Clinical trial • Phase III • Oncology

DATOPOTAMAB DERUXTECAN for Triple-negative breast cancer | Residual invasive breast cancer

Phase III trial of DATOPOTAMAB DERUXTECAN for Triple-negative breast cancer | Residual invasive breast cancer.

Overview

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

Key dates

Initial CTIS Submission Date
17-04-2024
First CTIS Authorization Date
23-05-2024

Trial design

Randomised, open-label, investigator’s choice of therapy (ict) — may include capecitabine (oral) or pembrolizumab (intravenous) as listed comparators; specific doses and schedules not specified in the ctis record.-controlled Phase III trial in Sweden, Spain, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator’s Choice of Therapy (ICT) — may include capecitabine (oral) or pembrolizumab (intravenous) as listed comparators; specific doses and schedules not specified in the CTIS record.
Target Sample Size
797
Trial Duration For Participant
1825

Eligibility

Recruits 797 No vulnerable population selected. Participants must be ≥ 18 years at screening; consent is via adult subject information and informed consent forms (SIS and ICF documents are provided). Separate SIS/ICF documents for pregnant partners and optional genetic/future research are available..

Vulnerable Population
No vulnerable population selected. Participants must be ≥ 18 years at screening; consent is via adult subject information and informed consent forms (SIS and ICF documents are provided). Separate SIS/ICF documents for pregnant partners and optional genetic/future research are available.

Inclusion criteria

  • {"criterion_text":"- 1.Participant must be ≥ 18 years at the time of screening; Male or female\n- 2.Histologically confirmed invasive TNBC\n- 3.Residual invasive disease in the breast and/or axillary lymph node (s) at surgical resection following neoadjuvant therapy\n- 4.Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or taxane with or without platinum chemotherapy, with or without pembrolizumab.\n- 5.No evidence of locoregional or distance relapse\n- 6.Surgical removal of all clinically evident disease in the breast and lymph nodes\n- 7.FFPE tumor sample from residual invasive disease at surgery\n- 8.No adjuvant systemic therapy. Radiotherapy (if indicated) delivered before start of study treatment\n- 9.No more than 6 weeks between completion of post-operative radiation therapy and randomization. If no post-operative radiation therapy, no more than 16 weeks between the date of breast surgery and randomization\n- 10.Eligible for one of the therapy options listed as ICT\n- 11.No known germline BRCA1 or BRCA2 pathogenic mutation\n- 12.Adequate organ and bone marrow function; LVEF ≥ 50% by echocardiogram or MUGA; ECOG 0 or 1"}

Exclusion criteria

  • {"criterion_text":"- 1.Stage IV (metastatic) TNBC\n- 2.History of prior invasive breast cancer or evidence of recurrent disease following preoperative therapy and surgery\n- 3.Prior anticancer therapy with topoisomerase I ADC, TROP2-targeted therapy (e.g., Trodelvy), participated in clinical studies with T-DXd\n- 4.Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab\n- 5.Severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea; infections; active or uncontrolled HBV or HCV uncontrolled HIV; active TB\n- 6.Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤1\n- 7.History of ILD or severe pulmonary function compromise\n- 8.Clinically significant corneal disease\n- 9.Any known active or prior documented autoimmune or inflammatory disorders\n- 10.Any known active liver disease\n- 11.Uncontrolled or significant cardiac disease\n- 12.Grade ≥2 peripheral neuropathy of any etiology\n- 13.History of severe hypersensitivity to either drug substances or inactive ingredients of Dato-DXd or history of hypersensitivity to PD- 1/PD-L1 inhibitors or capecitabine"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Invasive disease-free survival (iDFS), defined as time from randomization until date of first event (local, regional, contralateral or distant breast cancer recurrence, second primary non-breast invasive cancer, or death from any cause. iDFS is based on investigator assessment. Analysis includes all randomised participants, regardless of withdrawal or receipt of another anticancer therapy. Measure of interest is HR of iDFS for Dato-DXd + durvalumab vs ICT.","definition_or_measurement_approach":"Invasive disease-free survival (iDFS), defined as time from randomization until date of first event (local, regional, contralateral or distant breast cancer recurrence, second primary non-breast invasive cancer, or death from any cause). iDFS is based on investigator assessment. Analysis includes all randomised participants, regardless of withdrawal or receipt of another anticancer therapy. Measure of interest is HR of iDFS for Dato-DXd + durvalumab vs ICT."}

Secondary endpoints

  • {"endpoint_text":"- 1. DDFS is defined as time from randomisation to date of the first distant recurrence, occurrence of second primary non-breast invasive cancer (other than squamous or basal cell skin cancer), or death from any cause. DDFS will be determined based on investigator assessment. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. Measure of interest will be HR of DDFS.","definition_or_measurement_approach":"Defined as time from randomisation to date of first distant recurrence, second primary non-breast invasive cancer (excluding squamous or basal cell skin cancer), or death from any cause; investigator assessment; measure of interest HR of DDFS."}
  • {"endpoint_text":"- 2. DDFS for Dato-DXd vs ICT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3. DDFS for Dato-DXd + durvalumab vs Dato-DXd","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 4. Overall Survival (OS): defined as time from randomization until date of death due to any cause. The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. Measure of interest will be the HR of OS for Dato-DXd + durvalumab vs ICT","definition_or_measurement_approach":"OS defined as time from randomization until date of death due to any cause; analysis includes all randomised participants; measure of interest HR of OS for Dato-DXd + durvalumab vs ICT."}
  • {"endpoint_text":"- 5. OS for Dato-DXd vs ICT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 6. iDFS for Dato-DXd vs ICT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 7. iDFS for Dato-DXd + durvalumab vs IC","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 8. Clinical Outcome Assessments (PRO endpoints): Time to Deterioration (TTD) and actual scores: in physical function as measured by the PROMIS Physical Function Short Form 8c and GHS/QoL as measured by the GHS/QoL scale from the EORTC IL172. The measure of interest is the HR of TTD and physical function and GHS/QoL scores for Dato-DXd +/- durvalumab vs ICT","definition_or_measurement_approach":"PROs: Time to Deterioration (TTD) and actual scores using PROMIS Physical Function Short Form 8c and EORTC IL172 GHS/QoL; measure of interest HR of TTD and scores for Dato-DXd +/- durvalumab vs ICT."}
  • {"endpoint_text":"- 9. Fatigue as measured by PROMIS Fatigue Short Form 7a. The measure of interest is the proportion of participants experiencing different levels of fatigue and actual scores at 3, 6, 12 months for Dato-DXd +/- durvalumab vs ICT","definition_or_measurement_approach":"Fatigue measured by PROMIS Fatigue Short Form 7a; measure of interest proportion of participants at different fatigue levels and scores at 3, 6, 12 months."}
  • {"endpoint_text":"- 10. Pharmacokinetics of Dato-DXd","definition_or_measurement_approach":"Assessment of pharmacokinetics of Dato-DXd (PK sampling per protocol)."}
  • {"endpoint_text":"- 11. Immunogenicity of Dato-DXd","definition_or_measurement_approach":"Assessment of immunogenicity of Dato-DXd (anti-drug antibodies etc.)."}
  • {"endpoint_text":"- 12. Safety and tolerability","definition_or_measurement_approach":"Assessment of safety and tolerability (adverse events, laboratory abnormalities, etc.)."}

Recruitment

Planned Sample Size
797
Recruitment Window Months
77
Consent Approach
Informed consent obtained from each adult participant (all participants must be ≥18). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided for adult subjects and for specific situations (pregnant partners, optional genetic research, future research). SIS/ICF documents are available in multiple country/language versions (documents present for Sweden, Spain, Denmark, Italy, Germany, France, Greece, Belgium and language variants including English, Swedish, Spanish, Danish, Italian, German, French, Greek, Dutch).

Methods

  • Patient Study Guide / K2 recruitment material (patient-facing) — patient-facing guides available (documents titled 'K2_Recruitment material Patient Study Guide' in multiple languages) targeted to potential participant patients with TNBC.
  • Posters and advertisements — documents include 'K2_Recruitment material Poster_DE' and 'Advertisements for Subject Recruitment_DE', indicating use of printed/advertisement channels for recruitment (country-specific materials available).
  • Recruitment arrangements documents (K1) — general recruitment arrangements files were submitted per country (e.g., K1_Recruitment arrangements files).

Geography

Total Number Of Sites
87
Total Number Of Participants
269

Sweden

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
23-05-2024
Processing Time Days
14
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Klinisk Forskningsenhet KFE onkologi
Principal Investigator Name
Luisa Edman Kessler
Principal Investigator Email
Luisa.EdmanKessler@capiostgoran.se
Contact Person Name
Luisa Edman Kessler
Site Name
Uppsala University Hospital
Department Name
Kliniska forsknings- och utvecklingsenheten
Principal Investigator Name
Martin Jernling
Principal Investigator Email
martin.jernling@akademiska.se
Contact Person Name
Martin Jernling
Contact Person Email
martin.jernling@akademiska.se
Site Name
Karolinska University Hospital
Department Name
Cancerstudieenheten
Principal Investigator Name
Alexios Matikas
Principal Investigator Email
axions.matikas@ki.se
Contact Person Name
Alexios Matikas
Contact Person Email
axions.matikas@ki.se
Site Name
Region Joenkoepings Laen
Department Name
Onkologkliniken
Principal Investigator Name
Ida Spång Rosén
Principal Investigator Email
ida.spang.rosen@rjl.se
Contact Person Name
Ida Spång Rosén
Contact Person Email
ida.spang.rosen@rjl.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
VO Onkologi
Principal Investigator Name
Barbro Linderholm
Principal Investigator Email
barbro.linderholm@oncology.gu.se
Contact Person Name
Barbro Linderholm
Site Name
Soedersjukhuset AB
Department Name
Onkologiska kliniken
Principal Investigator Name
Ellinor Elinder
Principal Investigator Email
ellinor.elinder@regionstockholm.se
Contact Person Name
Ellinor Elinder
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi, onkologi och strålningsfysik
Principal Investigator Name
Niklas Loman
Principal Investigator Email
niklas.loman@med.lu.se
Contact Person Name
Niklas Loman
Contact Person Email
niklas.loman@med.lu.se
Site Name
Region Vaesternorrland
Department Name
Onkologimottagningen
Principal Investigator Name
Anna-Karin Wennstig
Principal Investigator Email
anna-karin.wennstig@rvn.se
Contact Person Name
Anna-Karin Wennstig
Contact Person Email
anna-karin.wennstig@rvn.se

Spain

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
23-05-2024
Processing Time Days
14
Number Of Sites
10
Number Of Participants
43

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Oncología
Principal Investigator Name
Emilio Alba Conejo
Principal Investigator Email
ealbac@uma.es
Contact Person Name
Emilio Alba Conejo
Contact Person Email
ealbac@uma.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncología
Principal Investigator Name
Eva Ciruelos Gil
Principal Investigator Email
eva.ciruelos@gmail.com
Contact Person Name
Eva Ciruelos Gil
Contact Person Email
eva.ciruelos@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncología
Principal Investigator Name
Mafalda Oliveira
Principal Investigator Email
moliveira@vhio.net
Contact Person Name
Mafalda Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Servicio de Oncología
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 De Elche
Department Name
Servicio de Oncología
Principal Investigator Name
Álvaro Rodríguez Lescure
Principal Investigator Email
onkopinha@gmail.com
Contact Person Name
Álvaro Rodríguez Lescure
Contact Person Email
onkopinha@gmail.com
Site Name
University Hospital Son Espases
Department Name
Servicio de Oncología
Principal Investigator Name
Antonia Perelló Martorell
Principal Investigator Email
antonia.perellom@ssib.es
Contact Person Name
Antonia Perelló Martorell
Contact Person Email
antonia.perellom@ssib.es
Site Name
Hospital Universitario De Toledo
Department Name
Oncology
Principal Investigator Name
Ana María García Tapiador
Principal Investigator Email
amgarciat@sescam.jccm.es
Contact Person Name
Ana María García Tapiador
Contact Person Email
amgarciat@sescam.jccm.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de Oncología
Principal Investigator Name
Begoña Bermejo de las Heras
Principal Investigator Email
bermejo_beg@gva.es
Contact Person Name
Begoña Bermejo de las Heras
Contact Person Email
bermejo_beg@gva.es
Site Name
Hospital Clinico San Carlos
Department Name
Servicio de Oncología Médica
Principal Investigator Name
José Angel García Sáenz
Principal Investigator Email
jgsaenz@salud.madrid.org
Contact Person Name
José Angel García Sáenz
Contact Person Email
jgsaenz@salud.madrid.org
Site Name
Hospital Universitario Basurto
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Elena Galve Calvo
Principal Investigator Email
ELENA.GALVECALVO@osakidetza.eus
Contact Person Name
Elena Galve Calvo

Denmark

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
23-05-2024
Processing Time Days
14
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Region Hovedstaden
Department Name
Onkologisk Afdeling
Principal Investigator Name
Iben Kümler
Principal Investigator Email
ibekml01@regionh.dk
Contact Person Name
Iben Kümler
Contact Person Email
ibekml01@regionh.dk
Site Name
Rigshospitalet
Department Name
Oncology
Principal Investigator Name
Christina Bjerre
Principal Investigator Email
christina.annette.bjerre@regionh.dk
Contact Person Name
Christina Bjerre
Site Name
Region Midtjylland
Department Name
Kræftklinikken
Principal Investigator Name
Troels Bechmann
Principal Investigator Email
trobec@rm.dk
Contact Person Name
Troels Bechmann
Contact Person Email
trobec@rm.dk
Site Name
Næstved Hospital
Department Name
Onkologisk Afdeling
Principal Investigator Name
Anne-Cathrine Bareid Østby
Principal Investigator Email
anboe@regionsjaelland.dk
Contact Person Name
Anne-Cathrine Bareid Østby
Contact Person Email
anboe@regionsjaelland.dk
Site Name
Lillebaelt Hospital
Department Name
Onkologisk afdeling
Principal Investigator Name
Lone Marie Volmer
Principal Investigator Email
Lone.Volmer@rsyd.dk
Contact Person Name
Lone Marie Volmer
Contact Person Email
Lone.Volmer@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Onkologisk Afdeling
Principal Investigator Name
Anders Krog Vistisen
Principal Investigator Email
ankrv@rn.dk
Contact Person Name
Anders Krog Vistisen
Contact Person Email
ankrv@rn.dk
Site Name
Sygehus Soenderjylland Soenderborg
Department Name
Kræftambulatoriet
Principal Investigator Name
Erik Hugger Jakobsen
Principal Investigator Email
Erik.Hugger.Jakobsen@rsyd.dk
Contact Person Name
Erik Hugger Jakobsen
Contact Person Email
Erik.Hugger.Jakobsen@rsyd.dk
Site Name
Odense University Hospital
Department Name
Onkologisk afdeling
Principal Investigator Name
Jeanette Dupont Jensen
Principal Investigator Email
jeanette.dupont.roenlov@rsyd.dk
Contact Person Name
Jeanette Dupont Jensen

Italy

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
20
Number Of Sites
15
Number Of Participants
44

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Clnical Unit, Medical Oncology Department
Principal Investigator Name
Filippo Merloni
Principal Investigator Email
filippo.merloni@irst.emr.it
Contact Person Name
Filippo Merloni
Contact Person Email
filippo.merloni@irst.emr.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncology Department
Principal Investigator Name
Rebecca Pedersini
Principal Investigator Email
rebecca.pedersini@gmail.com
Contact Person Name
Rebecca Pedersini
Contact Person Email
rebecca.pedersini@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology and Haematology
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
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Oncology Department
Principal Investigator Name
Ferdinando Riccardi
Principal Investigator Email
ferdinando.riccardi@aocardarelli.it
Contact Person Name
Ferdinando Riccardi
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Division of Medical Senology
Principal Investigator Name
Marco Colleoni
Principal Investigator Email
marco.colleoni@ieo.it
Contact Person Name
Marco Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze della Salute della donna, del bambino e di sanita pubblica
Principal Investigator Name
Alessandra Fabi
Principal Investigator Email
alessandra.fabi@policlinicogemelli.it
Contact Person Name
Alessandra Fabi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Medical Oncology
Principal Investigator Name
Giampaolo Bianchini
Principal Investigator Email
bianchini.giampaolo@hsr.it
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it
Site Name
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department Name
U.O.C. Medical Oncology
Principal Investigator Name
Luigi Coltelli
Principal Investigator Email
luigi.coltelli@uslnordovest.toscana.it
Contact Person Name
Luigi Coltelli
Site Name
Humanitas Research Hospital
Department Name
Department of Medicai Oncology and Hematology, Humanitas Research Hospital
Principal Investigator Name
Giuseppe Saltalamacchia
Contact Person Name
Giuseppe Saltalamacchia
Site Name
Careggi University Hospital
Department Name
Department of Biomedical, Experimental and Clinical Sciences
Principal Investigator Name
Icro Meattini
Principal Investigator Email
icro.meattini@unifi.it
Contact Person Name
Icro Meattini
Contact Person Email
icro.meattini@unifi.it
Site Name
Azienda Ospedaliera Papardo
Department Name
Medical Oncology Department
Principal Investigator Name
Giuseppina Ricciardi
Principal Investigator Email
giusyricciardi81@hotmail.it
Contact Person Name
Giuseppina Ricciardi
Contact Person Email
giusyricciardi81@hotmail.it
Site Name
Istituto Oncologico Veneto
Department Name
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Istituto Nazionale Dei Tumori
Department Name
Oncology Division
Principal Investigator Name
Michelino De Laurentiis
Principal Investigator Email
m.delaurentiis@istitutotumori.na.It
Contact Person Name
Michelino De Laurentiis
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Medical Oncology Unit
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

Germany

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
15
Number Of Sites
15
Number Of Participants
56

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department für Frauengesundheit Universitäts-Frauenklinik
Principal Investigator Name
Andreas Hartkopf
Principal Investigator Email
Andreas.Hartkopf@med.uni-tuebingen.de
Contact Person Name
Andreas Hartkopf
Site Name
Vivantes MVZ GmbH
Department Name
Brustzentrum, Klinikum Am Urban
Principal Investigator Name
Claudia Gerber-Schäfer
Principal Investigator Email
Claudia.Gerber-Schaefer@vivantes.de
Contact Person Name
Claudia Gerber-Schäfer
Site Name
Klinikum Frankfurt Hoechst GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
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
Klinikum der Universitaet Muenchen AöR
Department Name
Ludwig-Maximilians-Universität- Campus Großhadern
Principal Investigator Name
Nadia Harbeck
Principal Investigator Email
nadia.harbeck@med.uni-muenchen.de
Contact Person Name
Nadia Harbeck
Site Name
Mammazentrum Hamburg MVZ GbR
Department Name
Operative Therapie und Onkologie
Principal Investigator Name
Christian Schem
Principal Investigator Email
schem@mammazentrum.eu
Contact Person Name
Christian Schem
Contact Person Email
schem@mammazentrum.eu
Site Name
Praxisnetzwerk Haematologie and internistische Onkologie Ueberoertliche Berufsausuebungsgemeinschaft
Principal Investigator Name
Helmut Forstbauer
Principal Investigator Email
forstbauer@onkologie-rheinsieg.de
Contact Person Name
Helmut Forstbauer
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Stephan Seitz
Principal Investigator Email
sseitz@csj.de
Contact Person Name
Stephan Seitz
Contact Person Email
sseitz@csj.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Frauenklinik
Principal Investigator Name
Nikolaus de Gregorio
Principal Investigator Email
nikolaus.degregorio@slk-kliniken.de
Contact Person Name
Nikolaus de Gregorio
Site Name
St. Vincenz-Krankenhaus GmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe Kooperatives Brustzentrum Paderborn
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
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Claudia Hänle
Principal Investigator Email
claudia.haenle@rkh-gesundheit.de
Contact Person Name
Claudia Hänle
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Campus Kiel - Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie)
Principal Investigator Name
Marion van Mackelenbergh
Principal Investigator Email
marion.vanmackelenbergh@uksh.de
Contact Person Name
Marion van Mackelenbergh
Site Name
Vinzenz Von Paul Kliniken gGmbH
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
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Principal Investigator Name
Roswitha Fuchs
Principal Investigator Email
dr.fuchs@onkologie-langen.de
Contact Person Name
Roswitha Fuchs
Contact Person Email
dr.fuchs@onkologie-langen.de
Site Name
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
Principal Investigator Name
Oleg Gluz
Principal Investigator Email
oleg.gluz@brustzentrum-rhein-ruhr.com
Contact Person Name
Oleg Gluz

France

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
29
Number Of Sites
13
Number Of Participants
30

Sites

Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncologie Médicale
Principal Investigator Name
Cristian Villanueva
Principal Investigator Email
villanueva@ccgm.fr
Contact Person Name
Cristian Villanueva
Contact Person Email
villanueva@ccgm.fr
Site Name
Medipole De Nancy
Department Name
Oncologie Médicale
Principal Investigator Name
Dominique Spaeth
Principal Investigator Email
d.spaeth@ilcgroupe.fr
Contact Person Name
Dominique Spaeth
Contact Person Email
d.spaeth@ilcgroupe.fr
Site Name
Universite De Poitiers
Department Name
Oncologie Médicale
Principal Investigator Name
Nicolas Isambert
Principal Investigator Email
Nicolas.ISAMBERT@chu-poitiers.fr
Contact Person Name
Nicolas Isambert
Site Name
Institut Gustave Roussy
Department Name
Oncologie Médicale
Principal Investigator Name
Barbara Pistilli
Principal Investigator Email
BARBARA.PISTILLI@gustaveroussy.fr
Contact Person Name
Barbara Pistilli
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Médicale
Principal Investigator Name
Anne Patsouris
Principal Investigator Email
Anne.Patsouris@ico.unicancer.fr
Contact Person Name
Anne Patsouris
Site Name
Institut Bergonie
Department Name
Oncologie Médicale
Principal Investigator Name
Laura Salabert
Principal Investigator Email
l.salabert@bordeaux.unicancer.fr
Contact Person Name
Laura Salabert
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Oncologie Médicale
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
Institut De Cancerologie De Bourgogne
Department Name
Oncologie Médicale
Principal Investigator Name
Véronique Lorgis
Principal Investigator Email
vlorgis@icb-cancer.fr
Contact Person Name
Véronique Lorgis
Contact Person Email
vlorgis@icb-cancer.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Oncologie Médicale
Principal Investigator Name
Laetitia Stefani
Principal Investigator Email
lstefani@ch-annecygenevois.fr
Contact Person Name
Laetitia Stefani
Contact Person Email
lstefani@ch-annecygenevois.fr
Site Name
Institut De Cancerologie De L Ouest (St Herblain)
Department Name
Oncologie Médicale
Principal Investigator Name
Jean-Sebastien Frenel
Principal Investigator Email
Jean-Sebastien.Frenel@ico.unicancer.fr
Contact Person Name
Jean-Sebastien Frenel
Site Name
Hopital Prive Jean Mermoz
Department Name
Oncologie Médicale
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 De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie Médicale
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
Site Name
Institut Curie
Department Name
Oncologie Médicale
Principal Investigator Name
Delphine Loirat
Principal Investigator Email
delphine.loirat@curie.fr
Contact Person Name
Delphine Loirat
Contact Person Email
delphine.loirat@curie.fr

Belgium

Earliest CTIS Part Ii Submission Date
09-05-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
15
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
GasthuisZusters Antwerpen
Department Name
Oncology
Principal Investigator Name
Kevin Punie
Principal Investigator Email
kevin.punie@gza.be
Contact Person Name
Kevin Punie
Contact Person Email
kevin.punie@gza.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Service d'oncologie médicale
Principal Investigator Name
Joëlle Collignon
Principal Investigator Email
joelle.collignon@chuliege.be
Contact Person Name
Joëlle Collignon
Contact Person Email
joelle.collignon@chuliege.be
Site Name
Vitaz
Department Name
Medische oncologie
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
Jessa Ziekenhuis
Department Name
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
Grand Hopital De Charleroi
Department Name
Oncology
Principal Investigator Name
Jean-Luc Canon
Principal Investigator Email
Jean-Luc.Canon@ghdc.be
Contact Person Name
Jean-Luc Canon
Contact Person Email
Jean-Luc.Canon@ghdc.be
Site Name
UZ Brussel
Department Name
Medische oncologie
Principal Investigator Name
Christel Fontaine
Principal Investigator Email
christel.fontaine@uzbrussel.be
Contact Person Name
Christel Fontaine
Contact Person Email
christel.fontaine@uzbrussel.be
Site Name
Antwerp University Hospital
Department Name
Oncologie
Principal Investigator Name
Konstantinos Papadimitriou
Principal Investigator Email
konstantinos.papadimitriou@uza.be
Contact Person Name
Konstantinos Papadimitriou
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Clinique du sein / Oncology – Breast Clinic
Principal Investigator Name
Cédric Van Marcke De Lummen
Principal Investigator Email
cedric.vanmarcke@saintluc.uclouvain.be
Contact Person Name
Cédric Van Marcke De Lummen
Site Name
Cliniques Universitaires Saint-Luc (duplicate entry in list?)
Department Name
Clinique du sein / Oncology – Breast Clinic
Site Name
Cliniques/CHC MontLegia
Department Name
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
Institut Jules Bordet
Department Name
Oncologie médicale
Principal Investigator Name
Michail Ignatiadis
Principal Investigator Email
michail.Ignatiadis@bordet.be
Contact Person Name
Michail Ignatiadis
Contact Person Email
michail.Ignatiadis@bordet.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
C3 Hôpital de Jour
Principal Investigator Name
Stéphanie Henry
Principal Investigator Email
stephanie.henry@chuuclnamur.uclouvain.be
Contact Person Name
Stéphanie Henry

Greece

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
34
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Alexandra Hospital
Department Name
Therapeutic Clinic
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
St Savas Hospital
Department Name
2nd Internal Medicine Department Oncology Clinic
Principal Investigator Name
Dimitrios Tryfonopoulos
Principal Investigator Email
tryfonopoulos@hotmail.com
Contact Person Name
Dimitrios Tryfonopoulos
Contact Person Email
tryfonopoulos@hotmail.com
Site Name
Theageneio Cancer Hospital
Department Name
3rd Internal Medicine Oncology Clinic
Principal Investigator Name
Efthalia Lalla
Principal Investigator Email
thaleia.lalla@gmail.com
Contact Person Name
Efthalia Lalla
Contact Person Email
thaleia.lalla@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Konstantinos Papazisis
Principal Investigator Email
konstantinos.papazisis@gmail.com
Contact Person Name
Konstantinos Papazisis
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
4th Department of Internal Medicine
Principal Investigator Name
Anna Koumarianou
Principal Investigator Email
akoumari@yahoo.gr
Contact Person Name
Anna Koumarianou
Contact Person Email
akoumari@yahoo.gr
Site Name
University General Hospital Of Heraklion
Department Name
Oncology Clinic
Principal Investigator Name
Dimitrios Mavroudis
Principal Investigator Email
mavroudis@uoc.gr
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
mavroudis@uoc.gr

Sponsor

Primary sponsor

Full Name
Astrazeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Investigational (no marketing authorisation indicated)
Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion.
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/18/1322/001)
Combination Treatment
Yes

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