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

Who is this study for? Patients with Breast Cancer
Status: Completed
Location: See all (244) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.

• Participants must be appropriate candidates for endocrine monotherapy

• Participants must have measurable disease or bone only disease with evaluable lesions

• Female or male participants age ≥ 18 years; female participants must be postmenopausal women, and male participants must not allow pregnancy with their sperm (abstain, do not donate sperm, et cetera).

• Participants must have ER+ and HER2- tumor status

• Participants must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.

• Participants must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI) for advanced/metastatic breast cancer (mBC).

• Participants may have received no more than one line of chemotherapy in the advanced/metastatic setting.

Locations
United States
Arkansas
St Bernard's Cancer Care
Jonesboro
Arizona
The University of Arizona Cancer Center
Tucson
California
St. Jude Heritage Healthcare
Fullerton
Adventist Health Glendale
Glendale
Moores Cancer Center at UC San Diego Health
La Jolla
Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)
Los Angeles
Keck Medical Center of USC
Los Angeles
UCLA Hematology/Oncology
Los Angeles
UCLA West Medical Pharmacy 159
Los Angeles
USC IDS Pharmacy
Los Angeles
TMPN Cancer Care
Redondo Beach
UC Davis Medical Center, Investigational Drug Service
Sacramento
UCSF Medical Center
San Francisco
Ridley-Tree Cancer Center
Santa Barbara
Colorado
Anschutz Cancer Center Pavilion
Aurora
US Oncology - Rocky Mountain Cancer Centers - Midtown
Denver
Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
Fort Collins
UCHealth Cancer Center
Fort Collins
Connecticut
Yale Cancer Center
New Haven
Washington, D.c.
MedStar Washington Hospital Center
Washington D.c.
Florida
Orlando Health Cancer Institute
Orlando
Moffitt Cancer Center
Tampa
Georgia
Piedmont Cancer Institute, P.C. - Oncology
Atlanta
Suburban Hematology-Oncology Associates
Lawrenceville
Northwest Georgia Oncology Centers
Marietta
Illinois
Chicago Association for Research and Education in Science
Chicago
Rush University Cancer Center
Chicago
Cancer Care Center of Decatur
Decatur
Joliet Oncology-Hematology Associates
Joliet
Presence Medical Group Hematology Oncology
Skokie
Simmons Cancer Institute
Springfield
Healthcare Research Network II
Tinley Park
Indiana
Fort Wayne Medical Oncology And Hematology
Fort Wayne
Goshen Center for Cancer Care
Goshen
Hematology Oncology Of Indiana
Indianapolis
Cancer Resource Centre
Munster
Kansas
University of Kansas Cancer Center
Westwood
Kentucky
Norton Cancer Institute
Louisville
Pikeville Medical Center - Oncology/Hematology
Pikeville
Louisiana
Ochsner Medical Center
New Orleans
Highland Clinic
Shreveport
Massachusetts
Boston Medical Center
Boston
Mass General Cancer Center at Newton Wellesley - Oncology
Boston
Massachusetts General Hospital Cancer Center
Boston
Mass General North Shore Cancer Center - Oncology
Danvers
Maryland
The Gynecologic Oncology Center at Mercy
Baltimore
Weinberg Cancer Institute at Franklin Square
Baltimore
Maryland Oncology Hematology
Frederick
Maine
New England Cancer Specialists
Scarborough
Michigan
Karmanos Cancer Institute
Detroit
Minnesota
Minnesota Oncology
Minneapolis
Mayo Clinic
Rochester
Missouri
Chub O'Reilly Cancer Center
Springfield
Mississippi
Jackson Oncology Associates, PLLC.
Jackson
North Carolina
Carolina Institute For Clinical Research
Fayetteville
Nebraska
The Fred & Pamela Buffett Cancer Center
Omaha
New Jersey
Precision Cancer Research
Freehold
Saint Barnabas Medical Center - Cancer Center
Livingston
The Steeplechase Cancer Center
Somerville
New Mexico
New Mexico Cancer Care Alliance
Albuquerque
New Mexico Oncology Hematology Consultants - Oncology
Albuquerque
New York
New York Oncology Hematology
Albany
Northern Westchester Hospital Cancer Center
Mount Kisco
New York University Clinical Cancer Center
New York
Stony Brook University
Stony Brook
Montefiore Medical Center
The Bronx
Oncology and Hematology of White Plains
White Plains
Ohio
US Oncology Network
Cincinnati
University Hospitals of Cleveland
Cleveland
Dayton Oncology & Hematology
Kettering
Toledo Clinic Cancer Center
Toledo
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Gettysburg Cancer Center
Gettysburg
Pinnacle Health Cancer Institute
Harrisburg
Abington Hematology Oncology Associates
Willow Grove
Lankenau Medical Center
Wynnewood
South Carolina
Charleston Oncology
Charleston
MUSC Hollings Cancer Center
Charleston
Tennessee
West Cancer Center
Germantown
Brig Center For Cancer Care And Survivorship
Knoxville
Texas
Austin Cancer Centers
Austin
Elligo Health Research
Austin
Texas Oncology - Central Austin Cancer Center
Austin
Texas Oncology-Beaumont
Beaumont
Texas Oncology-Medical City Dallas
Dallas
Texas Oncology-Methodist Dallas Cancer Center
Dallas
Texas Oncology-Presbyterian Cancer Center Dallas
Dallas
Texas Oncology - Willowbrook
Houston
Texas Oncology - McAllen
Mcallen
Texas Oncology-Mesquite
Mesquite
Texas Oncology-Paris
Paris
Texas Oncology-Plano East
Plano
Texas Oncology-Plano West
Plano
Cancer Therapy and Research Center at UTHSCSA
San Antonio
Renovatio Medical The Woodlands
The Woodlands
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands
USO Texas Oncology - Tyler
Tyler
Utah
Utah Cancer Specialists
Salt Lake City
Virginia
University of Virginia Cancer Center
Charlottesville
Inova Schar Cancer Institute
Fairfax
Fort Belvoir Community Hospital
Fort Belvoir
Washington
Benaroya Research Institute at Virginia Mason
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center
Madison
Colombia St. Mary's Medical Oncology
Milwaukee
Other Locations
Argentina
Centro Médico Austral
Buenos Aires
Fundacion CENIT para la Investigación en Neurociencias - Clinic
Buenos Aires
Oncología en Ciudad Autónoma de Buenos Aires
Buenos Aires
Clínica Universitaria Reina Fabiola
Córdoba
Sanatorio del Salvador
Córdoba
Fundación CORI
La Rioja
Clínica Pergamino S.A.
Pergamino
Oncología Médica
Rosario
Clínica Caipo
San Miguel De Tucumán
Australia
Sunshine Coast University Hospital
Birtinya
Mater Misericordiae Ltd Mater Cancer Care Centre
Brisbane
Macarthur Cancer Therapy
Campbelltown
St Vincent's Hospital Melbourne
Fitzroy
Austria
Universitätsklinik Innsbruck
Innsbruck
Department für Hämato-Onkologie - LKH Hochsteiermark
Leoben
Landeskrankenhaus (LKH) Leoben-Eisenerz
Leoben
Abteilung für Innere Medizin IV
Wels
Klinikum Wels-Grieskirchen GmbH
Wels
Belgium
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst
AZ Klina
Brasschaat
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
Bruges
CHU Brugmann
Brussels
Cliniques Universitaires Saint-Luc - Oncology
Brussels
Institut Jules Bordet - Oncologie Médicale
Brussels
UZ Brussel - Campus Jette
Brussels
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi
UZ Antwerpen - Oncologie
Edegem
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
Haine-saint-paul
AZ Groeninge
Kortrijk
AZ Groeninge - Campus Kennedylaan
Kortrijk
Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute
Leuven
Centre Hospitalier de l'Ardenne - Site de Libramont
Libramont
CHU UCL Namur - Site Sainte-Elisabeth
Namur
CHU UCL Namur Campus Sainte-Elisabeth
Namur
Clinique Saint Pierre
Ottignies
AZ Nikolaas - Campus Sint-Niklaas Moerland
Sint-niklaas
AZ Turnhout
Turnhout
Canada
Oncology and Haematology Clinic - Michael Garron Hospital
East York
McGill University Health Centre - Cedars Cancer Center - Oncology
Montreal
Pharmacie du CRCHUM
Montreal
CHU de Quebec - Hopital du Saint Sacrement
Québec
Denmark
Aalborg Universitetshospital
Aalborg
Næstved Sygehus
Næstved
Onkologisk Afdeling, Lillebælt Hospital, Vejle
Næstved
Odense Universitetshospital - Oncology
Odense
Vejle Sygehus
Vejle
France
Centre de Lutte Contre le Cancer (CLCC)
Caen
Centre François Baclesse Service Pharmacie
Caen
Centre Jean Perrin
Clermont-ferrand
Centre Georges Francois Leclerc
Dijon
Centre Oscar Lambret, Department de Cancérologie Sénologique
Lille
Centre Leon Berard Oncologie Médical
Lyon
Hôpital Privé Jean Mermoz Département Pharmacie
Lyon
Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques
Montpellier
Centre DeLutte Contre Le Cancer - Institut Curie - Departement d'Oncologie Medica
Paris
Institut Curie Saint-Cloud
Saint-cloud
Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques
Saint-priest-en-jarez
Strasbourg Oncologie Libérale Centre de Radiothérapie
Strasbourg
IUCT-Oncopole Pharmacie-Essais Cliniques
Toulouse
Hopital Trousseau - Service d'Oncologie Medicale
Tours
Greece
Metropolitan Hospital - Oncology Unit
Athens
University General Hospital of Larissa
Larissa
University General Hospital Of Patras - Dpt Of Medicine, Division Oncology
Pátrai
Bioclinic Thessaloniki
Thessaloniki
Hungary
Országos Onkológiai Intézet
Budapest
Semmelweis Egyetem, Onkológiai Központ,
Budapest
Uzsoki Utcai Kórház
Budapest
Bács-Kiskun Megyei Kórház
Debrecen
Debreceni Egyetem Klinikai Központ
Debrecen
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza
Pécsi Tudományegyetem Klinikai Központ
Pécs
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
Szolnok
Ireland
Bon Secours Hospital [Oncology]
Cork
Beaumont Hospital Cancer Clinical Trials Unit
Dublin
Clinical Research Facility, St. James's Hospital
Dublin
St Vincent's University Hospital
Dublin
Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital
Sligo
Sligo University Hospital
Sligo
Pharmacy, UHW
Waterford
Israel
Hadassah MO - Oncology
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Sharett Institute of Oncology - Hadassah Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
Galilee Medical Center
Nahariya
Rabin Medical Center - Beilinson Hospital - Davidoff Cancer
Petah Tikva
Tel Aviv Sourasky Medical Center - Oncology
Tel Aviv
The Chaim Sheba Medical Center
Tel-hashomer
Assaf Harofeh Medical Center
Ẕerifin
Italy
Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni
Bologna
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
Cremona
DiMI, Dipartimento di Medicina interna e Specialità mediche,
Genova
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Regional Cancer Center
Meldola
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena
Ospedale San Gerardo-ASST Monza
Monza
AOU Maggiore della Carità - SC Oncologia
Novara
Azienda Ospedaliero-Universitaria di Parma
Parma
IRCCS Policlinico San Matteo
Pavia
Via G. Dottore, 1 Sc Oncologia Medica Azienda Ospedaliera di Perugia
Perugia
SO S.Chiara, AOU Pisana - Oncologia 2
Pisa
Policlinico A. Gemelli
Roma
Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,
Roma
IRCCS Istituto Clinico Humanitas Humanitas Cancer Center
Rozzano
Azienda Sanitaria Universitaria Integrata di Udine
Udine
Portugal
Instituto Português de Oncologia de Coimbra
Coimbra
Hospital Senhora da Oliveira - Guimarães, E.P.E.
Guimarães
Hospital da Luz
Lisbon
Instituto Português de Oncologia do Porto
Porto
Instituto Português Oncologia Francisco Gentil do Porto
Porto
Republic of Korea
National Cancer Center
Goyang
Gachon University Gil Medical Center
Incheon
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Spain
Hospital Clinic de Barcelona
Barcelona
Hospital General Universitario de Elche
Elche
Hospital Universitario de Fuenlabrada. Servicio de Oncología
Fuenlabrada
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Paz
Madrid
IOB Ruber Internacional
Madrid
M.D Anderson Center Madrid
Madrid
Servicio de Oncología Médica Edificio Materno
Madrid
Hospital Universitario Son Espases, Servicio de Oncología
Palma De Mallorca
Hospital de Navarra
Pamplona
Hospital de Dia de Oncología
San Cristóbal De La Laguna
Hospital Universitario de Canarias
Santa Cruz De Tenerife
Hospital Universitario Virgen de la Macarena
Seville
Hospital Universitario Virgen del Rocio
Seville
Hospital Clínico Universitario de Valencia
Valencia
Hospital Xeral Álvaro Cunqueiro
Vigo
United Kingdom
Velindre Cancer Centre - Oncology
Cardiff
Sarah Cannon Research Institute
London
University College London Hospitals
London
Kent Oncology Centre, Maidstone Hospital
Maidstone
Mount Vernon Cancer Centre
Northwood
University Hospital Southampton NHS Foundation Trust
Southampton
Taunton and Somerset NHS Trust
Taunton
Time Frame
Start Date: 2019-05-10
Completion Date: 2024-08-22
Participants
Target number of participants: 478
Treatments
Experimental: Elacestrant
Participants in Arm 1 will receive elacestrant.
Active_comparator: Standard of Care (SoC)
Participants in Arm 2 will receive investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane).
Authors
Jose Batista, Nandini Ignatius, Mohamad Kassar, Pramvir Verma, Kirtan Koticha, debra patt, Alvaro Restrepo, Peter Kabos, Michael John Martin, Christopher Stokoe, Ira Oliff, William Lawler, Jonathan Goldberg, Varsha Shah, Karthik Giridhar, Paul Gilman, Sadaf Taimur, Dan Costin, Ursa Brown-Glaberman, Kerin Adelson, Anneliese Gonzalez, Rex Mowat, Subramanya Rao, Patrick Dillon, David Riseberg, Karen Tedesco, Shruti Tiwari, Mihran Shirinian, Tracey Weisberg, Kathleen Harnden, Paula Ryan, Thomas Cosgriff, Regan Rostorfer, Melody Cobleigh, Hadeel Assad, Satish Shah, David Ellison, Philip Kovoor, Sara Robinson, Kit Lu, Manuel Ruiz Borrego, Raymond Brig, Christopher Croot, Anna Litvak, Jeffrey Hargis, Conleth Murphy, Gregory Vidal, Jay Courtright, Daniel Bruetman, Suzanne Partridge, Bobby Graham, Kristi McIntyre, Yelena Novik, Zahi Mitri, Shiela Haffar, Nafisa Burhani, Aditya Bardia, Meaghan O'Malley, David Chen, Michaela Tsai, Sucharu Prakash, Sunil Babu, Atisha Manhas, Helen Chew, Clara Lee, Aldemar Montero, Sridhar Bolla, Paula Silverman, Joseph Potz, Henna Malik, Virginia Kaklamani, Frank Priou, Karen McAdam, Fharat Raja, Florence Dalenc, Christelle LEVY, Audrey Hennequin, Joseph Sparano, John Cole, Rebecca Jaslow, Alison Stopeck, Pavani Chalasani, Mazen Khalil, Mary Crow, Bethany Sleckman, Diana Medgyesy, Sara Hurvitz, Herbert Stöger, Evangelia Razis, Jeanette Jensen, Georgeta Fried, Michael Thirlwell, Christoph Tinchon, Simon Waters, Elisa Ferraris, Begoña Bermejo de las Heras, Joo Hyuk Sohn, Fausto Roila, Pilar Zamora Auñón, Iryna Kuchuk, Daniela Katz, Didier Verhoeven, Jean-Philippe Jacquin, Ines Deleu, Noémia Afonso, Duncan Wheatley, Vesna Glavicic, Susana Sousa, Haralabos Kalofonos, Louise Nott, Mauro Mansutti, Michelle Morris, Florentia Peintinger, Magdolna Dank, Janice Walshe, Antonino Musolino, Amir Sonnenblick, Tamar Peretz-Yablonski, Claudio Zamagni, Danielle Charpentier, Christel Fontaine, Giuseppe Tonini, José Illarramendi, Diego Kaen, Karoly Mahr, Rinat Yerushalmi, Shani Paluch-Shimon, Athanasios Kotsakis, Tibor Csoszi, Alessandra Gennari, Laszlo Landherr, Marie-Ange Mouret-Reynier, Dominique Boudreau, Daniel Egle, Alberto Ballestrero, Laura Cortesi, Judit Kocsis, Helena Linardou, Ido Wolf, Ioannis Boukovinas, Ernesto Korbenfeld, Donatienne Taylor, Seock-ah Im, Gabor Rubovszky, Frédéric Forget, Patrick Neven, Belinda Kiely, Peter Vuylsteke, Daniele Generali, Hee Kyung Ahn, Philippe Aftimos, Peter Arkosy, Melissa Moore, OLFA DERBEL, László Mangel, Wiebren Tjalma, Monica Nave, Ayelet Shai, Andrea Rocca, Jean-Luc Canon, Séverine GUIU, Emilio Bria, Marina Cazzaniga, Seamus O'Reilly, Francois Duhoux, Erik Jakobsen
Related Therapeutic Areas
Sponsors
Leads: Stemline Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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