Clinical trial • Phase III • Oncology

sacituzumab govitecan for Triple negative breast cancer

Phase III trial of sacituzumab govitecan for Triple negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple negative breast cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
28-06-2024
First CTIS Authorization Date
22-10-2024

Trial design

Randomised, open-label, treatment of physician's choice (tpc) which may include: xeloda (capecitabine) 500 mg film-coated tablets, oral (dose units reported mg/m2; product data lists max daily dose 1000 mg/m2 and max total dose amount 28000 mg/m2); keytruda (pembrolizumab) 25 mg/ml concentrate for solution for infusion (pembrolizumab 200 mg iv dosing is referenced in study text, e.g., adjuvant pembrolizumab 200 mg q3w allowed prior to study entry).-controlled Phase III trial in Germany, Ireland, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician's Choice (TPC) which may include: Xeloda (capecitabine) 500 mg film-coated tablets, oral (dose units reported mg/m2; product data lists max daily dose 1000 mg/m2 and max total dose amount 28000 mg/m2); KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion (pembrolizumab 200 mg IV dosing is referenced in study text, e.g., adjuvant pembrolizumab 200 mg Q3W allowed prior to study entry).
Target Sample Size
756

Eligibility

Recruits 756 Vulnerable population flag is selected (isVulnerablePopulationSelected: true). Participants must be 18 years or older (or minimum age per country-specific requirements) and be able to understand and give written informed consent. Consent is obtained directly from the participant (written ICF). Partner/pregnancy follow-up ICFs and additional partner/pregnancy information documents are provided (partner/pregnancy follow-up ICF documents are listed in the trial documents). No assent procedures for minors are described (minors are excluded)..

Vulnerable Population
Vulnerable population flag is selected (isVulnerablePopulationSelected: true). Participants must be 18 years or older (or minimum age per country-specific requirements) and be able to understand and give written informed consent. Consent is obtained directly from the participant (written ICF). Partner/pregnancy follow-up ICFs and additional partner/pregnancy information documents are provided (partner/pregnancy follow-up ICF documents are listed in the trial documents). No assent procedures for minors are described (minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Assigned male or female at birth 18 years of age or older (or minimum age according to country-specific requirements), able to understand and give written informed consent"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1"}
  • {"criterion_text":"- Patients must have a history of clinical stage T1, N1-2 or T2-4, N0-2 and histologically confirmed TNBC as determined by the investigator with residual invasive disease in the breast or lymph node(s) after completion of neoadjuvant therapy and surgery. Additionally, the presence of distant metastatic disease must be ruled out. TNBC criteria for the study is defined as ER and PgR ≤10%, HER2-negative per ASCO/CAP guidelines (IHC and/or ISH) TNBC confirmation from posttreatment surgical tissue is preferred if possible . In the case of discordant expression results, eligibility must be discussed and determined on a case-by-case basis with the sponsor medical monitor. Staging should be done according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer, eighth edition. In the case of known local progression during neoadjuvant therapy, distant metastases must be excluded by adequate imaging (computed tomography [CT]/magnetic resonance imaging [MRI] recommended) prior to study entry."}
  • {"criterion_text":"- Patients must have received neoadjuvant chemotherapy (taxane and/or anthracycline-based regimen) with or without an aPD-(L)1 or platinum agent for a minimum of 6 cycles or 18 weeks prior to surgery. Note: For patients who have received pembrolizumab in the neoadjuvant setting, up to 3 cycles of adjuvant pembrolizumab 200 mg Q3W administered with or without radiotherapy is allowed prior to study entry. Note: Enrollment of patients who have not received prior neoadjuvant aPD-(L)1 therapy will be capped at approximately 10%."}
  • {"criterion_text":"- Adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes as follows: Breast surgery: breast-conserving surgery with histologically negative margins of excision or total mastectomy with no gross residual disease at the margin of resection, and ideally, should be histologically negative as well. For patients who underwent breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection. If invasive disease is present in both breasts, participation in the study is permitted as long as the other eligibility criteria are met. Lymph node surgery: In case of positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy, additional surgical evaluation of the axilla following preoperative therapy should have been performed (eg, sentinel node evaluation, targeted axillary dissection, and or axillary lymph node dissection [ALND]). If sentinel node biopsy performed before preoperative therapy was negative, no additional surgery evaluation of the axilla is required after preoperative therapy. If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is recommended. If sentinel node biopsy performed after preoperative therapy is positive with macrometastases, ALND is required. In the presence of micrometastases, ALND is recommended unless not clinically feasible or not aligned with local/institutional practice. If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required. Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy. The presence of micrometastases in lymph nodes after preoperative therapy counts as residual invasive disease, whereas the presence of isolated tumor cells (ITCs) does not. If patients have ITCs in the setting of residual breast disease, nodal irradiation is recommended."}
  • {"criterion_text":"- Patients must have received appropriate radiotherapy and have recovered prior to starting study treatment. At a minimum radiotherapy is required for the following: Breast-conserving surgery: whole breast radiation is required. Regional node radiation is required if the patient presented with cT3-4 or cN2 disease at initial diagnosis. Total mastectomy: chest wall and regional node radiation is required if the patient presented with cT3-4 or cN2 disease at initial diagnosis."}
  • {"criterion_text":"- Adequate Hepatic function."}

Exclusion criteria

  • {"criterion_text":"- Stage IV (metastatic) breast cancer"}
  • {"criterion_text":"- Inadequate cardiac function postoperatively, ie, screening LVEF < 50% on ECHO or MUGA"}
  • {"criterion_text":"- Have previously received topoisomerase 1 inhibitors or ADCs containing a topoisomerase inhibitor"}
  • {"criterion_text":"- Have received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)."}
  • {"criterion_text":"- Met any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation c) New York Heart Association (NYHA) Class III or greater congestive heart failure"}
  • {"criterion_text":"- Prior neoadjuvant HER2-directed therapy; prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment. ■ Endocrine therapy for fertility preservation is an exception to this criterion. Note: For patients with hormone receptor low expression (ER or PgR ≥ 1% and ≤ 10%), endrocrine therapy is permitted per investigator’s discretion after completion of on-study treatment."}
  • {"criterion_text":"- Concurrent serious uncontrolled infections requiring treatment"}
  • {"criterion_text":"- History of any prior (ipsi- or contralateral) invasive breast cancer. Note: Prior DCIS is allowed."}
  • {"criterion_text":"- Patients with germline BRCA mutations"}
  • {"criterion_text":"- Evidence of recurrent disease (locoregional and/or distant relapse) following preoperative therapy and surgery"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, or invasive contralateral breast cancer.","definition_or_measurement_approach":"iDFS measured as time from randomization to death from any cause or first occurrence of invasive local, regional, or distant recurrence, or invasive contralateral breast cancer."}

Secondary endpoints

  • {"endpoint_text":"- OS is defined as the time from the date of randomization until death due to any cause.","definition_or_measurement_approach":"Overall survival measured as time from randomization until death from any cause."}
  • {"endpoint_text":"- dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.","definition_or_measurement_approach":"Distant disease-free survival measured as time from randomization to death or distant recurrence or second primary invasive cancer."}
  • {"endpoint_text":"- RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence","definition_or_measurement_approach":"Recurrence-free survival measured as time from randomization to death or invasive local, regional, or distant recurrence."}
  • {"endpoint_text":"- Incidence of TEAEs and clinical laboratory abnormalities","definition_or_measurement_approach":"Safety assessed by incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities per standard AE reporting and laboratory criteria."}
  • {"endpoint_text":"- TTW of QoL based on FACT-B Trial Outcome Index (TOI) score","definition_or_measurement_approach":"Time to worsening (TTW) of quality of life measured by FACT-B Trial Outcome Index (TOI) score changes over time."}

Recruitment

Planned Sample Size
756
Recruitment Window Months
103
Consent Approach
Written informed consent is required from each participant (participants must be able to understand and give written informed consent). ICFs and participant-facing materials are provided in country/language-specific versions (documents listed for Germany, Ireland, Spain, France, Belgium, Italy in respective languages such as German, English, Spanish, French, Italian, Dutch). Partner/pregnancy follow-up ICFs and optional genomic/future research ICFs are available as separate documents.

Geography

Total Number Of Sites
137
Total Number Of Participants
758

Germany

Earliest CTIS Part Ii Submission Date
20-07-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
566
Number Of Sites
52
Number Of Participants
316

Sites

Site Name
Haematologie-Onkologie im Zentrum MVZ GmbH
Department Name
Hämatologie-Onkologie
Principal Investigator Name
Bernhard Heinrich
Principal Investigator Email
bernhard.heinrich@hop-augsburg.de
Contact Person Name
Bernhard Heinrich
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Marion Tina van Mackelenbergh
Principal Investigator Email
mariontina.vanmackelenbergh@uksh.de
Contact Person Name
Marion Tina van Mackelenbergh
Site Name
Evangelische Kliniken Gelsenkirchen GmbH
Department Name
Brustzentrum
Principal Investigator Name
Hans Holger Fischer
Principal Investigator Email
fischer@evk-ge.de
Contact Person Name
Hans Holger Fischer
Contact Person Email
fischer@evk-ge.de
Site Name
Marien Hospital Witten
Department Name
Gynäkologie u. Geburtshilfe
Principal Investigator Name
Monika Graeser
Principal Investigator Email
monika.graeser@elisabethgruppe.de
Contact Person Name
Monika Graeser
Site Name
Sana Klinikum Offenbach GmbH
Department Name
Ambulantes Onkologisches Zentrum
Principal Investigator Name
Sabine Seiler
Principal Investigator Email
sabine.seiler@sana.de
Contact Person Name
Sabine Seiler
Contact Person Email
sabine.seiler@sana.de
Site Name
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
Department Name
Frauenklinik
Principal Investigator Name
Oliver Tomé
Principal Investigator Email
oliver.tome@vincentius-ka.de
Contact Person Name
Oliver Tomé
Contact Person Email
oliver.tome@vincentius-ka.de
Site Name
Universitat Heidelberg
Department Name
Frauenklinik
Principal Investigator Name
Frederik Marmé
Principal Investigator Email
frederik.marme@umm.de
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
Studien GbR Braunschweig
Department Name
Onkologie
Principal Investigator Name
Janine Kreiss-Sender
Principal Investigator Email
kreiss-sender@frauenaerzte-casparistr.de
Contact Person Name
Janine Kreiss-Sender
Site Name
Dr. Busch MVZ GmbH
Principal Investigator Name
Steffi Busch
Principal Investigator Email
s.busch@mvz-busch.de
Contact Person Name
Steffi Busch
Contact Person Email
s.busch@mvz-busch.de
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
Gynäkologie und Geburtshilfe
Principal Investigator Name
Michael Patrick Lux
Principal Investigator Email
m.lux@vincenz.de
Contact Person Name
Michael Patrick Lux
Contact Person Email
m.lux@vincenz.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Frauenheilkunde
Principal Investigator Name
Bahriye Aktas
Principal Investigator Email
bahriye.aktas@medizin.uni-leipzig.de
Contact Person Name
Bahriye Aktas
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Oncologie
Principal Investigator Name
Elise DELUCHE
Principal Investigator Email
elise.deluche@chu-limoges.fr
Contact Person Name
Elise DELUCHE
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Angelina Fink
Principal Investigator Email
studienzentrale.ufk@uniklinik-ulm.de
Contact Person Name
Angelina Fink
Site Name
Praxisklinik Krebsheilkunde Fuer Frauen
Department Name
Onkologie
Principal Investigator Name
Gülten Oskay-Özcelik
Principal Investigator Email
studienoskay@medionko.de
Contact Person Name
Gülten Oskay-Özcelik
Contact Person Email
studienoskay@medionko.de
Site Name
Klinikum Esslingen GmbH
Department Name
Gynäkologisches Krebszentrum
Principal Investigator Name
Alexander Hein
Principal Investigator Email
a.hein.cto@klinikum-esslingen.de
Contact Person Name
Alexander Hein
Site Name
MVZ fuer Haematologie und Onkologie Ravensburg GmbH
Department Name
Onkologie Hämatologie
Principal Investigator Name
Thomas Decker
Principal Investigator Email
thomas.decker@onkonet.eu
Contact Person Name
Thomas Decker
Contact Person Email
thomas.decker@onkonet.eu
Site Name
Onkologische Schwerpunktpraxis Bielefeld
Department Name
Onkologie
Principal Investigator Name
Siemke Steinke
Principal Investigator Email
Siemke.Steinke@onkologie-bielefeld.de
Contact Person Name
Siemke Steinke
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Senology und gynäkologische systematische Therapie
Principal Investigator Name
Mustafa Aydogdu
Principal Investigator Email
mustafa.aydogdu@klinikum-bremen-mitte.de
Contact Person Name
Mustafa Aydogdu
Site Name
Luisenkrankenhaus GmbH & Co. KG
Department Name
MVZ Luisenkrankenhaus
Principal Investigator Name
Athina Kostara
Principal Investigator Email
athina.kostara@gynonco.de
Contact Person Name
Athina Kostara
Contact Person Email
athina.kostara@gynonco.de
Site Name
Rotkreuzklinikum Muenchen gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Claus Hanusch
Principal Investigator Email
claus.hanusch@swmbrk.de
Contact Person Name
Claus Hanusch
Contact Person Email
claus.hanusch@swmbrk.de
Site Name
Knappschaft Kliniken Bottrop GmbH
Department Name
Klinik für Gynäkologie u. Geburtshilfe
Principal Investigator Name
Hans Christian Kolberg
Principal Investigator Email
hans-christian.kolberg@mhb-bottrop.de
Contact Person Name
Hans Christian Kolberg
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Brustzentrum
Principal Investigator Name
Jennifer Spönlein
Principal Investigator Email
j.spoenlein@kem-med.com
Contact Person Name
Jennifer Spönlein
Contact Person Email
j.spoenlein@kem-med.com
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Department of Obstetricts and Gynecology
Principal Investigator Name
Peter Fasching
Principal Investigator Email
fk-management-cru@uk-erlangen.de
Contact Person Name
Peter Fasching
Site Name
Medical Center - University Of Freiburg
Department Name
Gynäkologie
Principal Investigator Name
Beate Rautenberg
Principal Investigator Email
beate.rautenberg@uniklinik-freiburg.de
Contact Person Name
Beate Rautenberg
Site Name
Vinzenz Von Paul Kliniken gGmbH
Department Name
Onkologie
Principal Investigator Name
Manfred Hofmann
Principal Investigator Email
manfred.hofmann@vinzenz.de
Contact Person Name
Manfred Hofmann
Contact Person Email
manfred.hofmann@vinzenz.de
Site Name
ÜBAG Dres. Wierecky & Brandl
Department Name
Haematology and Oncology
Principal Investigator Name
Elke Hennes
Principal Investigator Email
hennes@onkologie-hamburg.de
Contact Person Name
Elke Hennes
Contact Person Email
hennes@onkologie-hamburg.de
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Onkologie
Principal Investigator Name
Vesna Bjelic-Radisic
Principal Investigator Email
vesna.bjelic-radisic@helios-gesundheit.de
Contact Person Name
Vesna Bjelic-Radisic
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Principal Investigator Name
Dirk Bauerschlag
Principal Investigator Email
dirk.bauerschlag@med.uni.jena.de
Contact Person Name
Dirk Bauerschlag
Site Name
Klinikum Oldenburg AöR
Department Name
Onkologie und Haematologie
Principal Investigator Name
Andrea Renzelmann
Principal Investigator Email
renzelmann.andrea@klinikum-oldenburg.de
Contact Person Name
Andrea Renzelmann
Site Name
Klinikum Worms gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Eva Werner
Principal Investigator Email
eva.werner@klinikum-worms.de
Contact Person Name
Eva Werner
Contact Person Email
eva.werner@klinikum-worms.de
Site Name
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH
Department Name
Senologie/Brustzentrum
Principal Investigator Name
Dagmar Langanke
Principal Investigator Email
senologie@ek-leipzig.de
Contact Person Name
Dagmar Langanke
Contact Person Email
senologie@ek-leipzig.de
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Onkologie
Principal Investigator Name
Joachim Rom
Principal Investigator Email
Joachim.rom@varisano.de
Contact Person Name
Joachim Rom
Contact Person Email
Joachim.rom@varisano.de
Site Name
MVZ GynKrefeld GmbH
Department Name
Onco-Gynaecology
Principal Investigator Name
Marina Wirtz
Principal Investigator Email
marina.wirtz@zago-krefeld.de
Contact Person Name
Marina Wirtz
Contact Person Email
marina.wirtz@zago-krefeld.de
Site Name
St. Josefs-Hospital Wiesbaden GmbH
Department Name
Gynäkologie und Geburtshilfe
Principal Investigator Name
Antje Lehnert
Principal Investigator Email
alehnert@joho.de
Contact Person Name
Antje Lehnert
Contact Person Email
alehnert@joho.de
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Onkologie
Principal Investigator Name
Christian Schem
Principal Investigator Email
studien@mammazentrum.eu
Contact Person Name
Christian Schem
Contact Person Email
studien@mammazentrum.eu
Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Frauenklinik
Principal Investigator Name
Nicole Stahl
Principal Investigator Email
nicole.stahl2@helios-gesundheit.de
Contact Person Name
Nicole Stahl
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Theresa Link
Principal Investigator Email
Theresa.Link@uniklinikum-dresden.de
Contact Person Name
Theresa Link
Site Name
Franziskus Hospital Harderberg
Department Name
Medizinisches Versorgungszentrum II der Niels Stensen Kliniken
Principal Investigator Name
Kerstin Lüdtke-Heckenkamp
Contact Person Name
Kerstin Lüdtke-Heckenkamp
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Frauengesundheit
Principal Investigator Name
Andreas Hartkopf
Principal Investigator Email
andreas.hartkopf@med.uni-tuebingen.de
Contact Person Name
Andreas Hartkopf
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Department Name
Onkologie
Principal Investigator Name
Rudolf Weide
Principal Investigator Email
weide@invo-koblenz.de
Contact Person Name
Rudolf Weide
Contact Person Email
weide@invo-koblenz.de
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Gynäkologie und Geburtshilfe
Principal Investigator Name
Dorothea Fischer
Principal Investigator Email
dorothea.fischer@klinikumevb.de
Contact Person Name
Dorothea Fischer
Site Name
Gemeinschaftspraxis Dr. Kronawitter/Dr. Jung
Principal Investigator Name
Christoph Jung
Principal Investigator Email
onkologie-traunstein@t-online.de
Contact Person Name
Christoph Jung
Site Name
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Principal Investigator Name
Roswitha Fuchs
Principal Investigator Email
info@onkologie-langen.de
Contact Person Name
Roswitha Fuchs
Contact Person Email
info@onkologie-langen.de
Site Name
Kath. St. Paulus GmbH
Department Name
Onkologie
Principal Investigator Name
Georg Kunz
Principal Investigator Email
georg.kunz@joho-dortmund.de
Contact Person Name
Georg Kunz
Contact Person Email
georg.kunz@joho-dortmund.de
Site Name
Hämato-Onkologische Praxis im Medicum
Department Name
Onkologie
Principal Investigator Name
Carsten Schreiber
Principal Investigator Email
carstenschreiber@home-bremen.com
Contact Person Name
Carsten Schreiber
Site Name
St. Elisabeth Krankenhaus GmbH
Department Name
Gynäkologie und Gynäkologische Onkologie
Principal Investigator Name
Julian Puppe
Principal Investigator Email
julian.puppe@hohenlind.de
Contact Person Name
Julian Puppe
Contact Person Email
julian.puppe@hohenlind.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Gynäkologie und Gynäkologische Onkologie
Principal Investigator Name
Marc Thill
Principal Investigator Email
marc.thill@agaplesion.de
Contact Person Name
Marc Thill
Contact Person Email
marc.thill@agaplesion.de
Site Name
Klinikum Suedstadt Rostock
Department Name
Universitätsfrauen- und Poliklini
Principal Investigator Name
Toralf Reimer
Principal Investigator Email
toralf.reimer@kliniksued-rostock.de
Contact Person Name
Toralf Reimer
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Onkologie
Principal Investigator Name
Michael Untch
Principal Investigator Email
michael.untch@helios-gesundheit.de
Contact Person Name
Michael Untch
Site Name
Klinik Dr. Hancken GmbH
Department Name
Onkologie/Hämotologie
Principal Investigator Name
Wiebke Timm
Principal Investigator Email
wiebke.timm@hancken.de
Contact Person Name
Wiebke Timm
Contact Person Email
wiebke.timm@hancken.de
Site Name
Elisabeth Krankenhaus GmbH
Department Name
Brustzentrum
Principal Investigator Name
Sabine Schmatloch
Principal Investigator Email
sschmatloch@ekh-ks.de
Contact Person Name
Sabine Schmatloch
Contact Person Email
sschmatloch@ekh-ks.de
Site Name
Universitaet Muenster
Department Name
Sektion Senologie
Principal Investigator Name
Joke Tio
Principal Investigator Email
joke.tio@ukmuenster.de
Contact Person Name
Joke Tio
Contact Person Email
joke.tio@ukmuenster.de

Ireland

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
438
Number Of Sites
5
Number Of Participants
32

Sites

Site Name
University Hospital Limerick
Department Name
Oncology
Principal Investigator Name
Grzegorz Korpanty
Principal Investigator Email
Greg.Korpanty2@hse.ie
Contact Person Name
Grzegorz Korpanty
Contact Person Email
Greg.Korpanty2@hse.ie
Site Name
St James's Hospital
Department Name
Oncology
Principal Investigator Name
Niamh Coleman
Principal Investigator Email
NiaColeman@stjames.ie
Contact Person Name
Niamh Coleman
Contact Person Email
NiaColeman@stjames.ie
Site Name
Beaumont Hospital
Department Name
Oncology
Principal Investigator Name
Patrick Morris
Principal Investigator Email
patrickmorris@beaumont.ie
Contact Person Name
Patrick Morris
Contact Person Email
patrickmorris@beaumont.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Oncology
Principal Investigator Name
Shahid Iqbal
Principal Investigator Email
shahidiqbal@mater.ie
Contact Person Name
Shahid Iqbal
Contact Person Email
shahidiqbal@mater.ie
Site Name
Cork University Hospital
Department Name
Oncology
Principal Investigator Name
Seamus O'Reilly
Principal Investigator Email
Seamus.OReilly@hse.ie
Contact Person Name
Seamus O'Reilly
Contact Person Email
Seamus.OReilly@hse.ie

Spain

Earliest CTIS Part Ii Submission Date
16-07-2024
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
645
Number Of Sites
36
Number Of Participants
214

Sites

Site Name
Hospital San Pedro De Alcantara
Department Name
Oncology
Principal Investigator Name
Santiago Gonzalez Santiago
Principal Investigator Email
ucancer.hspa@salud-juntaex.es
Contact Person Name
Santiago Gonzalez Santiago
Contact Person Email
ucancer.hspa@salud-juntaex.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Principal Investigator Name
Cristina Arqueros Nuñez
Principal Investigator Email
carqueros@santpau.cat
Contact Person Name
Cristina Arqueros Nuñez
Contact Person Email
carqueros@santpau.cat
Site Name
Hospital Universitario De Jaen
Department Name
Oncology
Principal Investigator Name
Alicia Cano Jiménez
Principal Investigator Email
alicia.cano.sspa@juntadeandalucia.es
Contact Person Name
Alicia Cano Jiménez
Site Name
Hospital Universitario De Canarias
Department Name
Oncology
Principal Investigator Name
Josefina Cruz jurado
Principal Investigator Email
jcruzjurado@gmail.com
Contact Person Name
Josefina Cruz jurado
Contact Person Email
jcruzjurado@gmail.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Oncology
Principal Investigator Name
Serafín Moreales Murillo
Principal Investigator Email
serafinmorales01@gmail.com
Contact Person Name
Serafín Moreales Murillo
Contact Person Email
serafinmorales01@gmail.com
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Oncology
Principal Investigator Name
Alicia De Luna Aguilar
Principal Investigator Email
alicia.delunaguilar@gmail.com
Contact Person Name
Alicia De Luna Aguilar
Contact Person Email
alicia.delunaguilar@gmail.com
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Oncology
Principal Investigator Name
María Valero Arbizu
Principal Investigator Email
info@oncoavanze.es
Contact Person Name
María Valero Arbizu
Contact Person Email
info@oncoavanze.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Mireia Margelí Vila
Principal Investigator Email
mmargeli@iconcologia.net
Contact Person Name
Mireia Margelí Vila
Contact Person Email
mmargeli@iconcologia.net
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Oncology
Principal Investigator Name
Ricardo Sánchez-Escribano Morcuende
Principal Investigator Email
rsancheze@saludcastillayleon.es
Contact Person Name
Ricardo Sánchez-Escribano Morcuende
Site Name
Hospital De Galdakao Usansolo
Department Name
Oncology
Principal Investigator Name
Josefa Ferreiro Quintana
Principal Investigator Email
josefa.ferreiroquintana@osakidetza.eus
Contact Person Name
Josefa Ferreiro Quintana
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Principal Investigator Name
Isabel Manuela Álvarez López
Principal Investigator Email
isabelmanuela.alvarezlopez@osakidetza.eus
Contact Person Name
Isabel Manuela Álvarez López
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Bárbara Adamo
Principal Investigator Email
Adamo@clinic.cat
Contact Person Name
Bárbara Adamo
Contact Person Email
Adamo@clinic.cat
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Principal Investigator Name
Verónica Conde Herrero
Principal Investigator Email
veronica.conde.sspa@juntadeandalucia.es
Contact Person Name
Verónica Conde Herrero
Site Name
Consorcio Hospitalario Provincial De Castellon
Department Name
Oncology
Principal Investigator Name
María Fonfría Esparcia
Principal Investigator Email
maria.fonfria@hospitalprovincial.es
Contact Person Name
María Fonfría Esparcia
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Principal Investigator Name
Marta Santisteban Eslava
Principal Investigator Email
msantisteb@unav.es
Contact Person Name
Marta Santisteban Eslava
Contact Person Email
msantisteb@unav.es
Site Name
Hospital Universitario De Toledo
Department Name
Oncology
Principal Investigator Name
Ana María García Tapiador
Principal Investigator Email
latapiador@hotmail.com
Contact Person Name
Ana María García Tapiador
Contact Person Email
latapiador@hotmail.com
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Oncology
Principal Investigator Name
Clara Martínez Vila
Principal Investigator Email
cmartinezv@althaia.cat
Contact Person Name
Clara Martínez Vila
Contact Person Email
cmartinezv@althaia.cat
Site Name
Hospital General Universitario De Elche
Department Name
Oncology
Principal Investigator Name
Álvaro Rodríguez Lescure
Principal Investigator Email
oncologia_elx@gva.cs
Contact Person Name
Álvaro Rodríguez Lescure
Contact Person Email
oncologia_elx@gva.cs
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology
Principal Investigator Name
Antonio Antón Torres
Principal Investigator Email
aantont@gmail.com
Contact Person Name
Antonio Antón Torres
Contact Person Email
aantont@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Begoña Jiménez Rodíguez
Principal Investigator Email
bego.jimenez@ibima.eu
Contact Person Name
Begoña Jiménez Rodíguez
Contact Person Email
bego.jimenez@ibima.eu
Site Name
Hospital General Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Vega Iranzo González Cruz
Principal Investigator Email
iranzo_veg@gva.es
Contact Person Name
Vega Iranzo González Cruz
Contact Person Email
iranzo_veg@gva.es
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Oncology
Principal Investigator Name
María Isabel Blancas López-Barajas
Principal Investigator Email
misabel.blancas.sspa@juntadeandalucia.es
Contact Person Name
María Isabel Blancas López-Barajas
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
Francisco Javier Pascual López
Principal Investigator Email
javier.pascual@ibima.eu
Contact Person Name
Francisco Javier Pascual López
Contact Person Email
javier.pascual@ibima.eu
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Principal Investigator Name
Luis De la Cruz Merino
Principal Investigator Email
oncomacarena@gmail.com
Contact Person Name
Luis De la Cruz Merino
Contact Person Email
oncomacarena@gmail.com
Site Name
Salut Sant Joan De Reus
Department Name
Oncology
Principal Investigator Name
Kepa Amilano Párraga
Principal Investigator Email
oncologia@salutsantjoan.cat
Contact Person Name
Kepa Amilano Párraga
Contact Person Email
oncologia@salutsantjoan.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
Carmen Hinojo González
Principal Investigator Email
carmen.hinojo@scsalud.es
Contact Person Name
Carmen Hinojo González
Contact Person Email
carmen.hinojo@scsalud.es
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Oncology
Principal Investigator Name
Juan Antonio Guerra Martínez
Principal Investigator Email
juanantonio.guerra@salud.madrid.org
Contact Person Name
Juan Antonio Guerra Martínez
Site Name
Hospital Universitario De Cruces
Department Name
Oncology
Principal Investigator Name
María Itziar Rubio Etxebarri
Principal Investigator Email
mariaiciar.rubioechevarria@osakidetza.eus
Contact Person Name
María Itziar Rubio Etxebarri
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Juan Rafaél De La Haba Rodríguez
Principal Investigator Email
jrhaba@uco.es
Contact Person Name
Juan Rafaél De La Haba Rodríguez
Contact Person Email
jrhaba@uco.es
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Principal Investigator Name
Javier Cortés Castán
Principal Investigator Email
Javier.cortes@maj3.health
Contact Person Name
Javier Cortés Castán
Contact Person Email
Javier.cortes@maj3.health
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Sara López-Tarruella Cobo
Principal Investigator Email
sara.lopeztarruella@salud.madrid.org
Contact Person Name
Sara López-Tarruella Cobo
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Begoña Bermejo de las Heras
Principal Investigator Email
begobermejo@gmail.com
Contact Person Name
Begoña Bermejo de las Heras
Contact Person Email
begobermejo@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Elsa Dalmau Portulas
Principal Investigator Email
edalmau@tauli.cat
Contact Person Name
Elsa Dalmau Portulas
Contact Person Email
edalmau@tauli.cat
Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
María Martínez García
Principal Investigator Email
MariaMartinezGarcia@parcdesalutmar.cat
Contact Person Name
María Martínez García
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
Silvia Antolín Novoa
Principal Investigator Email
ensayos.clinicos.onco.asacec@sergas.es
Contact Person Name
Silvia Antolín Novoa
Site Name
Hospital Universitario De Leon
Department Name
Oncology
Principal Investigator Name
Ana López González
Principal Investigator Email
alopezgo@saludcastillayleon.es
Contact Person Name
Ana López González
Contact Person Email
alopezgo@saludcastillayleon.es

France

Earliest CTIS Part Ii Submission Date
08-01-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
429
Number Of Sites
18
Number Of Participants
70

Sites

Site Name
Groupe Hospitalier Saint Vincent
Department Name
Oncologie
Principal Investigator Name
Youssef TAZI
Principal Investigator Email
ytazi@solcrr.org
Contact Person Name
Youssef TAZI
Contact Person Email
ytazi@solcrr.org
Site Name
Institut Gustave Roussy
Department Name
Oncologie
Principal Investigator Name
Alessandra VIANSONE
Principal Investigator Email
alessandro.viansone@gustaveroussy.fr
Contact Person Name
Alessandra VIANSONE
Site Name
Institut De Cancerologie De Bourgogne
Department Name
Oncologie
Principal Investigator Name
Veronique LORGIS
Principal Investigator Email
vlorgis@chb-cancer.fr
Contact Person Name
Veronique LORGIS
Contact Person Email
vlorgis@chb-cancer.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie
Principal Investigator Name
Elise DELUCHE
Principal Investigator Email
elise.deluche@chu-limoges.fr
Contact Person Name
Elise DELUCHE
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
Medipole De Nancy
Department Name
Oncologie
Principal Investigator Name
Raafet AFFI
Principal Investigator Email
r.affi@ilcgroupe.fr
Contact Person Name
Raafet AFFI
Contact Person Email
r.affi@ilcgroupe.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie
Principal Investigator Name
Mario CAMPONE
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario CAMPONE
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Oncologie
Principal Investigator Name
Jérôme MARTIN-BABAU
Principal Investigator Email
j.martin@cario-sante.fr
Contact Person Name
Jérôme MARTIN-BABAU
Contact Person Email
j.martin@cario-sante.fr
Site Name
Institut De Cancerologie De L Ouest (Saint-Herblain)
Department Name
Oncologie
Principal Investigator Name
Mario CAMPONE
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario CAMPONE
Contact Person Email
mario.campone@ico.unicancer.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie
Principal Investigator Name
Florence DALENC
Principal Investigator Email
dalenc.florence@iuct-oncopole.fr
Contact Person Name
Florence DALENC
Site Name
Societe De Recherche Oncologique Clinique 37
Department Name
Oncologie
Principal Investigator Name
Tévy SAN
Principal Investigator Email
t.san@cort37.fr
Contact Person Name
Tévy SAN
Contact Person Email
t.san@cort37.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie
Principal Investigator Name
Nicolas ISAMBERT
Principal Investigator Email
nicolas.isambert@chu-poitiers.fr
Contact Person Name
Nicolas ISAMBERT
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Oncologie
Principal Investigator Name
Aline HOUESSSINON
Principal Investigator Email
Houessinon.aline@chu-amiens.fr
Contact Person Name
Aline HOUESSSINON
Contact Person Email
Houessinon.aline@chu-amiens.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Oncologie
Principal Investigator Name
Dorothée CHOCTEAU-BOUJU
Principal Investigator Email
dr.chocteau@groupeconfluent.fr
Contact Person Name
Dorothée CHOCTEAU-BOUJU
Contact Person Email
dr.chocteau@groupeconfluent.fr
Site Name
Clinique Victor Hugo
Department Name
Oncologie
Principal Investigator Name
Sophie ROCHE
Principal Investigator Email
essaisroche@ilcgroupe.fr
Contact Person Name
Sophie ROCHE
Contact Person Email
essaisroche@ilcgroupe.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Oncologie
Principal Investigator Name
Olfa DERBEL
Principal Investigator Email
o.derbelmermoz@gmail.com
Contact Person Name
Olfa DERBEL
Contact Person Email
o.derbelmermoz@gmail.com
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Oncologie
Principal Investigator Name
Frédéric FITENI
Principal Investigator Email
frederic.fiteni@chu-nimes.fr
Contact Person Name
Frédéric FITENI
Contact Person Email
frederic.fiteni@chu-nimes.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie
Principal Investigator Name
Agathe COCHET
Principal Investigator Email
a.cochet@rennes.unicancer.fr
Contact Person Name
Agathe COCHET
Contact Person Email
a.cochet@rennes.unicancer.fr

Belgium

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
240
Number Of Sites
11
Number Of Participants
62

Sites

Site Name
Chirec
Department Name
Medical Oncology
Principal Investigator Name
Celine Closset
Principal Investigator Email
ceclosset@gmail.com
Contact Person Name
Celine Closset
Contact Person Email
ceclosset@gmail.com
Site Name
Algemeen Ziekenhuis Klina
Department Name
Oncology & Hematology
Principal Investigator Name
Boudewijn Dullens
Principal Investigator Email
boudewijn.dullens@klina.be
Contact Person Name
Boudewijn Dullens
Contact Person Email
boudewijn.dullens@klina.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology & Hematology
Principal Investigator Name
Sarah Lefevre
Principal Investigator Email
sarah.lefevre@ghdc.be
Contact Person Name
Sarah Lefevre
Contact Person Email
sarah.lefevre@ghdc.be
Site Name
Jessa Ziekenhuis
Department Name
Medical Oncology
Principal Investigator Name
Jeroen Mebis
Principal Investigator Email
jeroen.mebis@jessazh.be
Contact Person Name
Jeroen Mebis
Contact Person Email
jeroen.mebis@jessazh.be
Site Name
Institut Jules Bordet
Department Name
Medical Oncology
Principal Investigator Name
Evandro De Azambuja
Principal Investigator Email
evandro.deazambuja@hubruxelles.be
Contact Person Name
Evandro De Azambuja
Site Name
Ziekenhuis Aan De Stroom
Department Name
Medical Oncology
Principal Investigator Name
Kevin Punie
Principal Investigator Email
kevin.punie@zas.be
Contact Person Name
Kevin Punie
Contact Person Email
kevin.punie@zas.be
Site Name
Vitaz
Department Name
Oncology
Principal Investigator Name
Ines Deleu
Principal Investigator Email
ines.deleu@vitaz.be
Contact Person Name
Ines Deleu
Contact Person Email
ines.deleu@vitaz.be
Site Name
CHC MontLegia
Department Name
Medical Oncology
Principal Investigator Name
Marie-Pascale Graas
Principal Investigator Email
marie-pascale.graas@chc.be
Contact Person Name
Marie-Pascale Graas
Contact Person Email
marie-pascale.graas@chc.be
Site Name
UZ Leuven
Department Name
Medical Oncology
Principal Investigator Name
Yannick Van Herck
Principal Investigator Email
yannick.vanherck@uzleuven.be
Contact Person Name
Yannick Van Herck
Contact Person Email
yannick.vanherck@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Medical Oncology
Principal Investigator Name
Karin Schotte
Principal Investigator Email
karin.schotte@azdelta.be
Contact Person Name
Karin Schotte
Contact Person Email
karin.schotte@azdelta.be
Site Name
Algemeen Ziekenhuis Klina (additional site entry)
Department Name
Oncology & Hematology
Principal Investigator Name
Boudewijn Dullens
Principal Investigator Email
boudewijn.dullens@klina.be
Contact Person Name
Boudewijn Dullens
Contact Person Email
boudewijn.dullens@klina.be

Italy

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
106
Number Of Sites
15
Number Of Participants
64

Sites

Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
U.O Oncologia Medica
Principal Investigator Name
Antonella Ferro
Principal Investigator Email
antonella.ferro@apss.tn.it
Contact Person Name
Antonella Ferro
Contact Person Email
antonella.ferro@apss.tn.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOSD Medicina di Precisione in Senologia
Principal Investigator Name
Alessandra Fabi
Principal Investigator Email
alessandra.fabi@policlinicogemelli.it
Contact Person Name
Alessandra Fabi
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology and Hematology
Principal Investigator Name
Claudio Zamagni
Principal Investigator Email
claudio.zamagni@aosp.bo.it
Contact Person Name
Claudio Zamagni
Contact Person Email
claudio.zamagni@aosp.bo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica Sperimentale
Principal Investigator Name
Francesco Giotta
Principal Investigator Email
f.giotta@oncologico.bari.it
Contact Person Name
Francesco Giotta
Contact Person Email
f.giotta@oncologico.bari.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Onco-Hematology, SC Oncology
Principal Investigator Name
Alberto Zambelli
Principal Investigator Email
azambelli@asst-pg23-it
Contact Person Name
Alberto Zambelli
Contact Person Email
azambelli@asst-pg23-it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
UOC Oncologia Clinica Sperimentale di Senologia
Principal Investigator Name
Michelino De Laurentiis
Principal Investigator Email
delauren@breastunit.org
Contact Person Name
Michelino De Laurentiis
Contact Person Email
delauren@breastunit.org
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Radioterapia Oncologica
Principal Investigator Name
Lorenzo Livi
Principal Investigator Email
lorenzo.livi@unifi.it
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
UOC Oncologia Medica
Principal Investigator Name
Grazia Arpino
Principal Investigator Email
grazia.arpino@unina.it
Contact Person Name
Grazia Arpino
Contact Person Email
grazia.arpino@unina.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica 1
Principal Investigator Name
Claudio Verneri
Principal Investigator Email
claudio.vernieri@istitutotumori.mi.it
Contact Person Name
Claudio Verneri
Site Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
SSD Unit- Breast Unit
Principal Investigator Name
Alessandra Beano
Principal Investigator Email
abeano@cittadellasalute.to.it
Contact Person Name
Alessandra Beano
Contact Person Email
abeano@cittadellasalute.to.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica di Oncologia Medica
Principal Investigator Name
Lucia Del Mastro
Principal Investigator Email
lucia.delmastro@hsanmartino.it
Contact Person Name
Lucia Del Mastro
Contact Person Email
lucia.delmastro@hsanmartino.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
SSD DH Oncologico
Principal Investigator Name
Federico Piacentini
Principal Investigator Email
federico.piacentini@unimore.it
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
Medical Oncology
Principal Investigator Name
Francesco Pantano
Principal Investigator Email
f.pantano@policlinicocampus.it
Contact Person Name
Francesco Pantano
Contact Person Email
f.pantano@policlinicocampus.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncologia
Principal Investigator Name
Maria Vita Sanò
Principal Investigator Email
mariavita.sano@humanitascatania.it
Contact Person Name
Maria Vita Sanò
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Medical Oncology
Principal Investigator Name
Antonino Musolino
Principal Investigator Email
antonino.musolino@irst.emr.it
Contact Person Name
Antonino Musolino
Contact Person Email
antonino.musolino@irst.emr.it

Sponsor

Primary sponsor

Full Name
Gilead Sciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
CRO
Name
GBG Forschungs GmbH
Responsibilities
CRO in Europe

Third parties

  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA; IXRS (two entries with Signant addresses and contacts listed for eCOA and IXRS)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"LabCorp Clinical Trials","duties_or_roles":"Laboratory","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Ancillary Vendor","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"GBG Forschungs GmbH","duties_or_roles":"CRO in Europe","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Trodelvy 200 mg powder for concentrate for solution for infusion
Active Substance
sacituzumab govitecan
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation listed (EU/1/21/1592/001)
Starting Dose
10 mg/kg
Maximum Dose
160 mg/kg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation listed (EU/1/15/1024/002)
Starting Dose
200 mg
Frequency
Every 3 weeks (Q3W) (200 mg Q3W is referenced in study text)
Maximum Dose
1600 mg
Investigational Product Name
Xeloda 500 mg film-coated tablets
Active Substance
capecitabine
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Marketing authorisation listed (EU/1/00/163/002)
Maximum Dose
28000 mg/m2 (total amount as listed)
Combination Treatment
Yes

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