Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,900
Countries
9
Sites
84
Triple Negative or Hormone Receptor low/HER2-negative Breast Cancer
To demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/H…
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Apr 2024 → ongoing
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2023-505928-59-00
- ClinicalTrials.gov
- NCT06112379
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy, Pharmacokinetic
To demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by investigator assessment of EFS.
Secondary objectives 3
- Key Secondary:To demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by central assessment of pCR.
- Key Secondary: To demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by assessment of OS.
- To assess effectiveness of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer, by assessment of DDFS.
Conditions and MedDRA coding
Triple Negative or Hormone Receptor low/HER2-negative Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participant must be ≥ 18 years, at the time of signing the ICF. - Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer - ECOG PS of 0 or 1 - Provision of acceptable tumour sample - Adequate bone marrow reserve and organ function - Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; and in alignment with protocol requirements.
Exclusion criteria 1
- History of any prior invasive breast malignancy - History of another primary malignancy except for non-breast malignancy treated with curative intent with no known active disease within 5 years before randomisation - Evidence of distant disease. - Clinically significant corneal disease. - Has active or uncontrolled hepatitis B or C virus. - Known HIV infection that is not well controlled. - Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals - Known to have active tuberculosis infection - Mean resting corrected QTcF interval > 470 ms obtained from ECG - Uncontrolled or significant cardiac disease. - History of non-infectious ILD/pneumonitis - Has severe pulmonary function compromise - Any prior or concurrent surgery, radiotherapy or any systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer - For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant. - Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer. - Concurrent use of systemic hormone replacement therapy or oral hormonal contraception
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Endpoint Event free survival (EFS) is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: disease progression precluding surgery, disease recurrence (local, regional, distant, or contralateral), second primary invasive cancer (other than squamous or basal cell skin cancer), or relapse from prior malignancy, or death by any cause (in the absence of recurrence).
Secondary endpoints 3
- Key Secondary: pathological complete response (pCR) rate is defined as the proportion of participants who have no evidence by haematoxylin and eosin staining of residual invasive disease or lymphovascular invasion at the time of definitive surgery in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by blinded central evaluation following completion of neoadjuvant systemic therapy per AJCC staging criteria (edition 8).
- Key secondary- overall survival (OS) is defined as the time from the date of randomisation until the date of death due to any cause.
- Distant disease-free survival (DDFS) is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: distant metastasis, occurrence of second primary invasive cancer (other than squamous or basal cell skin cancer), relapse from prior malignancy or death by any cause (in the absence of recurrence).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD9684738 · Product
- Active substance
- Datopotamab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- DAIICHI SANKYO, INC.
- Paediatric formulation
- No
- Orphan designation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC28 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 13
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06571MIG · Substance
- Active substance
- Epirubicin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lynparza 150 mg film-coated tablets
PRD6152224 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lynparza 150 mg film-coated tablet is identical to the IMP except that it has commercial deboss/marking. The IMP (used in this study) is unmarked and packed in HDPE bottles rather than the commercial blister pack to facilitate blinding in placebo controlled studies.
Lynparza 100 mg film-coated tablets
PRD6163466 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Lynparza 100 mg Tablet is identical to the IMP except that that it has a yellow film coat due to the deletion of a small amount of iron oxide, and has a commercial deboss/marking. The IMP has a green film coat, is unmarked and is supplied in an HDPE bottle rather than the commercial blister pack to facilitate blinding in placebo controlled studies.
SUB06391MIG · Substance
- Active substance
- Doxorubicin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
9 EU/EEA countries · 84 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 40 | 4 |
| Belgium | Ongoing, recruitment ended | 50 | 6 |
| Bulgaria | Ongoing, recruitment ended | 11 | 2 |
| France | Ongoing, recruitment ended | 70 | 13 |
| Germany | Ongoing, recruitment ended | 127 | 23 |
| Hungary | Ongoing, recruitment ended | 24 | 6 |
| Italy | Ongoing, recruitment ended | 72 | 12 |
| Poland | Ongoing, recruitment ended | 41 | 9 |
| Spain | Ongoing, recruitment ended | 66 | 9 |
| Rest of world
United Kingdom, Turkey, Thailand, Vietnam, China, India, Korea, Republic of, Taiwan, Canada, Australia, Singapore, United States, Malaysia, Hong Kong, Switzerland, Brazil, Japan
|
— | 1,399 | — |
Investigational sites
Medizinische Universitaet Innsbruck
University Clinic for Gynaecology and Obstetrics, Anichstrasse 35, 6020, Innsbruck
SCRI CCCIT Ges.m.b.H.
Abteilung für Innere Medizin III, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Medical Oncology and Hematology, Seilerstaette 4, 4010, Linz
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Internal Medicine II at LKH Rankweil, Carinagasse 47, 6800, Feldkirch
Universitair Ziekenhuis Gent
Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Hopital De Libramont
Oncology, Avenue De Houffalize 35, 6800, Libramont-Chevigny
UZ Leuven
Medical Oncology, Herestraat 49, 3000, Leuven
Ziekenhuis Aan De Stroom
Medical Oncology, Oosterveldlaan 24, 2610, Antwerp
Algemeen Ziekenhuis Klina
Oncology Hematology, Augustijnslei 100, 2930, Brasschaat
Grand Hopital De Charleroi
Oncology & Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
University Specialized Hospital For Active Treatment In Oncology EAD
Clinic of medical oncology, Ulitsa Plovdivsko Pole 6, 1756, Sofiya
Mbal Za Zhensko Zdrave Nadezhda OOD
Clinic of medical oncology, Blaga Vest Street 3, 1330, Sofia
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Polyclinique De Limoges
Medical Oncology, 18 Rue Du General Catroux, 87039, Limoges Cedex I
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli-Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Jean Perrin
Medical Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Hospitalier De La Cote Basque
Oncology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Sainte Catherine
Medical Oncology, 250 Chemin De Baigne Pieds, 84000, Avignon
Hopital Saint Louis
Medical Oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Institut De Cancerologie De Lorraine
Medical Oncology, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Centre Antoine Lacassagne
Medical Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Francois Baclesse
Medical Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Godinot
Medical Oncology, 1 Rue Du General Koenig, 51100, Reims
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Gynaekologisches Krebszentrum, Wilhelm-Epstein-Strasse 4, Bockenheim, Frankfurt Am Main
Medizinische Hochschule Hannover
Gynaekologische Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Haematologie-Onkologie im Zentrum MVZ GmbH
na, Halderstrasse 29, Innenstadt, Augsburg
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Gynaekologie, Martinistrasse 52, Eppendorf, Hamburg
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik fuer Frauenheilkunde Brustzentrum, Henricistrasse 92, Huttrop, Essen
HELIOS Klinikum Berlin-Buch GmbH
Geburtshilfe und Gynaekologie, Schwanebecker Chaussee 50, Buch, Berlin
Ulm University
Klinik fuer Frauenheilkunde und Geburtshilfe, Prittwitzstrasse 43, Mitte, Ulm
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medical Center - University Of Freiburg
Klinik fuer Frauenheilkunde, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitat Heidelberg
Gynaekologische Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Muenster AöR
"Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe Brustzentrum", Albert-Schweitzer-Campus 1, Sentrup, Muenster
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
na, Wirthstrasse 11c, Landwasser, Freiburg Im Breisgau
Diakovere Krankenhaus gGmbH
Frauenklinik, Schwemannstrasse 17-19, Kirchrode, Hanover
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik und Poliklinik fuer Geburtshilfe und Frauengesundheit, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Erlangen AöR
Frauenklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Gynaekologie und Geburtshilfe, Feldstrasse 16, Innenstadt, Trier
Vivantes MVZ GmbH
"Klinik fuer Innere Medizin Haematologie und Onkologie", Dieffenbachstrasse 1, Kreuzberg, Berlin
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik fuer Frauenheilkunde, Ismaninger Strasse 22, Au-Haidhausen, Munich
Klinikum Esslingen GmbH
Klinik fuer Frauenheilkunde und Geburtshilfe, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Staedtisches Klinikum Dessau
Klinik fuer Frauenheilkunde und Geburtshilfe, Auenweg 38, Alten, Dessau-Rosslau
Universitaetsklinikum Schleswig-Holstein
"Klinik fuer Gynaekologie und Geburtshilfe Frauenheilkunde", Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Heidelberg AöR
Nationales Centrum für Tumorerkrankungen, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Rotkreuzklinikum Muenchen gGmbH
Gynaekologie, Taxisstrasse 3, Neuhausen-Nymphenburg, Munich
Tolna Varmegyei Balassa Janos Korhaz
Onkológiai Osztály, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkológiai és Sugárterápiás Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Onkoradiológiai Osztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
Szent Lazar Megyei Korhaz
Onkológiai Centrum, Fuleki Ut 54-56, 3100, Salgotarjan
Orszagos Onkologiai Intezet
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály "Kemoterápia B", Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Istituto Oncologico Veneto
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Via Gattamelata 64, 35128, Padova
Ospedale Generale Provinciale Di Macerata
Dipartimento di Specialità Mediche-UOC Oncologia, Via Santa Lucia 2, 62100, Macerata
Azienda Sanitaria Universitaria Friuli Centrale
Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Divisione di Oncologia, Corso Spezia 60, 10126, Turin
Pia Fondazione Di Culto E Religione Card G Panico
Oncologia, Via Pio X 4, 73039, Tricase
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Divisione di Oncologia, Via Filippo Francesconi 556, 55100, Lucca
Azienda USL Toscana Centro
Divisione di Oncologia, Viale Giovanni Boccaccio 16, 50053, Empoli
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Divisione di Oncologia, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scienze della Salute della donna, del bambino e di sanità pubblica, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Humanitas Research Hospital
Unità Operativa di Oncologia ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Di Modena
Oncologia ed Ematologia, Largo Del Pozzo 71, 41124, Modena
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Oddzial Onkologii Klinicznej Im. Dr Ewy Pileckiej z Pododzialem Chemioterapii Dziennej, Ul. Ogrodowa 12, 15-027, Bialystok
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii I Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii I Radioterapii, Onkologia Kliniczna, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Onkologii oraz Poradnia Onkologiczna, Ul. Mikolaja Kopernika 50, 31-501, Cracow
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Oddzial Onkologii Klinicznej, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Breast Unit, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-04-15 | 2024-04-17 | 2025-07-16 | ||
| Belgium | 2024-04-15 | 2024-04-23 | 2025-07-03 | ||
| Bulgaria | 2024-04-19 | 2024-05-09 | 2025-06-20 | ||
| France | 2024-04-15 | 2024-04-23 | 2025-07-11 | ||
| Germany | 2024-04-15 | 2024-04-17 | 2025-06-27 | ||
| Hungary | 2024-05-17 | 2024-05-23 | 2025-06-12 | ||
| Italy | 2024-04-24 | 2024-04-29 | 2025-06-26 | ||
| Poland | 2024-04-15 | 2024-04-18 | 2025-05-06 | ||
| Spain | 2024-04-15 | 2024-04-16 | 2025-07-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 7 · Art. 38 CTR
Temporary halt TH-41050
- Halt date
- 2024-06-20
- Member states concerned
- France
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41060
- Halt date
- 2024-06-17
- Member states concerned
- Spain
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41053
- Halt date
- 2024-06-12
- Member states concerned
- Germany
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41055
- Halt date
- 2024-06-20
- Member states concerned
- Italy
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41057
- Halt date
- 2024-06-24
- Member states concerned
- Poland
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41046
- Halt date
- 2024-07-18
- Member states concerned
- Bulgaria
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-41048
- Halt date
- 2024-06-11
- Member states concerned
- Hungary
- Publication date
- 2024-08-14
- Reason
- Medicinal Product related
- Explanation
- Due to enrolment that has greatly exceeded the initial recruitment projections for this study, the Sponsor is facing limitations in the supply of investigational products (IP) supplied centrally, namely Dato-DXd, durvalumab and some standard of care chemotherapy agents. To manage the supply limitations the Sponsor is aiming to control the recruitment rate by putting limiting the number of new patients that can be screened per site/country each month. This requires that recruitment is temporarily stopped when the country limit is reached and restarted in a later month (see also separate letter attached).
- Follow-up measures
- See separate letter attached
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 100 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_redacted | 4.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Austria | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Germany | N/A |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_PL | 2 |
| Recruitment arrangements (for publication) | K1_Pamphlet_Dutch_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Pamphlet_French_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Patient Study Guide_Dutch_redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Patient Study Guide_French_redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Material_Poster_Dutch | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Material_Poster_French | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment material Pamphlet_HU_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Patient Pamphlet_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient PSG Guide_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Pamphlet_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Patient Guide_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Poster | 1 |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Poster_FR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pamphlet PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Recruitment Pamphlet_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Recruitment Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Guide PL_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Guide_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Guide_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Pamphlet_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult PL_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_Dutch_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_English_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_French_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF optional genetic PL | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_Dutch_clean | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_English_clean | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_French_clean | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL | 1 |
| Subject information and informed consent form (for publication) | L1_List of the submitted HU ICFs | N/A |
| Subject information and informed consent form (for publication) | L1_Optional Genetic Research Information and ICF | 1 |
| Subject information and informed consent form (for publication) | L1_Optional Genetic Research Information and ICF_Master | 1 |
| Subject information and informed consent form (for publication) | L1_Pregnant partner ICF | 1 |
| Subject information and informed consent form (for publication) | L1_Pregnant partner ICF_Master | 1 |
| Subject information and informed consent form (for publication) | L1_Research Study Consent Summary | 1 |
| Subject information and informed consent form (for publication) | L1_Research Study Consent Summary_Master | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Data privacy_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Subjects_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults Austria_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Bio Sample Research Addendum Information and Consent Form | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Genetic Research | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research Austria_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research Germany_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Austria | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Germany_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main with optional genetic research_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_HU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional future_HU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional genetic_HU | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_HU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF summary_HU | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult subject ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future research ICF_Redacted | 4.1 ES |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partners ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Study Consent Summary | 1 |
| Subject information and informed consent form (for publication) | L1_Site-specific data of the planned clinical trial sites_Austria_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Study information and informed consent form_Master_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Study information and informed consent form_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Poster | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Recruitment Pamphlet_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Guide_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient card HU | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Summary of Products Characteristics Carboplatin RSI | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Summary of Products Characteristics Doxorubicin RSI | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Summary of Products Characteristics Epirubicin RSI | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Summary of Products Characteristics Pembrolizumab RSI | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Summary of Products Characteristics Capecitabine RSI | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Summary of Products Characteristics Cyclophosphamide RSI | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_Summary of Products Characteristics Paclitaxel RSI | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis HU_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_Dutch 2023 505928 59_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_French 2023 505928 59_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_German 2023 505928 59_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_Lay language_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-505928-59-00_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_Lay language_2023-505928-59-00_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_lay language_PL_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_lay language_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_lay person_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LL_HU_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D2_Protocol Lay language synopsis Bulgaria 2023-505928-59-00_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D2_Protocol Scientific synopsis Bulgaria 2023-505928-59-00_Redacted | 3.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-17 | Spain | Acceptable 2024-03-12
|
2024-03-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-13 | Spain | Acceptable 2025-02-12
|
2025-02-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-25 | Acceptable | 2025-04-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-30 | Spain | Acceptable 2025-07-14
|
2025-07-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-07 | Spain | Acceptable 2026-02-06
|
2026-02-09 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-10 | Acceptable 2026-02-06
|
2026-03-10 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-23 | Acceptable 2026-02-06
|
2026-04-23 |