service
  • US Oncology - Rocky Mountain Cancer Centers - Midtown
  • Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
  • MedStar Washington Hospital Center
  • Moffitt Cancer Center
  • Piedmont Cancer Institute, P.C. - Oncology
  • Suburban Hematology-Oncology Associates
  • Chicago Association for Research and Education in Science
  • Rush University Cancer Center
  • Healthcare Research Network II
  • Norton Cancer Institute
  • Pikeville Medical Center - Oncology/Hematology
  • New England Cancer Specialists
  • Maryland Oncology Hematology,
  • Massachusetts General Hospital Cancer Center
  • Mass General Cancer Center at Newton Wellesley - Oncology
  • Mass General North Shore Cancer Center - Oncology
  • Karmanos Cancer Institute
  • Minnesota Oncology
  • Mayo Clinic
  • Jackson Oncology Associates, PLLC.
  • Precision Cancer Research
  • Saint Barnabas Medical Center - Cancer Center
  • New Mexico Oncology Hematology Consultants - Oncology
  • New Mexico Cancer Care Alliance
  • Montefiore Medical Center
  • New York University Clinical Cancer Center
  • Stony Brook University
  • University Hospitals of Cleveland
  • Oregon Health and Science University
  • Pinnacle Health Cancer Institute
  • Abington Hematology Oncology Associates
  • West Cancer Center
  • Brig Center For Cancer Care And Survivorship
  • Texas Oncology - Central Austin Cancer Center
  • Texas Oncology - Willowbrook
  • US Oncology Research-- Investigational Product Center
  • Texas Oncology - McAllen
  • Cancer Therapy and Research Center at UTHSCSA
  • Texas Oncology - The Woodlands, Gynecologic Oncology
  • USO Texas Oncology - Tyler
  • Utah Cancer Specialists
  • University of Virginia Cancer Center
  • Inova Schar Cancer Institute
  • Fort Belvoir Community Hospital
  • Benaroya Research Institute at Virginia Mason
  • Centro Médico Austral
  • Fundacion CENIT para la Investigación en Neurociencias - Clinic
  • Clínica Universitaria Reina Fabiola
  • Fundación CORI
  • Sunshine Coast University Hospital
  • Macarthur Cancer Therapy
  • St Vincent's Hospital Melbourne
  • Klinikum Wels-Grieskirchen GmbH
  • Landeskrankenhaus (LKH) Leoben-Eisenerz
  • Universitätsklinik Innsbruck
  • AZ Klina
  • UZ Antwerpen - Oncologie
  • AZ Turnhout
  • Institut Jules Bordet - Oncologie Médicale
  • UZ Brussel - Campus Jette
  • CHU Brugmann
  • Cliniques Universitaires Saint-Luc - Oncology
  • Grand Hôpital de Charleroi - Site Notre-Dame
  • INDC Entité Jolimontoise - CH de Jolimont-Lobbes
  • Centre Hospitalier de l'Ardenne - Site de Libramont
  • Onze-Lieve-Vrouwziekenhuis Aalst
  • AZ Nikolaas - Campus Sint-Niklaas Moerland
  • Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute
  • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
  • AZ Groeninge
  • AZ Groeninge - Campus Kennedylaan
  • CHU UCL Namur - Site Sainte-Elisabeth
  • CHU UCL Namur Campus Sainte-Elisabeth
  • Clinique Saint Pierre
  • Pharmacie du CRCHUM
  • McGill University Health Centre - Cedars Cancer Center - Oncology
  • CHU de Quebec - Hopital du Saint Sacrement
  • Vejle Sygehus
  • Næstved Sygehus
  • Aalborg Universitetshospital
  • Odense Universitetshospital - Oncology
  • Centre de Lutte Contre le Cancer (CLCC)
  • Hopital Trousseau - Service d'oncologie médicale
  • Centre Jean Perrin
  • Centre François Baclesse Service Pharmacie
  • Centre Georges Francois Leclerc
  • Hôpital Privé Jean Mermoz Département Pharmacie
  • "Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques"
  • Centre De Lutte Contre Le Cancer - Institut Curie - Département d'Oncologie Médica
  • Hôpital René Huguenin - Institut Curie - Oncologie médicale
  • "Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques"
  • IUCT-Oncopole Pharmacie-Essais Cliniques
  • University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
  • Metropolitan Hospital - Oncology Unit
  • University General Hospital of Larissa
  • Bioclinic Thessaloniki
  • Pécsi Tudományegyetem Klinikai Központ
  • Bács-Kiskun Megyei Kórház
  • Debreceni Egyetem Klinikai Központ
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • Uzsoki Utcai Kórház
  • Semmelweis Egyetem, Onkológiai Központ,
  • Országos Onkológiai Intézet
  • Bon Secours Hospital [Oncology]
  • St Vincent's University Hospital
  • Clinical Research Facility, St. James's Hospital
  • Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital
  • Sligo University Hospital
  • Pharmacy, UHW
  • Shaare Zedek Medical center
  • Hadassah MO - Oncology,Hadassah MO
  • Meir Medical Center
  • Galilee Medical Center
  • Rabin Medical Center - Beilinson Hospital - Davidoff Cancer
  • Tel Aviv Sourasky Medical Center - Oncology
  • The Chaim Sheba Medical Center
  • Assaf Harofeh Medical Center
  • Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni
  • PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
  • DiMI, Dipartimento di Medicina interna e Specialità mediche,
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Azienda Ospedaliero-Universitaria Policlinico di Modena
  • Ospedale San Gerardo-ASST Monza
  • AOU Maggiore della Carità - SC Oncologia
  • Azienda Ospedaliero-Universitaria di Parma
  • IRCCS Policlinico San Matteo
  • SO S.Chiara, AOU Pisana - Oncologia 2
  • Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,
  • Policlinico A. Gemelli
  • Azienda Sanitaria Universitaria Integrata di Udine
  • National Cancer Center
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Instituto Português de Oncologia de Coimbra
  • Hospital Senhora da Oliveira - Guimarães, E.P.E.
  • Hospital da Luz
  • Instituto Português Oncologia Francisco Gentil do Porto
  • Hospital General Universitario de Elche
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitario de Canarias
  • Hospital de Navarra
  • Hospital Xeral Álvaro Cunqueiro
  • Hospital Clinic de Barcelona
  • IOB Ruber Internacional
  • Hospital Clínico San Carlos
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen de la Macarena
  • Hospital Clínico Universitario de Valencia
  • Velindre Cancer Centre - Oncology
  • University College London Hospitals
  • Sarah Cannon Research Institute
  • Taunton and Somerset NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elacestrant

Standard of Care (SoC)

Arm Description

Subjects in Arm 1 will receive elacestrant

Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) in the ESR1-mut subjects
Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects
PFS in all (ESR1-mut and ESR1-WT) subjects
PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects

Secondary Outcome Measures

Objective Survival (OS) in ESR1-mut subjects
OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause
OS in all (ESR1-mut and ESR1-WT) subjects
OS in all (ESR1-mut and ESR1-WT) subjects

Full Information

First Posted
December 3, 2018
Last Updated
July 19, 2022
Sponsor
Stemline Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03778931
Brief Title
Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
Acronym
EMERALD
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemline Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
466 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elacestrant
Arm Type
Experimental
Arm Description
Subjects in Arm 1 will receive elacestrant
Arm Title
Standard of Care (SoC)
Arm Type
Active Comparator
Arm Description
Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Intervention Type
Drug
Intervention Name(s)
Elacestrant
Other Intervention Name(s)
RAD1901
Intervention Description
400 mg/day once daily oral dosing
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Faslodex, Arimidex, Femara, Aromasin
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) in the ESR1-mut subjects
Description
Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects
Time Frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Title
PFS in all (ESR1-mut and ESR1-WT) subjects
Description
PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects
Time Frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Secondary Outcome Measure Information:
Title
Objective Survival (OS) in ESR1-mut subjects
Description
OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause
Time Frame
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Title
OS in all (ESR1-mut and ESR1-WT) subjects
Description
OS in all (ESR1-mut and ESR1-WT) subjects
Time Frame
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Critical Inclusion Criteria: 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. Subjects must be appropriate candidates for endocrine monotherapy Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease 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). Subjects must have ER+/HER2-tumor status 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. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI). Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized. Critical Exclusion Criteria: Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist. Prior anticancer or investigational drug treatment within the following windows: Fulvestrant treatment < 28 days before first dose of study drug Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects) 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 subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor Presence of symptomatic visceral disease as defined in protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Director, Clinical Operations
Organizational Affiliation
Radius Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Adventist Health Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC IDS Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ridley Tree Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA West Medical Pharmacy 159
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
TMPN Cancer Care
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
UC Davis Medical Center, Investigational Drug Service
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
US Oncology - Rocky Mountain Cancer Centers - Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Piedmont Cancer Institute, P.C. - Oncology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Suburban Hematology-Oncology Associates
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Chicago Association for Research and Education in Science
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Rush University Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Healthcare Research Network II
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60487
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Pikeville Medical Center - Oncology/Hematology
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Maryland Oncology Hematology,
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mass General Cancer Center at Newton Wellesley - Oncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Mass General North Shore Cancer Center - Oncology
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minnesota Oncology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Jackson Oncology Associates, PLLC.
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Precision Cancer Research
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Saint Barnabas Medical Center - Cancer Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants - Oncology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York University Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pinnacle Health Cancer Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
Abington Hematology Oncology Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Brig Center For Cancer Care And Survivorship
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Oncology - Central Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Willowbrook
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
US Oncology Research-- Investigational Product Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78053
Country
United States
Facility Name
Cancer Therapy and Research Center at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology - The Woodlands, Gynecologic Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
USO Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Centro Médico Austral
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1019
Country
Argentina
Facility Name
Fundacion CENIT para la Investigación en Neurociencias - Clinic
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1025ABI
Country
Argentina
Facility Name
Clínica Universitaria Reina Fabiola
City
Córdoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Fundación CORI
City
La Rioja
ZIP/Postal Code
5300
Country
Argentina
Facility Name
Sunshine Coast University Hospital
City
Birtinya
ZIP/Postal Code
4575
Country
Australia
Facility Name
Macarthur Cancer Therapy
City
Campbelltown
ZIP/Postal Code
2560
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Landeskrankenhaus (LKH) Leoben-Eisenerz
City
Leoben
State/Province
Steiermark
ZIP/Postal Code
8700
Country
Austria
Facility Name
Universitätsklinik Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
AZ Klina
City
Brasschaat
State/Province
Antwerpen
ZIP/Postal Code
2930
Country
Belgium
Facility Name
UZ Antwerpen - Oncologie
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Turnhout
City
Turnhout
State/Province
Antwerpen
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Institut Jules Bordet - Oncologie Médicale
City
Brussels
State/Province
Brussels Capital Region
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Brussel - Campus Jette
City
Brussel
State/Province
Brussels Capital Region
ZIP/Postal Code
1090
Country
Belgium
Facility Name
CHU Brugmann
City
Bruxelles
State/Province
Brussels Capital Region
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc - Oncology
City
Bruxelles
State/Province
Brussels Capital Region
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hôpital de Charleroi - Site Notre-Dame
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
City
Haine-Saint-Paul
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Centre Hospitalier de l'Ardenne - Site de Libramont
City
Libramont
State/Province
Luxembourg
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Onze-Lieve-Vrouwziekenhuis Aalst
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Nikolaas - Campus Sint-Niklaas Moerland
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
AZ Groeninge - Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU UCL Namur - Site Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
CHU UCL Namur Campus Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Clinique Saint Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Pharmacie du CRCHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1R9
Country
Canada
Facility Name
McGill University Health Centre - Cedars Cancer Center - Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A-3J1
Country
Canada
Facility Name
CHU de Quebec - Hopital du Saint Sacrement
City
Québec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Vejle Sygehus
City
Vejle
State/Province
South Denmark
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Næstved Sygehus
City
Næstved
State/Province
Zeeland
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Odense Universitetshospital - Oncology
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Centre de Lutte Contre le Cancer (CLCC)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Hopital Trousseau - Service d'oncologie médicale
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63011
Country
France
Facility Name
Centre François Baclesse Service Pharmacie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Privé Jean Mermoz Département Pharmacie
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
"Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques"
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre De Lutte Contre Le Cancer - Institut Curie - Département d'Oncologie Médica
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital René Huguenin - Institut Curie - Oncologie médicale
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
"Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques"
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
IUCT-Oncopole Pharmacie-Essais Cliniques
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
City
Patra
State/Province
Achaïa
ZIP/Postal Code
26504
Country
Greece
Facility Name
Metropolitan Hospital - Oncology Unit
City
Athens
State/Province
Attiki
ZIP/Postal Code
18547
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
State/Province
Larisa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Bioclinic Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Bács-Kiskun Megyei Kórház
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
7032
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
City
Szolnok
State/Province
Jász-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
City
Nyiregyhaza
State/Province
Szabolcs-Szatmár-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Uzsoki Utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Semmelweis Egyetem, Onkológiai Központ,
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Bon Secours Hospital [Oncology]
City
Cork City
Country
Ireland
Facility Name
St Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Clinical Research Facility, St. James's Hospital
City
Sligo
ZIP/Postal Code
F91 H684
Country
Ireland
Facility Name
Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital
City
Sligo
ZIP/Postal Code
F91 H684
Country
Ireland
Facility Name
Sligo University Hospital
City
Sligo
ZIP/Postal Code
F91 H684
Country
Ireland
Facility Name
Pharmacy, UHW
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Shaare Zedek Medical center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah MO - Oncology,Hadassah MO
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital - Davidoff Cancer
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center - Oncology
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
DiMI, Dipartimento di Medicina interna e Specialità mediche,
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Ospedale San Gerardo-ASST Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
AOU Maggiore della Carità - SC Oncologia
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
SO S.Chiara, AOU Pisana - Oncologia 2
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Policlinico A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Integrata di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Instituto Português de Oncologia de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Senhora da Oliveira - Guimarães, E.P.E.
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Instituto Português Oncologia Francisco Gentil do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
State/Province
Canarias
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Xeral Álvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
IOB Ruber Internacional
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Velindre Cancer Centre - Oncology
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Trust
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35584336
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. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3962.
Results Reference
derived
PubMed Identifier
31426673
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.
Results Reference
derived

Learn more about this trial

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

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