Clinical trial • Phase III • Oncology

Trastuzumab deruxtecan for Endometrial cancer (HER2-expressing)

Phase III trial of Trastuzumab deruxtecan for Endometrial cancer (HER2-expressing).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Endometrial cancer (HER2-expressing)
Trial Stage
Phase III
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
22-08-2025
First CTIS Authorization Date
11-12-2025

Trial design

Randomised, open-label, standard of care chemotherapy (comparator arms): docetaxel (max 75 mg/m2 iv), paclitaxel (max 175 mg/m2 iv infusion), cisplatin (max 50 mg/m2 iv), carboplatin (max 750 mg iv) administered per local standard-of-care; radiotherapy may be given with or without chemotherapy as per local practice.-controlled Phase III trial in Greece, Italy, Portugal and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of care chemotherapy (comparator arms): Docetaxel (max 75 mg/m2 IV), Paclitaxel (max 175 mg/m2 IV infusion), Cisplatin (max 50 mg/m2 IV), Carboplatin (max 750 mg IV) administered per local standard-of-care; radiotherapy may be given with or without chemotherapy as per local practice.
Target Sample Size
510

Eligibility

Recruits 510 Adults only: Adults ≥18 years at time of ICF signature; follow local regulatory requirements if the legal age of consent for trial participation is >18 years. No vulnerable populations selected in the CTIS record..

Vulnerable Population
Adults only: Adults ≥18 years at time of ICF signature; follow local regulatory requirements if the legal age of consent for trial participation is >18 years. No vulnerable populations selected in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Sign and date the Tissue SCR ICF, prior to HER2 central testing. Sign and date the main SCR ICFs, prior to the start of any trial-specific qualification procedures not included in the Tissue SCR ICF. Consent to optional PGx prior to any PGx procedures.\n- Is disease-free with no evidence of loco-regional disease or distant metastasis post- operatively on imaging assessed by investigator and confirmed by BICR.\n- Trial intervention to start within 8 weeks of endometrial cancer surgery date\n- Has not received any radiotherapy or systemic therapy, including immunotherapy, hormonal therapy, radiosensitizer chemotherapy or HIPEC, in any setting including the neoadjuvant setting for endometrial cancer.\n- Has LVEF ≥ 50% within 28 days before randomization.\n- ECOG performance status of 0 or 1 assessed no more than 14 days prior to randomization.\n- Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to randomization as defined in the protocol. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 72 hours of initiation of trial intervention as appropriate.\n- Has adequate treatment washout period before randomization as defined in the protocol.\n- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures and trial restrictions.\n- Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old)\n- Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology’s are allowed except for sarcomas (carcinosarcomas are allowed).\n- Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III\n- Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing.\n- Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory.\n- Has an MMR IHC local test result from an approved and/or validated test, according to the local regulations.\n- Is eligible for combination treatment with carboplatin and paclitaxel as adjuvant therapy per SoC and Investigator discretion\n- Has undergone curative intent surgery that included hysterectomy and bilateral salpingo- oophorectomy. Pelvic lymph node sampling, para-aortic lymph node sampling, including sentinel lymph node, and lymph node dissection are optional but strongly encouraged."}

Exclusion criteria

  • {"criterion_text":"- Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.\n- History of other active malignancy within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate >90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ).\n- History of hypersensitivity to the trial intervention or their excipients or any known contraindication (included in the approved local labels) to treatment with, including hypersensitivity to, the trial intervention.\n- History of severe hypersensitivity reactions to other monoclonal antibodies.\n- Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that, in the Investigator's opinion, make it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol. SCR for chronic conditions is not required.\n- Has an uncontrolled infection requiring systemic antibiotics, antivirals or antifungals. Participant with localized fungal infections of skin or nails are eligible.\n- Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required. Please see the protocol for more details.\n- Has active or uncontrolled hepatitis C virus infection. Hepatitis C SCR testing is required. Please see the protocol for more details.\n- Has active or uncontrolled HIV infection. Participants must be tested for HIV viral load during the SCR Period if acceptable by local regulations or IRBs/IECs. Please see the protocol for more details.\n- Psychological, social, familial, or geographical factors that would prevent regular follow up.\n- Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator’s opinion, could affect the safety of the participant; alter the absorption, distribution, metabolism, or excretion of the trial intervention; or confound the assessment of trial results.\n- Has recurrent or FIGO 2023 Stage IV.\n- Has a history of receiving live-attenuated vaccine (mRNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to trial intervention.\n- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline. Please see the protocol for more details.\n- Has measurable residual tumor after surgery as determined by BICR assessment.\n- Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available\n- Has a medical history of MI within 6 months before randomization/enrollment, symptomatic CHF (NYHA Class II to IV). Participants with Troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI.\n- Has a QTcF prolongation to > 480 msec based on average of the SCR triplicate12-lead ECG.\n- Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n- Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR.\n- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc.), or prior pneumonectomy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- DFS is defined as time interval from the date of randomization to the first documented local-regional recurrence, distant metastasis, or death due to any cause, whichever occurs first. DFS will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.","definition_or_measurement_approach":"DFS defined as time from randomization to first documented local-regional recurrence, distant metastasis, or death from any cause; assessed radiographically by BICR or by histopathologic confirmation per local assessment."}

Secondary endpoints

  • {"endpoint_text":"- OS is defined as the time interval from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"OS defined as time from randomization to date of death from any cause."}
  • {"endpoint_text":"- DFS is defined as the time from randomization to the first documented local-regional recurrence, distant metastasis or death due to any cause, whichever occurs first. DFS will be assessed radiographically by investigator or by histopathologic confirmation of disease recurrence per local assessment.","definition_or_measurement_approach":"DFS as above; assessed radiographically by investigator or by histopathologic confirmation per local assessment."}
  • {"endpoint_text":"- Distant metastatic recurrence is defined as recurrence outside of vagina, pelvis, or pelvic lymph nodes.","definition_or_measurement_approach":"Distant metastatic recurrence defined as recurrence outside vagina, pelvis, or pelvic lymph nodes; assessed radiologically by BICR or histopathology/local assessment as applicable."}
  • {"endpoint_text":"- Local recurrence is defined as recurrence in the vagina as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment","definition_or_measurement_approach":"Local recurrence = recurrence in the vagina; assessed radiologically by BICR or by histopathologic confirmation per local assessment."}
  • {"endpoint_text":"- Regional recurrence is defined as recurrence in the pelvis or pelvic lymph nodes as assessed radiologically by BICR or by histopathologic confirmation of disease recurrence per local assessment","definition_or_measurement_approach":"Regional recurrence = recurrence in pelvis or pelvic lymph nodes; assessed radiologically by BICR or by histopathologic confirmation per local assessment."}
  • {"endpoint_text":"- Incidence of TEAEs, SAEs, TEAEs associated with dose modifications, AESIs, TEAEs with death outcome, and changes from baseline in vital signs, clinical laboratory results, ECGs, ECHO/MUGA, and ophthalmologic assessments","definition_or_measurement_approach":"Safety endpoints: incidence counts of treatment-emergent AEs (TEAEs), serious AEs (SAEs), TEAEs leading to dose modifications, adverse events of special interest (AESIs), TEAEs with fatal outcome; and changes from baseline in vital signs, labs, ECG, ECHO/MUGA, ophthalmologic assessments."}
  • {"endpoint_text":"- Change from baseline and time to deterioration for the following PRO questionnaire: EORTC QLQ-C30 GHS/overall QoL, physical","definition_or_measurement_approach":"PRO endpoints: change from baseline and time to deterioration on EORTC QLQ-C30 global health status/overall QoL and physical functioning subscales."}
  • {"endpoint_text":"- Change from baseline and time to deterioration for the following PRO questionnaires: EORTC QLQ-EN24: Back and pelvic pain (ENBP), tingling/numbness (ENTN), muscular pain (ENM)","definition_or_measurement_approach":"PRO endpoints (EORTC QLQ-EN24): change from baseline and time to deterioration for specified symptom scales (ENBP, ENTN, ENM)."}
  • {"endpoint_text":"- Serum concentrations of T-DXd, total anti-HER2 antibody and DXd.","definition_or_measurement_approach":"PK endpoints: serum concentrations of T-DXd, total anti-HER2 antibody and DXd measured in plasma/serum at scheduled PK timepoints."}
  • {"endpoint_text":"- ADA incidence: The proportion of participants having treatment-emergent ADA. Titer and nAb may be determined when ADA is positive.","definition_or_measurement_approach":"Immunogenicity endpoint: proportion of participants with treatment-emergent anti-drug antibodies (ADA); titers and neutralizing antibody assessment (nAb) when ADA positive."}

Recruitment

Digital Remote Recruitment
True, Digital/remote methods include Digital Toolkit Access Cards for pre-enrolment, digital pre-enrolment information cards, and electronic patient-facing materials; ePRO and digital data capture (central imaging and ePRO services referenced).
Planned Sample Size
510
Recruitment Window Months
75
Consent Approach
Informed consent obtained by signing and dating appropriate ICFs: Tissue Screening ICF (prior to central HER2 testing) and main ICF(s) prior to any trial-specific qualification procedures. Consent to optional PGx required prior to PGx procedures. Participants must be adults (≥18 years) at time of ICF signature; local regulatory requirements followed if legal age of consent >18. Subject information and consent materials provided in multiple languages (e.g., English, French, Spanish, Italian, Polish, Portuguese, Greek, German as per available patient-facing documents).

Methods

  • Physician referral letters (Dr-to-Patient / Physician Referral Letter) distributed to clinicians to identify and refer eligible patients; country-specific versions prepared.
  • Patient brochures and study information leaflets (Patient Brochure, Study Information for Potential Participants) provided to potential participants in clinic.
  • Participant-facing materials: Participant Welcome Letter, Participant Study Guide, Participant ID Card, Visit Reminder Card, Thank You Card to support retention and communication.
  • Digital Toolkit / Digital Toolkit Access Card and Pre-Enrollment Info Cards to provide digital pre-enrolment study information and access (digital materials present across multiple countries).
  • Study information and informed consent forms (Tissue SCR ICF, Main ICF) provided prior to screening; optional PGx consent materials provided for optional pharmacogenomics procedures.
  • Physician-to-patient letters and referral templates (Dr-to-Patient Letter, Physician Referral Letter) to engage clinicians and support recruitment.

Geography

Total Number Of Sites
68
Total Number Of Participants
200

Greece

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
231
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
Department Name
1st Oncology Clinic
Principal Investigator Name
Christos Papadimitriou
Principal Investigator Email
chr_papadim@yahoo.gr
Contact Person Name
Christos Papadimitriou
Contact Person Email
chr_papadim@yahoo.gr
Site Name
Aretaieio Hospital, National and Kapodistrian University of Athens
Department Name
, B’ Surgery clinic, Oncology unit
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
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
D’ Internal Medicine Clinic
Principal Investigator Name
Anna Koumarianou
Principal Investigator Email
akoumari@yahoo.com
Contact Person Name
Anna Koumarianou
Contact Person Email
akoumari@yahoo.com
Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics
Principal Investigator Name
Michail Liontos
Principal Investigator Email
mliontos@gmail.com
Contact Person Name
Michail Liontos
Contact Person Email
mliontos@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Principal Investigator Name
Eleni Fountzila
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Mitera S.A.
Department Name
2nd Medical Oncology Department
Principal Investigator Name
Ioannis Syrios
Principal Investigator Email
syriosi@yahoo.gr
Contact Person Name
Ioannis Syrios
Contact Person Email
syriosi@yahoo.gr

Italy

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
174
Number Of Sites
17
Number Of Participants
30

Sites

Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica SS Genitourinario
Principal Investigator Name
Marica Gentile
Principal Investigator Email
m.gentile@oncologico.bari.it
Contact Person Name
Marica Gentile
Contact Person Email
m.gentile@oncologico.bari.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
UOC Oncologia Medica
Principal Investigator Name
Roberto Bianco
Principal Investigator Email
robianco@unina.it
Contact Person Name
Roberto Bianco
Contact Person Email
robianco@unina.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncologia Medica
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
Alessandro Manzoni Hospital
Department Name
Oncologia
Principal Investigator Name
Alessandra Crippa
Principal Investigator Email
a.crippa@asst-lecco.it
Contact Person Name
Alessandra Crippa
Contact Person Email
a.crippa@asst-lecco.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Oncologia Ginecologica
Principal Investigator Name
Maria Cristina Petrella
Principal Investigator Email
petrellamc@aou-careggi.toscana.it
Contact Person Name
Maria Cristina Petrella
Site Name
Azienda Sanitaria Locale Della Provincia Di Biella
Department Name
Oncologia
Principal Investigator Name
Laura Zavallone
Principal Investigator Email
laura.zavallone@aslbi.piemonte.it
Contact Person Name
Laura Zavallone
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ginecologia Oncologica
Principal Investigator Name
Anna Fagotti
Principal Investigator Email
anna.fagotti@policlinicogemelli.it
Contact Person Name
Anna Fagotti
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Ostetricia Ginecologia
Principal Investigator Name
Germana Tognon
Principal Investigator Email
germanatognon@gmail.com
Contact Person Name
Germana Tognon
Contact Person Email
germanatognon@gmail.com
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncologia Medica
Principal Investigator Name
Stefania Canova
Principal Investigator Email
stefania.canova@irccs-sangerardo.it
Contact Person Name
Stefania Canova
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Sperimentale Uro-Ginecologica
Principal Investigator Name
Carmela Pisano
Principal Investigator Email
c.pisano@istitutotumori.na.it
Contact Person Name
Carmela Pisano
Contact Person Email
c.pisano@istitutotumori.na.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Ginecologia Oncologica
Principal Investigator Name
Domenica Lorusso
Principal Investigator Email
domenica.lorusso@hunimed.eu
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Ginecologia Oncologica
Principal Investigator Name
Francesco Raspagliesi
Principal Investigator Email
raspagliesi@istitutotumori.mi.it
Contact Person Name
Francesco Raspagliesi
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Principal Investigator Name
Valentina Guarnieri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarnieri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Ginecologia Oncologica
Principal Investigator Name
Nicoletta Colombo
Principal Investigator Email
nicoletta.colombo@ieo.it
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
San Raffaele Hospital
Department Name
Ginecologia Ostetricia
Principal Investigator Name
Giorgia Mangili
Principal Investigator Email
mangili.giorgia@hsr.it
Contact Person Name
Giorgia Mangili
Contact Person Email
mangili.giorgia@hsr.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Oncologia Ginecologica
Principal Investigator Name
Annamaria Ferrero
Principal Investigator Email
annamaria.ferrero@unito.it
Contact Person Name
Annamaria Ferrero
Contact Person Email
annamaria.ferrero@unito.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncologia Medica Provinciale
Principal Investigator Name
Alessandra Bologna
Principal Investigator Email
alessandra.bologna@ausl.re.it
Contact Person Name
Alessandra Bologna
Contact Person Email
alessandra.bologna@ausl.re.it

Portugal

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
174
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Principal Investigator Name
Monica Nave
Principal Investigator Email
mnave@hospitaldaluz.pt
Contact Person Name
Monica Nave
Contact Person Email
mnave@hospitaldaluz.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Oncology
Principal Investigator Name
Joana Rodrigues
Principal Investigator Email
rodrigues.joana.mc@gmail.com
Contact Person Name
Joana Rodrigues
Contact Person Email
rodrigues.joana.mc@gmail.com
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Oncology
Principal Investigator Name
Cristiana Marques
Principal Investigator Email
cristiana.marques@chvng.min-saude.pt
Contact Person Name
Cristiana Marques
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Principal Investigator Name
Miguel Abreu
Principal Investigator Email
antonio.m.abreu@ipoporto.min-saude.pt
Contact Person Name
Miguel Abreu

Germany

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
203
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung Loc. 1
Department Name
Klinik für Gynäkologie & Gyn. Onkologie
Principal Investigator Name
Julia Welz
Principal Investigator Email
j.welz@kem-med.com
Contact Person Name
Julia Welz
Contact Person Email
j.welz@kem-med.com
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Sabine Heublein
Principal Investigator Email
Sabine.heublein@uniklinik-ulm.de
Contact Person Name
Sabine Heublein
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Tanja Fehm
Principal Investigator Email
tanja.fehm@med.uni-duesseldorf.de
Contact Person Name
Tanja Fehm
Site Name
UNIVERSITÄTSKLINIKUM FREIBURG
Department Name
Klinik für Frauenheilkunde
Principal Investigator Name
Beate Rautenberg
Principal Investigator Email
Beate.rautenberg@uniklinik-freiburg.de
Contact Person Name
Beate Rautenberg
Site Name
Goethe University Frankfurt
Department Name
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Principal Investigator Name
Maximilian Rost
Principal Investigator Email
rost@med.uni-frankfurt.de
Contact Person Name
Maximilian Rost
Contact Person Email
rost@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
Pauline.Wimberger@ukdd.de
Contact Person Name
Pauline Wimberger
Contact Person Email
Pauline.Wimberger@ukdd.de
Site Name
Klinikum Lippe GmbH
Principal Investigator Name
Beyhan Ataseven
Principal Investigator Email
Beyhan.ataseven@klinikum-lippe.de
Contact Person Name
Beyhan Ataseven
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Principal Investigator Name
Barbara Schmalfeldt
Principal Investigator Email
b.schmalfeldt@uke.de
Contact Person Name
Barbara Schmalfeldt
Contact Person Email
b.schmalfeldt@uke.de

France

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
195
Number Of Sites
15
Number Of Participants
35

Sites

Site Name
Centre Francois Baclesse
Department Name
Oncologie
Principal Investigator Name
Florence Joly
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie
Principal Investigator Name
Thibault De La Motte Rouge
Principal Investigator Email
t.delamotterouge@rennes.unicancer.fr
Contact Person Name
Thibault De La Motte Rouge
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie
Principal Investigator Name
Philippe Follana
Principal Investigator Email
philippe.follana@nice.unicancer.fr
Contact Person Name
Philippe Follana
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncologie
Principal Investigator Name
Emmanuel Guardiola
Principal Investigator Email
guardiola@ccgm.fr
Contact Person Name
Emmanuel Guardiola
Contact Person Email
guardiola@ccgm.fr
Site Name
Institut Bergonie
Department Name
Oncologie
Principal Investigator Name
Coriolan Lebreton
Principal Investigator Email
c.lebreton@bordeaux.unicancer.fr
Contact Person Name
Coriolan Lebreton
Site Name
L'Hopital Prive Du Confluent
Department Name
Oncologie
Principal Investigator Name
Cyriac BLONZ
Principal Investigator Email
blonz.cyriac@groupeconfluent.fr
Contact Person Name
Cyriac BLONZ
Site Name
Centre Jean Perrin
Department Name
Oncologie
Principal Investigator Name
Elsa Kalbacher
Principal Investigator Email
elsa.kalbacher@clermont.unicancer.fr
Contact Person Name
Elsa Kalbacher
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncologie
Principal Investigator Name
Lauriane Ebesrt
Principal Investigator Email
l.eberst@icans.eu
Contact Person Name
Lauriane Ebesrt
Contact Person Email
l.eberst@icans.eu
Site Name
Centre Oscar Lambret
Department Name
Oncologie
Principal Investigator Name
Cyril Abdeddaim
Principal Investigator Email
c-abdeddaim@o-lambert.fr
Contact Person Name
Cyril Abdeddaim
Contact Person Email
c-abdeddaim@o-lambert.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncologie
Principal Investigator Name
Laura Deiana
Principal Investigator Email
laura.deiana@chu-brest.fr
Contact Person Name
Laura Deiana
Contact Person Email
laura.deiana@chu-brest.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie
Principal Investigator Name
Laurence Gladieff
Principal Investigator Email
gladieff.laurence@iuct-oncolope.fr
Contact Person Name
Laurence Gladieff
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Oncologie
Principal Investigator Name
Bertrand Billemont
Principal Investigator Email
b.billemont@isc84.org
Contact Person Name
Bertrand Billemont
Contact Person Email
b.billemont@isc84.org
Site Name
CHU Besancon
Department Name
Oncologie
Principal Investigator Name
Laura Mansi
Principal Investigator Email
lmansi@chu-besancon.fr
Contact Person Name
Laura Mansi
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncologie
Principal Investigator Name
Julien Peron
Principal Investigator Email
julien.peron@chu-lyon.fr
Contact Person Name
Julien Peron
Contact Person Email
julien.peron@chu-lyon.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie
Principal Investigator Name
Alexandra Leary
Principal Investigator Email
alexandra.leary@gustaveroussy.fr
Contact Person Name
Alexandra Leary

Poland

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
157
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Uniwersyteckie Centrum Onkologii
Principal Investigator Name
Paweł Knapp
Principal Investigator Email
knapp@umb.edu.pl
Contact Person Name
Paweł Knapp
Contact Person Email
knapp@umb.edu.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Szpital Morski im.PCK Odd.Onkologii i Radioterapii Odd. Onkologii Klinicznej Leczenie „Jednego Dnia"
Principal Investigator Name
Joanna Pikiel
Principal Investigator Email
joanna.pikiel@post.pl
Contact Person Name
Joanna Pikiel
Contact Person Email
joanna.pikiel@post.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Principal Investigator Name
Radosław Mądry
Principal Investigator Email
radoslaw.madry@usk.poznan.pl
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@usk.poznan.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Ginekologicznej-Gynaecological Cancer Unit
Principal Investigator Name
Beata Maćkowiak Matejczyk
Principal Investigator Email
bmackowiak@onkologia.bialystok.pl
Contact Person Name
Beata Maćkowiak Matejczyk
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej
Principal Investigator Name
Dagmara Klasa Mazurkiewicz
Principal Investigator Email
dklasa@gumed.edu.pl
Contact Person Name
Dagmara Klasa Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii, Siedleckie Centrum Onkologii
Principal Investigator Name
Lubomir Bodnar
Principal Investigator Email
lbodnar@szpital.siedlce.pl
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl

Spain

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
186
Number Of Sites
12
Number Of Participants
35

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical oncology
Principal Investigator Name
Alfonso Cortés Salgado
Principal Investigator Email
acsalgado86@gmail.com
Contact Person Name
Alfonso Cortés Salgado
Contact Person Email
acsalgado86@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Medical oncology
Principal Investigator Name
Ignacio Romero Noguera
Principal Investigator Email
iromero@fivo.org
Contact Person Name
Ignacio Romero Noguera
Contact Person Email
iromero@fivo.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Medical oncology
Principal Investigator Name
María Quindos Varela
Principal Investigator Email
maria.quindos.varela@sergas.es
Contact Person Name
María Quindos Varela
Contact Person Email
maria.quindos.varela@sergas.es
Site Name
University Hospital Son Espases
Department Name
Medical oncology
Principal Investigator Name
Marina Justo de la Peña
Principal Investigator Email
marina.justo@ssib.es
Contact Person Name
Marina Justo de la Peña
Contact Person Email
marina.justo@ssib.es
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Medical oncology
Principal Investigator Name
Pau Guillén Sentís
Principal Investigator Email
pguillens@iconcologia.net
Contact Person Name
Pau Guillén Sentís
Contact Person Email
pguillens@iconcologia.net
Site Name
Hospital Universitario La Paz
Department Name
Medical oncology
Principal Investigator Name
Andrés Redondo Sánchez
Principal Investigator Email
aredondo12@gmail.com
Contact Person Name
Andrés Redondo Sánchez
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical oncology
Principal Investigator Name
Luis Manuel Manso Sánchez
Principal Investigator Email
luismansosanchez@gmail.com
Contact Person Name
Luis Manuel Manso Sánchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Medical oncology
Principal Investigator Name
Ana Puertes Boix
Principal Investigator Email
a.junio1986@gmail.com
Contact Person Name
Ana Puertes Boix
Contact Person Email
a.junio1986@gmail.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Medical oncology
Principal Investigator Name
María Pilar Barretina Ginesta
Principal Investigator Email
mpbarretina@iconcologia.net
Contact Person Name
María Pilar Barretina Ginesta
Contact Person Email
mpbarretina@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical oncology
Principal Investigator Name
David García Illescas
Principal Investigator Email
dgillescas@vhio.net
Contact Person Name
David García Illescas
Contact Person Email
dgillescas@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical oncology
Principal Investigator Name
María del Mar Gordon Santiago
Principal Investigator Email
gordonsantiago@gmail.com
Contact Person Name
María del Mar Gordon Santiago
Contact Person Email
gordonsantiago@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Medical oncology
Principal Investigator Name
Lydia Gaba García
Principal Investigator Email
lgaba@clinic.cat
Contact Person Name
Lydia Gaba García
Contact Person Email
lgaba@clinic.cat

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Name
IQVIA RDS Hellas Single Member S.A.
Name
Bioclinica Inc.
Responsibilities
Central imaging, ePRO
Name
Labcorp Central Laboratory Services SARL
Name
Medidata Solutions Inc.
Name
Azenta US Inc.
Responsibilities
Long-Term Sample Storage

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long-Term Sample Storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging, ePRO","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
DS-8201a
Active Substance
Trastuzumab deruxtecan
Modality
ADC
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
1
Starting Dose
5.4 mg/kg
Maximum Dose
91.8 mg/kg
Investigational Product Name
Docetaxel AqVida 20 mg/ml (comparator)
Active Substance
Docetaxel
Modality
Small molecule
Routes Of Administration
Intravenous injection
Route
Intravenous injection
Authorisation Status
2
Maximum Dose
75 mg/m2
Investigational Product Name
Cisplatin Hikma 1 mg/ml (comparator)
Active Substance
Cisplatin
Modality
Small molecule
Routes Of Administration
Intravenous injection
Route
Intravenous injection
Authorisation Status
2
Maximum Dose
50 mg/m2
Investigational Product Name
Paclitaxel Ribosepharm 6 mg/ml (comparator)
Active Substance
Paclitaxel
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
2
Maximum Dose
175 mg/m2
Investigational Product Name
Carboplatin Hikma 10 mg/ml (comparator)
Active Substance
Carboplatin
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
2
Maximum Dose
750 mg
Combination Treatment
Yes

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