Clinical trial NCT06492616: A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Official title: Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: ELEGANT
Breast Cancer Stage II
Breast Cancer Stage III
Breast Cancer Female
Breast Cancer, Male
High-Risk Breast Cancer
High Risk Breast Carcinoma
ER-positive Breast Cancer
ER-positive HER-2 Negative Breast Cancer
ER Positive/HER2 Low Breast Cancer
Breast Cancer, ER+, HER2-
Adjuvant
Adjuvant Therapy
Lead sponsor: Stemline Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 4220
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: The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.


Eligibility criteria: Key Inclusion Criteria:

* Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0 or 1, or (IHC = 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Participants considered at high risk of recurrence at initial staging
* Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
* Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Key Exclusion Criteria:

* Participants with inflammatory breast cancer
* History of any prior (ipsilateral and/or contralateral) invasive breast cancer
* Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
* Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Invasive Breast Cancer-Free Survival (IBCFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Distant Relapse-Free Survival (DRFS)
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Invasive Disease-Free Survival (IDFS)
timeFrame: Up to 5 years
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 5 years plus 28 days
measure: Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
measure: Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
timeFrame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
measure: Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)
timeFrame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
measure: Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)
timeFrame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
measure: Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
timeFrame: Predose up to 4 hours postdose
measure: Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
timeFrame: Predose up to 4 hours postdose
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Research Center, LLC
state: California
city: Los Angeles
country: United States
facility: UCLA Department of Medicine - Hematology/Oncology
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Sacramento
country: United States
facility: Dignity Health dba Health Research Institute
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Francisco
country: United States
facility: Helen Diller Family Comprehensive Cancer Center
state: California
city: Solvang
country: United States
facility: Sansum Clinic
state: California
city: Denver
country: United States
facility: St.Joseph Hospital- Cancer Centers of Colorado
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Parker
country: United States
facility: AHMG Hematology and Oncology
state: Colorado
city: Westminster
country: United States
facility: Cancer Care at CommonSpirit St. Anthony North Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital- Yale Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando Infusion Center
state: Florida
city: Palm Bay
country: United States
facility: Cancer Care Centers of Brevard (CCCB) - Palm Bay
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Healthcare System
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Athens
country: United States
facility: University Blood & Cancer Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii Moanalua Medical Center
state: Hawaii
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Dyer
country: United States
facility: Northwest Cancer Centers, PC
state: Indiana
city: Des Moines
country: United States
facility: Mission Cancer and Blood
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Ascension St. Agnes Hospital
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: The Cancer & Hematology Centers
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health Cancer Institute - Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Lincoln
country: United States
facility: NHO Revive Research Institute LLC
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
state: Nebraska
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Ctr-Hackensack UMC
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd.
state: New Mexico
city: Ithaca
country: United States
facility: Cayuga Medical Center
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Fayetteville
country: United States
facility: Cape Fear Valley Medical Center
state: North Carolina
city: Centerville
country: United States
facility: Miami Valley Hospital South
state: Ohio
city: Fairfield
country: United States
facility: Oncology_Hematology Care Clinical Trials, LLC
state: Ohio
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Broomall
country: United States
facility: Consultants In Medical Oncology and Hematology, P.C.
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Media
country: United States
facility: Alliance Cancer Specialists, PC
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Henry - Joyce Cancer Clinic
state: Tennessee
city: Abilene
country: United States
facility: Hendrick Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - DFW
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: New Braunfels
country: United States
facility: Texas Oncology - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology- Central South
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Wytheville
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center- University Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: UW Cancer Center at ProHealth Care
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Gateshead
country: Australia
facility: Lake Macquarie Private Hospital - Oncology
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base Hospital - Cancer Care , Haematology Unit
state: New South Wales
city: North Sydney
country: Australia
facility: Mater Hospital Sydney
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Hyde Park
country: Australia
facility: Icon Cancer Centre Townsville
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Centre Southport
state: Queensland
city: Auchenflower
country: Australia
facility: Icon Cancer Centre Wesley
state: Quuensland
city: Kurralta Park
country: Australia
facility: Icon Cancer Centre Kurralta Park
state: South Australia
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Nedlands
country: Australia
facility: Breast Cancer Research Centre
state: Western Australia
city: Hobart
country: Australia
facility: Icon Cancer Centre Hobart
city: Port Macquarie
country: Australia
facility: Mid North Coast Cancer Institute
city: Wien
country: Austria
facility: Hanusch Krankenhaus
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi - Site Les Viviers
state: Hainaut
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
state: Limburg
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Saint-Jerome
country: Canada
facility: Regional Hospital Saint-Jerome
state: Quebec
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav - Klinika komplexni onkol. pece
state: Brno-město
city: Praha 10
country: Czechia
facility: FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice - Onkologicka klinika
city: Besancon
country: France
facility: Centre Hospitalier Regional et Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz
state: Alpes-Maritimes
city: St. Herblain
country: France
facility: Institut de Cancerologie de l'Ouest - Oncology
state: Loire-Atlantique
city: Bezannes
country: France
facility: ICONE
state: Marne
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine
state: Vaucluse
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire De Poitiers - Pôle Régional de Cancérologie
city: Vandœuvre-Lès-Nancy Cedex 03
country: France
facility: Institut de Cancérologie de Lorraine
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim (UMM)
state: Baden-Württemberg
city: Eggenfelden
country: Germany
facility: Studienzentrale für das MVZ e.K
state: Bayern
city: Rüdersdorf
country: Germany
facility: Immanuel Klinik Rüdersdorf
state: Brandenburg
city: Esslingen am Neckar
country: Germany
facility: 'Klinikum Esslingen GmbH
state: Esslingen a.N.
city: Brandenburg
country: Germany
facility: 'Schwerpunktpraxis Fuer Gynaekologie und Onkologie
state: Fuerstenwalde /Spree
city: Worms
country: Germany
facility: Klinikum Worms gGmbH
state: Rheinland-Pfalz
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Varmegyei Oktatakorhaz
state: Bács-Kiskun
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
state: Hajdú-Bihar
city: Salgótarján
country: Hungary
facility: Nograd Varmegyei Szent Lazar Korhaz
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Korhaz
city: Meldola
country: Italy
facility: IRST Dino Amadori IRCCS
state: Forli-Cesena
city: Monza
country: Italy
facility: IRCCS San Gerardo dei Tintori
state: Monza E Brianza
city: Frattamaggiore
country: Italy
facility: Azienda Sanitaria Locale Napoli 2 Nord
state: Napoli
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico, IRCCS
state: Pordenone
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferen IRCCS, Opera di San Pio da Pietrelcina
state: Puglia
city: Firenze
country: Italy
facility: SOD Radioterapia Oncologica, AOU Careggi
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori,IRCCS
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale
city: Prato
country: Italy
facility: Azienda USL Toscana Centro
city: Rimini
country: Italy
facility: Azienda Unita Sanitaria Locale della Romagna
city: Rionero In Vulture
country: Italy
facility: Irccs Crob
city: Roma
country: Italy
facility: Fondazione PU Campus Biomedico
city: Roma
country: Italy
facility: U.O. Ginecologia Oncologica - Fondazione Policlinico A. Gemelli
city: Roma
country: Italy
facility: IRCCS Istituto Nazionale Tumori Regina Elena,UOSD Sperimentazioni di fase IV
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria Di Sassari
city: Verona
country: Italy
facility: Ospedale Sacro cuore Don Calabria- Negrar di Valpolicella
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbugdo [Ch'ungch'ongbuk-do]
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon Gwang'yeogsi [Inch'n-Kwangyokshi]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital - Oncology
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang - Rheumatology
state: Pulau Pinang
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: UKM Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Beacon Hospital
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
state: Wilayah Persekutuan
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
state: Wilayah Persekutuan
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Melaka
country: Malaysia
facility: Mahkota Medical Center
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Łódź
country: Poland
facility: IP Clinic Sp. z o.o.
state: Lodz
city: Poznan
country: Poland
facility: Pratia Poznan
state: Wielkopolskie
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo. Hospital de Loures - Oncologia Medica
state: Lisboa
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
city: Setúbal
country: Portugal
facility: Unidade Local de Saúde de Arrábida
city: Craiova
country: Romania
facility: Oncolab - Medical Oncology
state: Dolj
city: Craiova
country: Romania
facility: Centrul de Oncologie Sf. Nectarie
state: Dolj
city: Bucuresti
country: Romania
facility: Spitalul Clinic Filantropia
city: Bucuresti
country: Romania
facility: Spitalul Clinic CF Nr 2 Bucuresti
city: Bucuresti
country: Romania
facility: Memorial Healthcare International
city: Floreşti
country: Romania
facility: Radiotherapy Center Cluj
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: A Coruña
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
state: Andalucia
city: Sevilla
country: Spain
facility: H. Virgen de Valme
state: Andalucia
city: San Cristobal de la Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen De La Arrixaca
state: Murcia
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Las Palmas De Gran Canaria
country: Spain
facility: H.U. Insular Gran Canaria
city: Lleida
country: Spain
facility: H.U Arnau De Vilanova Lleida
city: Madrid
country: Spain
facility: Hospital Beata Maria Ana
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena - Oncología Médica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia
city: Valencia
country: Spain
facility: Hospital Quironsalud Valencia
city: Aarau
country: Switzerland
facility: Tumor Zentrum Aarau
state: Aargau (de)
city: Zürich
country: Switzerland
facility: Brust-Zentrum AG Zurich
state: Zürich (de)
city: Schaffhausen
country: Switzerland
facility: Spitaeler Schaffhausen Kantonspital
city: Changhua City
country: Taiwan
facility: Changhua Christian Medical Foundation Changhua Christian Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital (RCH) - Sunrise Centre
state: Cornwall
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital Kent Oncology Centre
Study officials:
affiliation: Stemline Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: