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
