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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03778931
• Other study ID #: RAD1901-308
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 10, 2019
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Stemline Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 or an aromatase inhibitor (AI) .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 478
• Est. completion date: August 2024
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Elacestrant
400 mg/day once daily oral dosing
• Standard of Care
Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle Anastrozole 1 mg/day on a continuous dosing schedule Letrozole: 2.5 mg/day on a continuous dosing schedule Exemestane: 25 mg/day on a continuous dosing schedule

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stemline Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival in ESR1-mut Subjects	Progression-free Survival based on blinded IRC assessment in ESR1-mut subjects defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Primary	Progression-free Survival in All Subjects	Progression-free Survival based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects	From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Secondary	Overall Survival in ESR1-mut Subjects	Overall Survival in ESR1-mut subjects, where Overall Survival is defined as the length of time from randomization until the date of death from any cause	From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Secondary	Overall Survival in All Subjects	Overall Survival in All (ESR1-mut and ESR1-WT) Subjects	From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)