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Trial Title: Evaluation of Lasofoxifene Combined with Abemaciclib Compared with Fulvestrant Combined with Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation

NCT ID: NCT05696626

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Fulvestrant

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: open label, randomized, parallel-group, multicenter study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Lasofoxifene in combination with abemaciclib
Description: 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day
Arm group label: Treatment

Intervention type: Drug
Intervention name: Fulvestrant in combination with abemaciclib
Description: Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day
Arm group label: Reference Therapy

Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Pre- or postmenopausal women or men. 2. Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease. 3. Histological or cytological confirmation of ER+/HER2 - disease 4. No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer. 5. At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue. 6. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions. 7. Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy. 8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 9. Adequate organ function 10. Able to swallow tablets 11. Brain metastases are allowed only if the following 4 parameters hold: 1. Asymptomatic, 2. Definitively treated (e.g., radiotherapy, surgery), 3. Not requiring steroids up to 4 weeks before study treatment initiation, AND 4. Central nervous system disease stable for >3 months prior to registration as documented by magnetic resonance imagining (MRI). 12. Able to understand and voluntarily sign a written informed consent before any screening procedures. Exclusion Criteria: 1. Lymphangitic carcinomatosis involving the lung. 2. History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy. 3. Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator. 4. Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy. 5. Subjects with a known hypersensitivity to fulvestrant or to any of the excipients 6. Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1). 7. Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.) 8. History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of >480 msec. 9. History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia. 10. Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure [CHF] or prolonged immobilization). 11. On concomitant strong CYP3A4 inhibitors. 12. On strong and moderate CYP3A4 inducers. 13. Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption. 14. Active systemic bacterial or fungal infection (requiring intravenous [IV] antibiotics or antifungals at the time of initiating study treatment). 15. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). 16. History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery. 17. Positive serum pregnancy test (only if premenopausal). 18. Sexually active premenopausal women and men unwilling to use double-barrier contraception. 19. Women who are breast feeding 20. History of non-compliance to medical regimens. 21. Unwilling or unable to comply with the protocol. 22. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic - Phoenix

Address:
City: Phoenix
Zip: 85054
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Office - All Mayo Clinic Locations

Phone: 855-776-0015

Facility:
Name: University of Arizona - Cancer Center

Address:
City: Tucson
Zip: 85719
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer Segar

Phone: 520-626-8096
Email: segar@arizona.edu

Facility:
Name: California Research Institute

Address:
City: Los Angeles
Zip: 90027
Country: United States

Status: Recruiting

Contact:
Last name: Ghassan Al-Jazayrly
Email: pi@caresinst.com

Facility:
Name: Providence Medical Foundation - Santa Rosa, CA

Address:
City: Santa Rosa
Zip: 95403
Country: United States

Status: Recruiting

Contact:
Last name: Jarrod Holmes
Email: jarrod.holmes@stjoe.org

Facility:
Name: Boca Raton Regional Hospital

Address:
City: Boca Raton
Zip: 33486
Country: United States

Status: Recruiting

Contact:
Last name: Angelina The
Email: athe@baptisthealth.net

Facility:
Name: Mayo Clinic - Jacksonville

Address:
City: Jacksonville
Zip: 32224
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Office - All Mayo Clinic Locations

Phone: 855-776-0015

Facility:
Name: Miami Cancer Institute

Address:
City: Miami
Zip: 33143
Country: United States

Status: Recruiting

Contact:
Last name: Grace Wang
Email: gracew@baptisthealth.net

Facility:
Name: Miami Cancer Institute Plantation

Address:
City: Plantation
Zip: 33324
Country: United States

Status: Recruiting

Contact:
Last name: Grace Wang
Email: gracew@baptisthealth.net

Facility:
Name: Emory University School of Medicine

Address:
City: Atlanta
Zip: 30322
Country: United States

Status: Recruiting

Contact:
Last name: Jane Meisel
Email: jane.l.meisel@emory.edu

Facility:
Name: Norton Cancer Institute

Address:
City: Louisville
Zip: 40202
Country: United States

Status: Recruiting

Contact:
Last name: Laila Agrawal
Email: laila.agrawal@nortonhealthcare.org

Facility:
Name: Hematology Oncology Clinic

Address:
City: Baton Rouge
Zip: 70809
Country: United States

Status: Recruiting

Contact:
Last name: Gerald Miletello
Email: Gerald.miletello@aoncology.com

Facility:
Name: Johns Hopkins Kimmel Cancer Center

Address:
City: Baltimore
Zip: 21231
Country: United States

Status: Recruiting

Contact:
Last name: Jessica Tao
Email: jtao10@jhmi.edu

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Status: Recruiting

Contact:
Last name: Seth Wander
Email: SWANDER@mgh.harvard.edu

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02115
Country: United States

Status: Recruiting

Contact:
Last name: Sarah Sammons
Email: sarahl_sammons@dfci.harvard.edu

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: S Berwick
Email: sberwick@bidmc.harvard.edu

Facility:
Name: Cancer and Hematology Centers of Western Michigan

Address:
City: Grand Rapids
Zip: 49503
Country: United States

Status: Recruiting

Contact:
Last name: Amy Vander Woude
Email: avanderwoude@gmail.com

Facility:
Name: Allina Health System DBA Virginia Piper Cancer Institute

Address:
City: Minneapolis
Zip: 55407
Country: United States

Status: Not yet recruiting

Contact:
Last name: Perez Domingo
Email: domingo.perez@allina.com

Facility:
Name: Mayo Clinic - Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Office - All Mayo Clinic Locations

Phone: 855-776-0015

Facility:
Name: Saint Luke's Cancer Institute

Address:
City: Kansas City
Zip: 64111
Country: United States

Status: Recruiting

Contact:
Last name: Timothy Pluard

Phone: 816-932-3300
Email: tpluard@saint-lukes.org

Facility:
Name: Washington University School of Medicine

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Nusayba Bagegni
Email: nbagegni@wustl.edu

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Status: Suspended

Facility:
Name: Renown Regional Medical Centre

Address:
City: Reno
Zip: 89502
Country: United States

Status: Not yet recruiting

Contact:
Last name: Lee Schwartzberg
Email: Lee.Schwartzberg@renown.org

Facility:
Name: New Jersey Cancer Care, PA

Address:
City: Belleville
Zip: 07109
Country: United States

Status: Not yet recruiting

Contact:
Last name: James Orsini

Phone: 973-751-8880

Phone ext: 269
Email: jmo@njcancercare.com

Facility:
Name: Icahn School of Medicine at Mount Sinai

Address:
City: New York
Zip: 10029
Country: United States

Status: Recruiting

Contact:
Last name: Amy Tiersten
Email: amy.tiersten@mssm.edu

Facility:
Name: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Sherry Shen
Email: shens1@mskcc.org

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27705
Country: United States

Status: Recruiting

Contact:
Last name: Carey Anders

Phone: 919-660-1278
Email: carey.anders@duke.edu

Facility:
Name: Altru Health Systems

Address:
City: Grand Forks
Zip: 58201
Country: United States

Status: Recruiting

Contact:
Last name: Grant Seeger
Email: gseeger@altru.org

Facility:
Name: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

Address:
City: Columbus
Zip: 42112
Country: United States

Status: Recruiting

Contact:
Last name: Mathew Cherian
Email: mathew.cherian@osumc.edu

Facility:
Name: Oklahoma University Health Sciences Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Contact:
Last name: Wajeeha Razaq

Phone: 405-271-4022
Email: wajeeha.usa@gmail.com

Facility:
Name: University of Pittsburgh Medical Center

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Status: Recruiting

Contact:
Last name: Adam Brufsky

Phone: (412) 641-4530
Email: brufskyam@upmc.edu

Facility:
Name: Lyndon B. Johnson Hospital

Address:
City: Houston
Zip: 77026
Country: United States

Status: Recruiting

Contact:
Last name: Senthil Damodaran
Email: SDamodaran@mdanderson.org

Facility:
Name: Baylor College of Medicine

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Ahmed Elkhanany
Email: Ahmed.Elkhanany@bcm.edu

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Senthil Damodaran
Email: SDamodaran@mdanderson.org

Facility:
Name: Harris Health System - Smith Clinic

Address:
City: Houston
Zip: 77054
Country: United States

Status: Recruiting

Contact:
Last name: Ahmed Elkhanany

Facility:
Name: University of Vermont Medical Center

Address:
City: Burlington
Zip: 05401
Country: United States

Status: Not yet recruiting

Contact:
Last name: Peter Kaufman
Email: Peter.Kaufman@uvmhealth.org

Facility:
Name: Blacktown Hospital

Address:
City: Blacktown
Country: Australia

Status: Recruiting

Contact:
Last name: Jennifer Man
Email: jennifer.man@health.nsw.gov.au

Facility:
Name: Concord Repatriation General Hospital

Address:
City: Concord
Country: Australia

Status: Not yet recruiting

Contact:
Last name: Belinda Kiely

Phone: +61 02 9767 6354
Email: belinda.kiely@health.nsw.gov.au

Facility:
Name: Mater Misericordiae Ltd, South Brisbane

Address:
City: South Brisbane
Country: Australia

Status: Not yet recruiting

Contact:
Last name: Kathryn Middleton

Phone: +61 07 31632531
Email: kathryn.middleton@mater.org.au

Facility:
Name: Cliniques Universitaires Saint-Luc

Address:
City: Brussels
Country: Belgium

Status: Not yet recruiting

Contact:
Last name: Francois Duhoux

Phone: +32 2 764 51 06
Email: francois.duhoux@saintluc.uclouvain.be

Facility:
Name: Antwerp University Hospital (UZA)

Address:
City: Edegem
Country: Belgium

Status: Not yet recruiting

Contact:
Last name: Sevilay Altintas

Phone: +32 3 821 49 73
Email: sevilay.altintas@uza.be

Facility:
Name: Universitaire Ziekenhuizen Leuven

Address:
City: Leuven
Country: Belgium

Status: Not yet recruiting

Contact:
Last name: Patrick Neven
Email: patrick.neven@uzleuven.be

Facility:
Name: Clinique CHC MontLégia

Address:
City: Liège
Country: Belgium

Status: Not yet recruiting

Contact:
Last name: Stephanie Marechal

Phone: +32 4 355 42 13
Email: stephanie.marechal@chc.be

Facility:
Name: CHU UCL Namur - Site De Sainte-Elisabeth

Address:
City: Namur
Country: Belgium

Status: Not yet recruiting

Contact:
Last name: Donatienne Taylor

Phone: 003281720524
Email: donatienne.taylor@chuuclnamur.uclouvain.be; donatienne.taylor@uclouvain.be

Facility:
Name: The Ottawa General Hospital

Address:
City: Ottawa
Country: Canada

Status: Recruiting

Contact:
Last name: Rakesh Goel

Phone: (613) 737-7700

Phone ext: 70171
Email: rgoel@ottawahospital.on.ca

Facility:
Name: Sunnybrook Health Sciences Centre -Bayview Campus

Address:
City: Toronto
Country: Canada

Status: Recruiting

Contact:
Last name: Ellen Warner

Phone: 416-480-4617
Email: ellen.warner@sunnybrook.ca

Facility:
Name: Hospital Maisonneuve-Rosemont

Address:
City: Montréal
Country: Canada

Status: Not yet recruiting

Contact:
Last name: Jonathan Noujaim
Email: jonathan.noujaim.ed@ssss.gouv.qc.ca

Facility:
Name: Lady Davis Institute for Medical Research Jewish General Hospital

Address:
City: Montréal
Country: Canada

Status: Not yet recruiting

Contact:
Last name: Parvaneh Fallah
Email: parvaneh.fallah@mail.mcgill.ca

Facility:
Name: Masarykuv onkologicky ustav

Address:
City: Brno
Country: Czechia

Status: Suspended

Facility:
Name: Fakultni nemocnice Hradec Kralove

Address:
City: Hradec Králové
Country: Czechia

Status: Suspended

Facility:
Name: Fakultni nemocnice Olomouc - Oncology clinic

Address:
City: Olomouc
Country: Czechia

Status: Suspended

Facility:
Name: Fakultní nemocnice v Motole

Address:
City: Praha 5
Country: Czechia

Status: Suspended

Facility:
Name: Service d'Oncologie Medicale - CHRU Besancon

Address:
City: Besançon
Country: France

Status: Not yet recruiting

Contact:
Last name: Laura Mansi

Facility:
Name: Institut Bergonie

Address:
City: Bordeaux
Country: France

Status: Not yet recruiting

Contact:
Last name: Marc Debled

Phone: +33 (0)5 56 33 04 77
Email: M.Debled@bordeaux.unicancer.fr

Facility:
Name: Centre Francois Baclesse

Address:
City: CAEN Cedex 05
Country: France

Status: Not yet recruiting

Contact:
Last name: George Emile
Email: g.emile@baclesse.unicancer.fr

Facility:
Name: Centre Oscar Lambret

Address:
City: Lille
Country: France

Status: Not yet recruiting

Contact:
Last name: Charlotte Bellier

Phone: +33 (0)3.20.29.59.59
Email: investigation@o-lambret.fr;c-bellier@o-lambret.fr

Facility:
Name: Centre Leon Berard

Address:
City: Lyon
Country: France

Status: Recruiting

Contact:
Last name: Thomas Bachelot

Phone: +33 4 78 78 26 54
Email: thomas.bachelot@lyon.unicancer.fr

Facility:
Name: Institut Paoli-Calmettes

Address:
City: Marseille
Country: France

Status: Recruiting

Contact:
Last name: Alexandre Tassin de Nonneville

Phone: +44491223789
Email: tassindenonnevillea@ipc.unicancer.fr

Facility:
Name: CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)

Address:
City: Poitiers
Country: France

Status: Not yet recruiting

Contact:
Last name: Nicolas Isambert
Email: nicolas.isambert@chu-poitiers.fr

Facility:
Name: Centre Henri Becquerel

Address:
City: Rouen
Country: France

Status: Not yet recruiting

Contact:
Last name: Marianne Leheurteur
Email: marianne.leheurteur@chb.unicancer.fr

Facility:
Name: Institut de cancerologie Strasbourg Europe (ICANS)

Address:
City: Strasbourg
Country: France

Status: Not yet recruiting

Contact:
Last name: Philippe Trensz

Phone: 0368767231
Email: p.trensz@icans.eu

Facility:
Name: Institut Claudius Regaud

Address:
City: Toulouse
Country: France

Status: Recruiting

Contact:
Last name: Florence Dalenc

Phone: (+33) 5 31 15 51 22
Email: dalenc.florence@iuct-oncopole.fr

Facility:
Name: Universitaetsklinikum Carl Gustav Carus Dresden

Address:
City: Dresden
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Pauline Wimberger

Phone: +49 (0)351 458-6728
Email: pauline.wimberger@uniklinikum.dresden.de

Facility:
Name: Universitaetsklinikum Ulm

Address:
City: Ulm
Country: Germany

Status: Not yet recruiting

Contact:
Last name: Brigitte Rack

Phone: +4973150058523
Email: brigitte.rack@uniklinik-ulm.de;studienzentrale.ufk@uniklinik-ulm.de

Facility:
Name: Rambam Health Care Campus

Address:
City: Haifa
Country: Israel

Status: Recruiting

Contact:
Last name: Ayelet Shai
Email: A_SHAI@rambam.health.gov.il

Facility:
Name: Hadassah Ein-Karem Medical Center

Address:
City: Jerusalem
Country: Israel

Status: Recruiting

Contact:
Last name: Ofra Maimon

Phone: +972505172570
Email: ofra406@hadassah.org.il

Facility:
Name: Shaare Zedek Medical Center

Address:
City: Jerusalem
Country: Israel

Status: Recruiting

Contact:
Last name: Hadar Goldvaser
Email: hadargo@szmc.org.il

Facility:
Name: Rabin MC

Address:
City: Petach Tikva
Country: Israel

Status: Recruiting

Contact:
Last name: Rinat Yerushalmi
Email: rinaty@clalit.org.il

Facility:
Name: Kaplan Medical Center

Address:
City: Reẖovot
Country: Israel

Status: Not yet recruiting

Contact:
Last name: Ella Evron
Email: allaev@clalit.org.il

Facility:
Name: Tel Aviv Sourasky Medical Center

Address:
City: Tel Aviv
Country: Israel

Status: Recruiting

Contact:
Last name: Amir Sonnenblick
Email: amirson@tlvmc.gov.il

Facility:
Name: Sheba Medical Center

Address:
City: Tel HaShomer
Country: Israel

Status: Recruiting

Contact:
Last name: Einav Nili Gal-Yam

Phone: +972-3-5302243
Email: Einav.NiliGal-Yam@sheba.health.gov.il

Facility:
Name: Centro Riferimento Oncologico - Aviano

Address:
City: Aviano
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Lorenzo Gerratana

Phone: (+39) 0434 659254
Email: lgerratana@gmail.com; lorenzo.gerratana@cro.it

Facility:
Name: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.

Address:
City: Meldola
Country: Italy

Status: Recruiting

Contact:
Last name: Michela Palleschi

Phone: +39 0543 739100
Email: michela.palleschi@irst.emr.it

Facility:
Name: Istituto Europeo di Oncologia

Address:
City: Milano
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Marco Angelo Colleoni

Phone: 02-57489.970
Email: marco.colleoni@ieo.it; emilia.montagna@ieo.it

Facility:
Name: Humanitas Istituto Clinico Catanese

Address:
City: Misterbianco
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Maria Vita Sanò

Phone: 09573390197
Email: maria.vita_sano@ccocatania.it

Facility:
Name: Azienda Ospedaliero-Universitaria di Modena

Address:
City: Modena
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Luca Moscetti

Phone: +390594223244
Email: moscetti.luca@aou.mo.it

Facility:
Name: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Address:
City: Napoli
Country: Italy

Status: Recruiting

Contact:
Last name: Michelino De Laurentiis

Phone: +3908117770442
Email: delauren@breastunit.org; m.delaurentiis@istitutotumori.na.it

Facility:
Name: Azienda Ospedaliero Universitaria di Parma

Address:
City: Parma
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Antonino Musolino

Phone: 00300521702660
Email: antonino.musolino@unipr.it

Facility:
Name: Fondazione IRCCS Policlinico San Matteo

Address:
City: Pavia
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Elisa Ferraris

Phone: 0382503689
Email: e.ferraris@smatteo.pv.it

Facility:
Name: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Address:
City: Roma
Country: Italy

Status: Recruiting

Contact:
Last name: Emilio Bria

Phone: +390630155202
Email: emiliobria@yahoo.it; emilio.bria@policlinicogemelli.it

Facility:
Name: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

Address:
City: Verona
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Elena Fiorio

Phone: 0458122769
Email: elena.fiorio@aovr.veneto.it; veronica.parolin@aovr.veneto.it;

Facility:
Name: National Cancer Center

Address:
City: Gyeonggi-do
Country: Korea, Republic of

Status: Not yet recruiting

Contact:
Last name: Keun Seok Lee
Email: kslee@ncc.re.kr

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Hwasun
Zip: 58128
Country: Korea, Republic of

Status: Not yet recruiting

Contact:
Last name: Hyun Jeong Shim

Phone: 82-61-379-7634
Email: hjnhj@jnu.ac.kr

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Status: Not yet recruiting

Contact:
Last name: Sung-Bae Kim

Phone: 82-2-3010-3217
Email: sbkim3@amc.seoul.kr

Facility:
Name: Korea University Anam Hospital

Address:
City: Seoul
Country: Korea, Republic of

Status: Not yet recruiting

Contact:
Last name: Kyong Hwa Park

Phone: 82-2-920-6841
Email: khpark@korea.ac.kr

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Country: Korea, Republic of

Status: Not yet recruiting

Contact:
Last name: Joo Hyuk Sohn

Phone: 82-2-2228-8135
Email: oncosohn@yuhs.ac

Facility:
Name: KO - MED Centra Kliniczne Sp. z o.o., Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

Address:
City: Biała Podlaska
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Maria Pawlowicz

Phone: +48 83 414 76 52
Email: maria.pawlowicz@szpitalbp.pl

Facility:
Name: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Address:
City: Gdańsk
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Jacek Jassem

Phone: 0048 58 349 2 270
Email: jjassem@gumed.edu.pl

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, I Klinika Radioterapii i Chemioterapii

Address:
City: Gliwice
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Michal Jarzab

Phone: 48 32 2788721
Email: michal.jarzab@io.gliwice.pl

Facility:
Name: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Onkologii Klinicznej

Address:
City: Kielce
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Pawel Sidel

Phone: +48 41 36 74 808
Email: Pawel.Sidel@onkol.kielce.pl

Facility:
Name: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Oddzial Onkologii Klinicznej z Pododdzialem Dziennym

Address:
City: Krakow
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Anna Kowalczyk-Tekiela

Phone: +48 502 315 790
Email: atekiela@interia.pl

Facility:
Name: SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej

Address:
City: Kraków
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Piotr Wysocki

Phone: 48 12 424-89-12
Email: piotr.wysocki@uj.edu.pl; klinikaonkologii@su.krakow.pl

Facility:
Name: NeuroMed

Address:
City: Lublin
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Tomasz Jankowski

Phone: +48602405127
Email: tjankowski.onkolog@wp.pl

Facility:
Name: Wielkopolskie Centrum Onkologii (WCO) / The Greater Poland Cancer Center

Address:
City: Poznań
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Pawel Rozanowski

Phone: +48 61 88 50 736
Email: pawel.rozanowski@euromail.pl

Facility:
Name: Mazowiecki Szpital Onkologiczny

Address:
City: Wieliszew
Country: Poland

Status: Not yet recruiting

Contact:
Last name: Sylwina Socha

Phone: +48 22 766 15 00

Phone ext: 134
Email: S.Socha@szpitalonkologiczny.pl

Facility:
Name: Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii

Address:
City: Łódź
Country: Poland

Status: Recruiting

Contact:
Last name: Ewa Kalinka

Phone: +48 42 271 11 07
Email: ewakalinka@wp.pl

Facility:
Name: Centrul Medical Focus

Address:
City: Bucharest
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Ingrid Iordan

Phone: 0721298677
Email: mireliordan@yahoo.com

Facility:
Name: Filantropia Clinical Hospital

Address:
City: Bucharest
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Dragos Median

Phone: +40 744 874350
Email: dragos.median@gmail.com

Facility:
Name: Radiotherapy Center Cluj

Address:
City: Cluj-Napoca
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Andrei Ungureanu

Phone: +40742206212
Email: andreiungureanu.oncolog@yahoo.com

Facility:
Name: Onco Clinic Consult SA

Address:
City: Craiova
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Patricia Visan

Phone: (+40) 724280084
Email: p.visan@oncoclinic.ro

Facility:
Name: Oncology Center Sfantul Nectarie

Address:
City: Craiova
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Michael Schenker

Phone: +40351401336
Email: mike_scheker@yahoo.com

Facility:
Name: Gral Medical SRL

Address:
City: Piteşti
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Adela-Luiza Chirila

Phone: +40766442720
Email: dr.adela_chirila@yahoo.com

Facility:
Name: OncoMed Oncology Center

Address:
City: Timişoara
Country: Romania

Status: Not yet recruiting

Contact:
Last name: Daniela Sirbu

Phone: +40 0744571617
Email: desirbu@yahoo.com

Facility:
Name: National Cancer Centre Singapore

Address:
City: Singapore
Zip: 168583
Country: Singapore

Status: Not yet recruiting

Contact:
Last name: Jing Yang Tira Tan

Phone: +6564368000
Email: tira.tan.j.y@singhealth.com.sq

Facility:
Name: Curie Oncology

Address:
City: Singapore
Zip: 329563
Country: Singapore

Status: Not yet recruiting

Contact:
Last name: Su-Mien Lynette Ngo

Phone: +6562595538
Email: lynettengo@curieoncology.com.sg

Facility:
Name: Hospital Clinic Barcelona

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: Tomas Pascual
Email: topascual@clinic.cat

Facility:
Name: Hospital Universitario Vall d'Hebron

Address:
City: Barcelona
Country: Spain

Status: Not yet recruiting

Contact:
Last name: Meritxell Bellet

Phone: +34932746000
Email: mbellet@vhio.net

Facility:
Name: Hospital Universitario Reina Sofia

Address:
City: Córdoba
Country: Spain

Status: Recruiting

Contact:
Last name: Juan de la Haba
Email: juahaba@gmail.com

Facility:
Name: Clinica Universidad de Navarra - Madrid

Address:
City: Madrid
Country: Spain

Status: Recruiting

Contact:
Last name: Jaime Espinos Jimenez
Email: jespinos@unav.es

Facility:
Name: Hospital General Universitario Gregorio Maranon

Address:
City: Madrid
Country: Spain

Status: Recruiting

Contact:
Last name: Sara Lopez- Tarruella Cobo
Email: slopeztarruella@gmail.com

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Country: Spain

Status: Recruiting

Contact:
Last name: Eva Ciruelos Gil

Phone: 0034913 90 80 00
Email: eva.ciruelos@gmail.com

Facility:
Name: Hospital Universitario de La Princesa

Address:
City: Madrid
Country: Spain

Status: Recruiting

Contact:
Last name: Ana Isabel Ballesteros

Phone: +34915202200
Email: oncologiamedica.princesa@outlook.com

Facility:
Name: Hospital Regional Universitario de Malaga

Address:
City: Málaga
Country: Spain

Status: Recruiting

Contact:
Last name: Ana Godoy Ortiz
Email: anagodort@gmail.com

Facility:
Name: Clinica Universidad de Navarra - Pamplona

Address:
City: Pamplona
Country: Spain

Status: Recruiting

Contact:
Last name: Jaime Espinos Jimenez
Email: jespinos@unav.es

Facility:
Name: Instituto Valenciano de Oncologia

Address:
City: Valencia
Country: Spain

Status: Recruiting

Contact:
Last name: Angel Guerrero Zotano

Phone: +34 96 111 4051
Email: aguerrero@fivo.org

Facility:
Name: Changhua Christian Hospital (CCH)

Address:
City: Changhua
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Shou-Tung Chen
Email: 1886@cch.org.tw

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Address:
City: Kaohsiung
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Ming-Feng Hou
Email: mifeho@kmu.edu.tw

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Wei-Pang Chung

Phone: +886975014242
Email: edgarbun@gmail.com

Facility:
Name: Tri-Service General Hospital

Address:
City: Taipei City
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Ming-Shen Dai

Phone: +886-2-87927208
Email: dms1201@gmail.com

Facility:
Name: Koo Foundation Sun Yat-Sen Cancer Center

Address:
City: Taipei
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Chi-Feng Chung
Email: cheh@kfsyscc.org

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Chiun-Sheng Huang
Email: huangcs@ntu.edu.tw

Facility:
Name: Linkou Chang Gung Memorial Hospital (CGMHLK)

Address:
City: Taoyuan City
Country: Taiwan

Status: Not yet recruiting

Contact:
Last name: Shin-Cheh Chen
Email: chensc@cgmh.org.tw

Facility:
Name: Trakya University Medical Faculty

Address:
City: Merkez
Country: Turkey

Status: Suspended

Facility:
Name: Kocaeli University Faculty of Medicine

Address:
City: İzmit
Country: Turkey

Status: Suspended

Facility:
Name: Ankara University Medical Faculty Medical Oncology Department

Address:
City: Ankara
Country: Turkey

Status: Suspended

Facility:
Name: Uludag University Medical Faculty

Address:
City: Bursa
Country: Turkey

Status: Suspended

Facility:
Name: Liv Hospital Ankara

Address:
City: Cankaya
Country: Turkey

Status: Suspended

Facility:
Name: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Address:
City: Istanbul
Country: Turkey

Status: Suspended

Facility:
Name: Medical Point Izmir Hospital

Address:
City: İzmir
Country: Turkey

Status: Suspended

Facility:
Name: Suat Seren Training and Research Hospital

Address:
City: İzmir
Country: Turkey

Status: Suspended

Facility:
Name: West Middlesex University Hospital

Address:
City: Isleworth
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Pippa Riddle

Phone: 02083216781
Email: pippa.riddle@nhs.net

Facility:
Name: Leeds Teaching Hospitals NHS Trust

Address:
City: Leeds
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Chris Twelves
Email: C.J.Twelves@leeds.ac.uk

Facility:
Name: The Christie NHS Foundation Trust

Address:
City: Manchester
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Anne Armstrong

Facility:
Name: Nottingham City Hospital

Address:
City: Nottingham
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Sarah Khan

Facility:
Name: Lancashire Teaching Hospitals

Address:
City: Preston
Country: United Kingdom

Status: Not yet recruiting

Contact:
Last name: Martin Hogg
Email: martin.hogg@lthtr.nhs.uk

Start date: October 31, 2023

Completion date: June 2026

Lead sponsor:
Agency: Sermonix Pharmaceuticals Inc.
Agency class: Industry

Source: Sermonix Pharmaceuticals Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05696626

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