A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy

Start 25 Jul 2023 · Status Ongoing, recruitment ended · 14 EU/EEA countries · 223 sites · Protocol D8531C00002

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 4,300

Countries 14

Sites 223

ER+/HER2- Early Breast Cancer

To demonstrate superiority of extended therapy with camizestrant over the standard endocrine therapy in preventing breast cancer recurrence

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: 25 Jul 2023 → ongoing
Decision date (initial): 2023-07-03
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: AstraZeneca AB, Sweden

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenomic, Efficacy, Safety, Pharmacokinetic, Therapy

To demonstrate superiority of extended therapy with camizestrant over the standard endocrine therapy in preventing breast cancer recurrence

Secondary objectives 4

To evaluate the efficacy of extended therapy with camizestrant compared to standard endocrine therapy in terms of overall survival and other measures
To evaluate the safety of extended therapy with camizestrant compared to with standard endocrine therapy
To characterize the camizestrant pharmacokinetics (PK)
To assess patient-reported treatment associated symptoms and quality of life between camizestrant and standard endocrine therapy

Conditions and MedDRA coding

ER+/HER2- Early Breast Cancer

Version	Level	Code	Term	System organ class
20.0	SOC	10029104	Neoplasms benign malignant and unspecified (incl cysts and polyps)	2

Regulatory references

Scientific advice from competent authorities: European Medicines Agency
Plan to share IPD: Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Women and Men; ≥18 years at the time of screening (or per national guidelines)
Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Adequate organ and marrow function

Exclusion criteria 11

Inoperable locally advanced or metastatic breast cancer
Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists or any of its excipients, that would preclude the patient from receiving any LHRH agonist
Pathological complete response following treatment with neoadjuvant therapy
History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
Known LVEF <50% with heart failure NYHA Grade ≥2.
Mean resting QTcF interval > 480 ms at screening congenital long QT syndrome, immediate family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
Concurrent exogenous sex hormone therapy
Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
Any evidence of severe or uncontrolled systemic diseases which, in the investigator’s opinion precludes participation in the study or compliance
Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Primary efficacy - IBCFS(invasive breast cancer free-survival) as defined by STEEP 2.0 criteria

Secondary endpoints 4

Secondary efficacy - IDFS (invasive disease-free survival) as defined by STEEP 2.0 criteria; DRFS (distant relapse-free survival) as defined by STEEP 2.0 criteria; OS (overall survival)
Secondary safety Safety endpoints include, but are not limited to the following: TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) Clinical laboratory tests, and vital signs
Secondary COAs (clinical outcome assessment) Patient-reported tolerability • Change from baseline of arthralgia, hot flush, and vaginal dryness • Proportion of patients experiencing each level of symptomatic AEs (adverse event) (arthralgia, hot flush, and vaginal dryness) as measured by the EORTC-IL-194 • Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC-QLQ-C30
Secondary PK(pharmacokinetic(s)) - Plasma concentrations of camizestrant pre-dose (Ctrough) (trough concentration)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Camizestrant

PRD9916833 · Product

Active substance: Camizestrant
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 00 mg milligram(s)
Max total dose: 00 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ASTRAZENECA AB
Paediatric formulation: No
Orphan designation: No

Comparator 4

Nolvadex® 20 mg Filmtabletten

PRD379324 · Product

Active substance: Tamoxifen Citrate
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: L02BA01 — TAMOXIFEN
Marketing authorisation: 5117.01.00
MA holder: ASTRAZENECA GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Packaging and relabeling for use in clinical trials

Exemestane

SUB07492MIG · Substance

Active substance: Exemestane
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relabelling for use in clinical trial

Arimidex® 1 mg Filmtabletten

PRD8589744 · Product

Active substance: Anastrozole
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1 mg milligram(s)
Max total dose: 1 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: L02BG03 — ANASTROZOLE
Marketing authorisation: 37180.00.00
MA holder: LABORATOIRES JUVISE PHARMACEUTICALS
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Packaging and relabeling for use in clinical trials

Letrozole

SUB08444MIG · Substance

Active substance: Letrozole
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 2.5 mg milligram(s)
Max total dose: 2.5 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Repackaging and relebeling for use in clinical trials

Auxiliary 5

Triptorelin

SUB11324MIG · Substance

Active substance: Triptorelin
Pharmaceutical form: PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR
Max daily dose: 0.13 mg milligram(s)
Max total dose: 3.75 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Leuprorelin

SUB08449MIG · Substance

Active substance: Leuprorelin
Pharmaceutical form: PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR
Max daily dose: 0.13 mg milligram(s)
Max total dose: 3.75 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Leuprorelin

SUB08449MIG · Substance

Active substance: Leuprorelin
Pharmaceutical form: PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR
Max daily dose: 0.13 mg milligram(s)
Max total dose: 11.25 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Goserelin

SUB07962MIG · Substance

Active substance: Goserelin
Pharmaceutical form: IMPLANT IN PRE-FILLED SYRINGE
Route of administration: SUBCUTANEOUS
Max daily dose: 0.13 mg milligram(s)
Max total dose: 10.8 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Goserelin

SUB07962MIG · Substance

Active substance: Goserelin
Pharmaceutical form: IMPLANT
Route of administration: SUBCUTANEOUS
Max daily dose: 0.13 mg milligram(s)
Max total dose: 3.6 mg milligram(s)
Max treatment duration: 60 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

Third parties 9

Organisation	City, country	Duties
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other
Thermo Fisher Scientific ORG-100021401	Bishop'S Stortford, United Kingdom	Laboratory analysis
LabCorp Clinical Development Limited ORL-000000948	Marousi, Greece	On site monitoring, Other
Fortrea Inc. ORG-100012602	Durham, United States	On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8
Signant Health Global LLC ORG-100040604	Blue Bell, United States	Other
Cytel Inc. ORG-100042560	Waltham, United States	Other
Labcorp Central Laboratory Services S.a.r.l. ORG-100012849	Meyrin, Switzerland	Laboratory analysis
Labcorp Early Development Laboratories Limited ORG-100011365	Harrogate, United Kingdom	Laboratory analysis
Medidata Solutions Inc. ORG-100016256	New York, United States	E-data capture

Locations

14 EU/EEA countries · 223 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruitment ended	133	14
Belgium	Ongoing, recruitment ended	64	10
Bulgaria	Ongoing, recruitment ended	22	10
Czechia	Ongoing, recruitment ended	13	4
France	Ongoing, recruitment ended	120	35
Germany	Ongoing, recruiting	236	28
Greece	Ongoing, recruitment ended	50	13
Hungary	Ongoing, recruitment ended	46	10
Italy	Ongoing, recruitment ended	134	17
Netherlands	Ongoing, recruitment ended	7	4
Poland	Ongoing, recruitment ended	98	11
Portugal	Ongoing, recruitment ended	94	10
Romania	Ongoing, recruitment ended	45	12
Spain	Ongoing, recruitment ended	521	45
Rest of world Georgia, Chile, Turkey, United States, Singapore, Serbia, Taiwan, Peru, Korea, Republic of, India, Mexico, United Kingdom, Malaysia, China, Israel, Vietnam, Philippines, Argentina, Thailand, Brazil, Japan, Australia, Canada, South Africa	—	2,717	—

Investigational sites

Austria

14 sites · Ongoing, recruitment ended

Medical University Of Graz

Klinische Abteilung fur Gynakologie, Neue Stiftingtalstrasse 6, 8010, Graz

Medical University Of Graz

Klin. Abt. f. Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz

Krankenanstalt Sanatorium Hera, Brustgesundheitszentrum

Chirurgie, Löblichgasse 14, 1090, Vienna

Ordensklinikum Linz GmbH

Internal I, Seilerstaette 4, 4020, Linz

Klinik Hietzing

Gyn. Abteilung, Wolkersbergenstrasse 1, Hietzing, Vienna

Klinikum Wels-Grieskirchen GmbH

Abt. f. Innere Medizin IV, Grieskirchner Strasse 42, 4600, Wels

Klinikum Klagenfurt am Wörthersee

Gynäkologie und Geburtshilfe, Feschnigstrasse 11, 9020, Klagenfurt am Wörthersee

Medical University Of Vienna

Chirurgie, Waehringer Guertel 18-20, Alsergrund, Vienna

Medical University Of Vienna

Allg. Gynäkologie u. gyn. Onkologie / Senologie, Waehringer Guertel 18-20, Alsergrund, Vienna

Oberoesterreichische Gesundheitsholding GmbH

Innere Med., Dr. Wilhelm Bock-Strasse 1, Duernau, Voecklabruck

Ordination Brustzentrum St. Veit

Ordination, Grabenstraße 10, 9300, St. Veit/Glan

Medizinische Universitaet Innsbruck

Klin. Abt. f. Gynäkologie u. Geburtshilfe, Anichstrasse 35, 6020, Innsbruck

Allgemein Oeffentliches Bezirkskrankenhaus Kufstein

Onkologie, Endach 27, Endach, Kufstein

Oberoesterreichische Gesundheitsholding GmbH

2. Med. Abteilung, Sierninger Strasse 170, 4400, Steyr

Belgium

10 sites · Ongoing, recruitment ended

Ziekenhuis Aan De Stroom

Oncology Department, Oosterveldlaan 24, 2610, Antwerp

UZ Leuven

Gynaecological Oncology Department, Herestraat 49, 3000, Leuven

Antwerp University Hospital

Oncology Department, Drie Eikenstraat 655, 2650, Edegem

Clinique Saint-Pierre

Oncology Department, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve

Centre Hospitalier Regional De La Citadelle

Medical Oncology Department, Bld Du Douzieme-De-Ligne 1, 4000, Liege

CHU UCL Namur

Oncology Department, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir

UZ Brussel

Medical Oncology Department, Laarbeeklaan 101, 1090, Jette

Universitair Ziekenhuis Gent

Medical Oncology Department, Corneel Heymanslaan 10, 9000, Gent

AZ Klina

Medical Oncology Department, Augustijnslei 100, 2930, Brasschaat

CHU Helora

Oncology and Hematology departments, Boulevard President Kennedy 2, 7000, Mons

Bulgaria

10 sites · Ongoing, recruitment ended

Complex Oncology Center Vratsa EOOD

Department of Medical Oncology, Bulevard Vtori Yuni 68, 3000, Vratsa

University Multiprofessional Hospital For Active Treatment Palmed Ltd.

Department of Medical Oncology, Ulitsa Perushtitsa 1a, 4002, Plovdiv

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

Clinic of Medical Oncology, Bulevard Peshtersko Shose 66, 4002, Plovdiv

Specialized Hospital for Active Treatment of Oncology Diseases Prof. d-r Marin Mushmov EOOD

Department of Medical Oncology, 22 Andrei Saharov Blvd, 1784, Sofia

Acibadem City Clinic Tokuda University Hospital EAD

Department of Medical Oncology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya

Military Medical Academy

Department of Medical Oncology, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya

Complex Oncological Center Plovdiv EOOD

Department of Medical Oncology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv

Mbal Za Zhensko Zdrave Nadezhda OOD

Clinic of Medical Oncology, Blaga Vest Street 3, 1330, Sofia

University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD

Department of Medical Oncology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia

Multiprofile Hospital For Active Treatment Dobrich AD

Department of Medical Oncology, Ulitsa Panayot Hitov 24, 9300, Dobrich

Czechia

4 sites · Ongoing, recruitment ended

MEDICON Services s.r.o.

Oncology, Antala Staska 1670/80, Krc, Prague 4

Multiscan s.r.o.

Oncology, Kyjevská 44, 532 03, Pardubice

Fakultni Nemocnice Bulovka

Oncology, Budinova 67/2, Liben, Prague

Onkologická ambulance Nemocnice Hořovice - Multiscan s.r.o.

Oncology, K Nemocnici 1106/14, 268 01, Hořovice

France

35 sites · Ongoing, recruitment ended

Centre De Lutte Contre Le Cancer Eugene Marquis

Medical Oncology Department, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex

Institut Bergonie

Medical Oncology Department, 229 Cours De L Argonne, 33000, Bordeaux

Centre Hospitalier Victor Dupouy

Medical Oncology Department, 69 Rue Du Lieutenant Colonel Prudhon, 95107, Argenteuil Cedex

Institut Curie

Medical Oncology Department, 35 Rue Dailly, 92210, Saint-Cloud

Centre Francois Baclesse

Medical Oncology Department, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5

Centre Hospitalier Universitaire De Poitiers

Medical Oncology Department, 2 Rue De La Miletrie, 86000, Poitiers

Centre Hospitalier De Cholet

Medical Oncology Department, 1 Rue De Marengo, 49300, Cholet

Centre Hospital Region Metz Thionville

Medical Oncology Department, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03

Hopital Prive Jean Mermoz

Medical Oncology Department, 55 Avenue Jean Mermoz, 69008, Lyon

Centre Hospitalier Universitaire De Nimes

Medical Oncology Department, Place Du Professeur Robert Debre, 30900, Nimes

Institut Gustave Roussy

Medical Oncology Department, 114 Rue Edouard Vaillant, 94800, Villejuif

L'Hopital Prive Du Confluent

Medical Oncology Department, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2

Institut De Cancerologie De L Ouest

Medical Oncology Department, Bd Du Professeur Jacques Monod, 44800, St Herblain

Institut Sainte Catherine

Medical Oncology Department, 250 Chemin De Baigne Pieds, 84000, Avignon

Centre Jean Perrin

Medical Oncology Department, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1

Centre Hospitalier Universitaire De Saint Etienne

Medical Oncology Department, Avenue Albert Raimond, 42270, Saint Priest En Jarez

Hopital Saint Louis

Medical Oncology Department, 1 Avenue Claude Vellefaux, 75010, Paris

Centre Hospitalier Lyon Sud

Medical Oncology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite

Centre Hospitalier Annecy Genevois

Medical Oncology Department, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex

Institut Universitaire Du Cancer Toulouse-Oncopole

Medical Oncology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9

Hopital Prive Des Cotes D'armor

Medical Oncology Department, 10 Rue Francois Jacob, 22190, Plerin

Hopital Universitaire Pitie Salpetriere

Medical Oncology Department, 47 Boulevard De L Hopital, 75651, Paris Cedex 13

Centre Hospitalier Intercommunal De Cornouaille

Medical Oncology Department, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex

Institut Regional Du Cancer De Montpellier

Medical Oncology Department, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5

Centre Leon Berard

Medical Oncology Department, 28 Rue Laennec, 69008, Lyon

Centre Hospitalier De Bourg-En-Bresse

Medical Oncology Department, 900 Route De Paris, 01000, Bourg En Bresse

Centre De Cancerologue Du Grand Montpellier

Medical Oncology Department, 25 Rue De Clementville, 34070, Montpellier

Oncoradio Centre Oncogard

Medical Oncology Department, Rue Du Professeur Henri Pujol Institut De Cancerologie, 30029, Nimes Cedex 9

Institut De Cancerologie De L Ouest

Medical Oncology Department, 15 Rue Andre Boquel, 49100, Angers

Groupe Hospitalier Bretagne Sud

Medical Oncology Department, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient

Polyclinique Bordeaux Nord Aquitaine

Medical Oncology Department, 33 Rue Docteur Finlay, 33300, Bordeaux

Centre Oscar Lambret

Medical Oncology Department, 3 Rue Frederic Combemale, 59000, Lille

Hospital Foch

Medical Oncology Department, 40 Rue Worth, 92150, Suresnes

Centre Hospitalier Regional Universitaire De Tours

Medical Oncology Department, 2 Boulevard Tonnelle, 37044, Tours Cedex 9

Institut Paoli-Calmettes

Medical Oncology Department, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille

Germany

28 sites · Ongoing, recruiting

Praxis Dr. med. J. Schilling

-, Wönnichstr. 64-66, 10317, Berlin

Klinikum Memmingen

Frauenklinik, Bismarckstraße 23, 87700, Memmingen

Franziskus Hospital Harderberg

-, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette

Gynäkologische Praxisklinik Hamburg-Harburg

-, Harburger Ring 10, 21073, Hamburg

Gemeinschaftspraxis Hamatologie Onkologie

-, Arnoldstraße 18, Johannstadt-Nord, Dresden

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Klinik für Gynäkologie und Geburtshilfe, Ludwig-Erhard-Strasse 90, Dotzheim, Wiesbaden

Haematologie-Onkologie im Zentrum MVZ GmbH

-, Halderstrasse 29, Innenstadt, Augsburg

Rotkreuzklinikum Munchen gGmbH

Frauenklinik, Taxisstrasse 3, Neuhausen-Nymphenburg, Munich

Klinikum Esslingen GmbH

Klinik für Frauenheilkunde, Brustzentrum, Hirschlandstraße 97, Oberesslingen, Esslingen Am Neckar

National Center For Tumor Diseases (NCT) Heidelberg

Department of Gynecologic Oncology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg

Dr. Vehling-Kaiser MVZ GmbH

-, Achdorfer Weg 5, Achdorf, Landshut

Onkodok GmbH

-, Brunnenstrasse 14, Innenstadt, Gutersloh

Studienzentrale fuer das MVZ Eggenfelden e.K.

Gynäkologische Onkologie, Wolfsberger Anger 68, Kirchberg, Eggenfelden

Klinikum Worms gGmbH

-, Gabriel-Von-Seidl-Strasse 81, Herrnsheim, Worms

Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie&Palliativmedizin

Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin, Hohe Weide 17 b, 20259, Hamburg

DBZ Onkologie GmbH

-, Hönower Straße 31-33, 12623, Berlin

Universitaetsklinikum Aachen AöR

Department for Gynecology and Obstetrics, Pauwelsstrasse 30, 52074, Aachen

GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbH

-, August-Bebel-Strasse 59, 65428, Ruesselsheim Am Main

Staedtisches Klinikum Dessau

Klinik für Frauenheilkunde und Geburtshilfe, Auenweg 38, Alten, Dessau-Roßlau

Kreiskrankenhaus Torgau Johann Kentmann gGmbH

Onkologie/Gynäkologie, Christianistrasse 1, 04860, Torgau

Helios Universitaetsklinikum Wuppertal

-, Heusnerstrasse 40, Barmen, Wuppertal

Klinikum Mutterhaus der Borromaeerinnen gGmbH

Onkologisches Zentrum, Feldstrasse 16, Innenstadt, Trier

Technische Universitat Dresden

Nationales Centrum für Tumorerkrankungen Dresden Gynäkologisches Krebszentrum und Regionales Brustze, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Gynaekologisches Zentrum Bonn

-, Friedensplatz 16, Zentrum, Bonn

MVZ fuer Haematologie und Onkologie Ravensburg GmbH

-, Elisabethenstrasse 19, 88212, Ravensburg

Gynäkologie Kompetenzzentrum Stralsund

-, Böttcherstraße 34, 18439, Stralsund

Universitaetsklinikum Duesseldorf AöR

Frauenklinik, Moorenstraße 5, Bilk, Düsseldorf

MVZ Medical Center Duesseldorf GmbH

GynOnco Düsseldorf Zentrum für Gynäkologische Onkologie, Luise-Rainer-Strasse 6-10, Flingern Nord, Duesseldorf

Greece

13 sites · Ongoing, recruitment ended

University General Hospital Attikon

Haematology-Oncology, Rimini Street 1, 124 62, Athens

University General Hospital Of Heraklion

Department of Medical Oncology, Stavrakia And Voutes, 715 00, Heraklion

Theageneio Cancer Hospital

3rd Department of Clinical Oncology, Papanastassiou Alexandrou 11, 546 39, Thessaloniki

University General Hospital Of Ioannina

Medical Oncology, Niarchou Stavrou Avenue, 455 00, Ioannina

General Hospital Of Thessaloniki Papageorgiou

Medical Oncology, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia

Diagnostic & Therapeutic Center of Athens HYGEIA Single Member S.A.

Breast Unit, Erithrou Stavrou 4, 151 24, Maroussi

Metaxa Cancer Center Hospital Of Piraeus

Medical Oncology, Botassi 51, 185 37, Pireas

Euromedica General Clinic Of Thessaloniki

Oncology Department, Kallas Marias 11, Gravias 2, Thessaloniki

Athens Medical Center S.A.

3rd Department of Oncology, Pylea, Asklipiou 10, Thessaloniki

St. Luke's Hospital S.A.

Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki

General University Hospital Of Patras

Medical Oncology, Rio, 265 04, Patras

Alexandra Hospital

Medical Oncology-Unit Therapeutic Clinic, Vassilissas Sofias Avenue 80, 115 28, Athens

Areteio Hospital

2nd Surgical Department Oncology Unit, Vassilissas Sofias Avenue 76, 115 28, Athens

Hungary

10 sites · Ongoing, recruitment ended

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

Onkoradiológia, Szent Istvan Utca 68, 4400, Nyiregyhaza

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Onkoradiológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor

Tolna Vármegyei Balassa János Kórház

Onkológiai Osztály, Béri Balogh Ádám u. 5-7, 7100, Szekszárd

Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz

Klinikai Onkológiai Osztály, Tetenyi Ut 12-16, XI Kerulet, Budapest

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Onkológiai Centrum, Tallian Gyula Utca 20-32, 7400, Kaposvar

University Of Debrecen

Onkológiai Klinika, Nagyerdei Korut 98, 4032, Debrecen

Bekes Varmegyei Koezponti Korhaz

Megyei Onkológiai Centrum, Semmelweis Utca 1, 5700, Gyula

Semmelweis Egyetem

Belgyógyászati és Onkológiai Központ, Baross Utca 23, 1082, Budapest

Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz

Klinikai Onkológiai és Sugárterápiás Centrum Sugárterápiás Osztály, Szentpeteri Kapu 72-76, 3526, Miskolc

Orszagos Onkologiai Intezet

Gyógyszeterápiás Központ, Mellkasi és hasüregi daganatok és Klinikai Farmakológiai Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII

Italy

17 sites · Ongoing, recruitment ended

Azienda Ospedaliero Universitaria Pisana

UO Oncologia Medica, Via Roma 67, 56126, Pisa

Azienda Ospedaliera Universitaria Mater Domini

UO Oncologia Medica Traslazionale, Viale Tommaso Campanella 115, 88100, Catanzaro

Careggi University Hospital

Radioterapia Oncologica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Medicina di Precisione Neoplasia della Mammella, Largo Francesco Vito 1, 00168, Rome

Ospedale San Raffaele S.r.l.

Oncologia Medica, Via Olgettina 60, 20132, Milan

Azienda Sanitaria Usl Toscana Sud Est

Oncologia Medica, Via Senese 169, 58100, Grosseto

Azienda Ospedaliera Universitaria Federico II Di Napoli

Oncologia Medica, Via Sergio Pansini 5, 80131, Naples

Azienda Ospedaliero Universitaria Di Modena

Oncologia ed Ematologia, Largo Del Pozzo 71, 41124, Modena

Azienda Ospedaliera Ordine Mauriziano Di Torino

Oncologia, Via Ferdinando Magellano 1, 10128, Turin

Azienda Ospedaliera Di Reggio Emilia Arcispedale S Maria Nuova Irccs

UOC Oncologia Provinciale, Viale Umberto Primo 50, 42123, Reggio Emilia

European Institute Of Oncology S.r.l.

Divisione di Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan

University Hospital Consorziale Policlinico

Oncologia Medica, Piazzale Giulio Cesare 11, 70124, Bari

IRCCS Istituto Nazionale Tumori - Fondazione Pascale

Oncologia Medica Senologica, Via Mariano Semmola 53, 80131, Naples

Humanitas Istituto Clinico Catanese S.p.A.

Oncologia Medica, Contrada Cubba Sp54 11, 95045, Misterbianco

Humanitas Research Hospital

Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano

Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli

Oncologia, Via Antonio Cardarelli 9, 80131, Naples

IRCCS Ospedale Policlinico San Martino

Clinica di Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa

Netherlands

4 sites · Ongoing, recruitment ended

Stichting Zuyderland Medisch Centrum

Internal Medicine/oncology, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen

Spaarne Gasthuis Stichting

Internal Medicine/Oncology, Spaarnepoort 1, 2134 TM, Hoofddorp

Het Van Weel-Bethesda Ziekenhuis

Internal Medicine/oncology, Stationsweg 22, 3247 BW, Dirksland

Ikazia Ziekenhuis

Medical oncology, Montessoriweg 1, 3083 AN, Rotterdam

Poland

11 sites · Ongoing, recruitment ended

Mruk-Med I Sp. z o.o.

Oncology Department, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow

Bialostockie Centrum Onkologii Im M Sklodowskiej-Curie W Bialymstoku

Department of Medical Oncology with Day Unit, Ul. Ogrodowa 12, 15-027, Bialystok

Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynała Wyszynskiego SPZOZ W Lublinie

Oncology Department, Aleja Krasnicka 100, 20-718, Lublin

Instytut Msf Sp. z o.o.

Oncology Department, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz

Mazowiecki Szpital Onkologiczny Sp. z o.o.

Outpatient Oncology Clinic Department, Ul. Koscielna 61, 05-135, Wieliszew

Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie

Department of Clinical Oncology with a Subdivision of One-day Chemotherapy, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin

Centrum Medyczne Hcp Sp. z o.o.

-, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan

Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Clinical Oncology Department, Ul. Dr. Ludwika Rydygiera 15/17, 86-300, Grudziadz

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

-, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu

Clinical Oncology Department with Day Unit, Ul. Katowicka 66a, 45-061, Opole

Szpital Rejonowy Im. Dr Jozefa Rostka W Raciborzu

Chemotherapy Departament, Ul. Gamowska 3, 47-400, Raciborz

Portugal

10 sites · Ongoing, recruitment ended

Unidade Local De Saude Do Alto Ave E.P.E.

Oncologia, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes

Sao Joao University Hospital Center

Medical Oncology, Alameda Professor Hernani Monteiro, 4200-319, Porto

Unidade Local De Saude De Gaia/Espinho E.P.E.

Medical Oncology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia

Unidade Local De Saude De Santa Maria E.P.E.

Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon

Unidade Local De Saude De Amadora Sintra E.P.E.

Oncology, Itinerario Complementar 19, 2720-276, Amadora

CCAB Centro Clinico Academico Braga Associacao

Oncology, Lugar De Sete Fontes S Victor, 4710-243, Braga

Unidade Local De Saude De Matosinhos E.P.E.

Oncology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora

Hospital CUF Porto S.A.

Oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto

Hospital Cuf Descobertas S.A.

Oncology, Rua Mario Botas 1, 1998-018, Lisbon

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.

Medical Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto

Romania

12 sites · Ongoing, recruitment ended

Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.

Oncology, Strada Crisului Nr. 1, 500283, Brasov

Ovidius Clinical Hospital S.R.L.

Oncology, Dn 2a Km 202 880, 905900, Ovidiu

Oncolab S.R.L.

Oncology, Strada Bujorului 7, 200385, Craiova

Centrul De Oncologie SF Nectarie S.R.L.

Oncology, Strada Caracal Nr. 109, 200542, Craiova

Radiotherapy Center Cluj S.R.L.

Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti

Spitalul Clinic Judetean De Urgenta Sibiu

Oncology, Bulevardul Coposu Corneliu 2-4, 550245, Sibiu

Centrul De Oncologie-Euroclinic S.R.L.

Oncology, Strada Conta Vasile 2, 700106, Jassi

Gral Medical S.R.L.

Oncology, Spitalul Oncofort, Aleea Doctor Ana Aslan Nr 15, Pitesti

Onco Clinic Consult S.A.

Oncology, Strada Sararilor 28j, 200508, Craiova

Oncomed S.R.L.

Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara

Medisprof S.R.L.

Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca

Institute Of Oncology Prof Dr Ion Chiricuta Cluj Napoca

Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca

Spain

45 sites · Ongoing, recruitment ended

Hospital Universitario Central De Asturias

-, Avenida De Roma S/n, 33011, Oviedo

Hospital Universitario Clinico San Cecilio

Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada

Hospital Universitario Marques De Valdecilla

-, 5 Planta, Avenida Valdecilla S/n, Santander

Hospital Universitario Hm Sanchinarro

-, Calle Ona 10, 28050, Madrid

MD Anderson Cancer Center

-, Calle De Arturo Soria Nº 270, 28033, Madrid

Hospital Arnau De Vilanova De Valencia

-, Calle De San Clemente 12, 46015, Valencia

Hospital General Universitario De Alicante

-, ª Centro De Diagnosticos, Avinguda Del Pintor Baeza 12, Alicante

Hospital Del Mar

Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona

Hospital Universitario De Badajoz

-, Avenida Elvas S/n, 06006, Badajoz

Hospital General Universitario De Albacete

Oncology, Calle Hermanos Falco 37, 02006, Albacete

Hospital General Universitario Morales Meseguer

-, Avenida Del Marques De Los Velez S/n, 30008, Murcia

University Hospital Virgen Del Rocio S.L.

Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Universitari Dexeus Grupo Quironsalud

-, Calle De Sabino Arana 5-19, 08028, Barcelona

Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida

-, Av. Alcalde Rovira Roure 80, 25198, Lleida

Hospital Obispo Polanco

-, Avenida De Ruiz Jarabo S/n, 44002, Teruel

Fundacion Instituto Valenciano De Oncologia

Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia

Hospital Universitario Virgen De La Macarena

-, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Hospital Universitario De La Ribera

Oncology Department, Carretera Corbera 1, 46600, Alzira

Hospital San Pedro de Alcantara

-, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres

Hospital De Galdakao Usansolo

-, Leku Barrio Labeaga 46 A, 48960, Galdakao

Hospital Clinic De Barcelona

-, Calle Villarroel 170, 08036, Barcelona

Centro Oncologico De Galicia

-, Rua Doctor Camilo Veiras 1, 15009, A Coruna

Hospital General Universitario De Elche

-, Edificio 2, Camino De La Almazara 11, Elche

Hospital Universitario De Toledo

Oncology, Avenue Del Rio Guadiana Sn, 45007, Toledo

Hospital Clinico San Carlos

-, Calle Del Profesor Martin Lagos S/n, 28040, Madrid

Catalan Institute Of Oncology

-, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Complexo Hospitalario Universitario A Coruna

-, Lugar Jubias De Arriba 84, 15006, A Coruna

Institut Catala D'oncologia

Oncology, Carretera Canyet S/n, 08916, Badalona

Hospital Universitario De Salamanca

-, Paseo De San Vicente 58-182, 37007, Salamanca

Institut Catala D'oncologia

Oncology, Avinguda De Franca S/n, 17007, Girona

Hospital De Jerez De La Frontera

-, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera

Hospital Universitario Donostia

-, Pasealeku Doct. Begiristain 109, 20014, Donostia

Hospital Universitario Fundacion Jimenez Diaz

-, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital De Sagunto

-, Calle De Ramon Y Cajal 46, 46520, Sagunto

Hospital Universitario Dr Peset Aleixandre

-, Avinguda De Gaspar Aguilar 90, 46017, Valencia

Hospital Universitari Vall D Hebron

-, Passeig De La Vall D Hebron 119-129, 08035, Barcelona

Hospital Universitario Infanta Cristina

Oncology, Avenida De 9 De Junio 2, 28981, Parla

Hospital Universitario Puerta De Hierro De Majadahonda

-, Calle De Manuel De Falla 1, 28222, Majadahonda

Salut Sant Joan De Reus Baix Camp

-, Avinguda Del Doctor Josep Laporte 2, 43204, Reus

Hospital Quironsalud Sagrado Corazon

-, Calle De Rafael Salgado 3, 41013, Sevilla

Hospital Virgen De Los Lirios

-, Calle Caramanxel S/n, 03804, Alcoy

Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada

Oncology, Dr Joan Soler 1-3, 08243, Manresa

Hospital Universitario De Cruces

-, Cruces Plaza S/n, 48903, Barakaldo

Hospital Universitario Virgen De Las Nieves

-, Avenida De Las Fuerzas Armadas 2, 18014, Granada

Hospital Universitario Severo Ochoa

-, Avenida Orellana S/n, 28911, Leganes

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start	Recruitment end
Austria	2023-08-18	2023-09-14	2025-04-16
Belgium	2023-08-08	2023-10-05	2026-02-26
Bulgaria	2023-08-28	2023-09-05	2025-04-16
Czechia	2023-10-10	2023-12-01	2025-04-16
France	2024-04-17	2024-05-14	2025-04-16
Germany	2023-09-04	2024-01-02
Greece	2023-09-21	2023-11-13	2025-04-16
Hungary	2023-09-29	2023-11-28	2025-04-16
Italy	2023-08-23	2023-09-25	2025-04-16
Netherlands	2023-07-31	2023-10-02	2025-04-16
Poland	2023-08-04	2024-03-07	2026-02-26
Portugal	2023-07-27	2023-09-19	2026-02-26
Romania	2023-07-28	2023-10-10	2025-04-16
Spain	2023-07-25	2023-08-29	2026-02-27

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 384 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_GR_Protocol_2022-501024-20_Greek_Redacted	6.0
Protocol (for publication)	D1_Protocol_2022-501024-20_Redacted	6.0
Recruitment arrangements (for publication)	D8531C00002_PRT_HSOG_Recruitment Modality_Redacted	NA
Recruitment arrangements (for publication)	K_D8531C00002_RO_Recruitment and Informed Consent Procedure_Romanian	N/A
Recruitment arrangements (for publication)	K1_D8531C00002 Recruitment and informed consent procedure_Poland_redacted	2.0
Recruitment arrangements (for publication)	K1_D8531C00002_AUT_Recruitment and Informed Consent Procedure Form	NA
Recruitment arrangements (for publication)	K1_D8531C00002_BG_Recruitment arrangements and ICF procedure_Bulgarian	2
Recruitment arrangements (for publication)	K1_D8531C00002_CZ_Recruitment and ICF procedure_FNB	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_CZ_Recruitment and ICF procedure_MEDICON	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_CZ_Recruitment and ICF procedure_Multiscan Pardubice	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_CZ_Recruitment and ICF procedure_ON Horovice	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_CZ_Recruitment and ICF procedure_ON Pribram_Redacted	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_DE_Recruitment and Informed Consent Procedure Form	NA
Recruitment arrangements (for publication)	K1_D8531C00002_FR_Recruitment and Informed Consent_redacted	NA
Recruitment arrangements (for publication)	K1_D8531C00002_GR_Recruitment and Informed consent procedure	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_HU_Recruitment and informed consent procedure	v2
Recruitment arrangements (for publication)	K1_D8531C00002_IT_Recruitment arrangements_English	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_ITA_Recruitment and Informed Consent Procedure Form	N/A
Recruitment arrangements (for publication)	K1_D8531C00002_PRT_Declaration Recruitment Arrangements	NA
Recruitment arrangements (for publication)	K1_D8531C00002_PRT_Recruitment and Informed Consent Procedure Form	NA
Recruitment arrangements (for publication)	K1_D8531C00002_PRT_Statement of subject documents submitted in EN_Redacted	NA
Recruitment arrangements (for publication)	K1_D8531C00002_Recruitment and ICF procedure	2.0
Recruitment arrangements (for publication)	K1_D8531C00002_Recruitment and Informed Consent Form_redacted	NA
Recruitment arrangements (for publication)	K1_Recruitment arrangements	4
Recruitment arrangements (for publication)	K1_Recruitmentarrangements_ICF-procedure 2	N/A
Recruitment arrangements (for publication)	K2_D851C00002_Recruitment material_Closure_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Advertisement Content_Polish	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_ Recruitment material_Leaflet for patients_Bulgarian_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Advertisement_Content_Bulgarian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Call_Agent_Content_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Closure_Content_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Consent Navigator Bulgarian_Redacted	2.1
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Dr-to-Pt-Letter_Bulgarian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Informed_Consent_Animation_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Landing Page Content_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Landing Page Privacy Content_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Self-Assessment_Content_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_BG_Recruitment material_Tri-Fold_Brochure_Bulgarian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Call Agent Content_Polish_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Closure Content_Polish_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Consent Navigator_Polish_redacted	2.1
Recruitment arrangements (for publication)	K2_D8531C00002_DE_Recruitment material_Digital pack Click and Lead Campaigns	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_DE_Recruitment material_Patient Communication_Probando	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_DE_Recruitment material_Patient Journey Registration Process Probando	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_DE_Recruitment material_Probando Homepage Text	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_DE_Recruitment material_Probando Privacy	5.0
Recruitment arrangements (for publication)	K2_D8531C00002_DE_Recruitment material_Probando_Social Media	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_Dr-to-Pt-Letter_Polish	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Advertisement content	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Call Agent content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Closure Content_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Doctor to Patient letter_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Informed Consent animation_Redacted_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Landing page content_Redacted_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Landing page privacy content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Longboat Consent Navigator_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Patient leaflet_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Self Assessment content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_FR_Tri fold brochure_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_HU_Consent Navigator_Redacted	2.1
Recruitment arrangements (for publication)	K2_D8531C00002_HU_Dr-to-Pt-Letter_	2
Recruitment arrangements (for publication)	K2_D8531C00002_HU_Leaflet for patients_Redacted	1
Recruitment arrangements (for publication)	K2_D8531C00002_HU_Tri-Fold_Brochure_Redacted	2
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Advertisement_Content_Italian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Call_Agent_Content_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Closure_Content_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Consent Navigator_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Dr-to-Pt-Letter_Italian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Informed_Consent_Animation_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Landing Page Content_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Landing Page Privacy Content_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Leaflet for patients_Italian_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Self-Assessment_Content_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_IT_Recruitment material_Tri-Fold_Brochure_Italian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Landing Page Privacy Content_Polish_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Leaflet for patients_Polish_redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_PL_Informed Consent Animation_Polish_redacted_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_PL_Landing Page Content_Polish_redacted_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Additional Country Information for CEIC	NA
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Consent Navigator_EN_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Consent Navigator_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Leaflet for patients_EN_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Leaflet for patients_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Tri-Fold_Brochure_EN_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_PRT_Tri-Fold_Brochure_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Advertisement_Content	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Advertisement_Content	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Advertisement_Content	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Call Agent Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Call_Agent_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Call_Agent_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Call_Agent_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Closure Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Closure_Content_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Closure_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Consent Navigator_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Consent Navigator_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Consent Navigator_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Consent Navigator_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Consent Navigator_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Dr to Patient Letter	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Dr-to-Pt-Letter	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Dr-to-Pt-Letter	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Dr-to-Pt-Letter	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Informed_Consent_Animation_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Informed_Consent_Animation_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Informed_Consent_Animation_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_LandingPageContent_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_LandingPageContent_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_LandingPageContent_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_LandingPagePrivacyContent_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_LandingPagePrivacyContent_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_LandingPagePrivacyContent_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Leaflet for patients_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Leaflet for patients_redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Leaflet for patients_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Leaflet for patients_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Leaflet for patients_Redacted	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Self-Assessment Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Self-Assessment_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Self-Assessment_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Self-Assessment_Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Tri-Fold Brochure no url_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Tri-Fold_Brochure_no_url_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Tri-Fold_Brochure_no_url_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Tri-Fold_Brochure_no_url_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment material_Tri-Fold_Brochure_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment materials_Advertisement Content	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment materials_Dr-to-Pt-Letter	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment materials_Informed Consent Animation_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment materials_Landing Page Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Recruitment materials_Landing Page Privacy Content_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment _Redacted_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Advertisement_Content_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Call_Agent_Content_Redacted_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Closure_Content_Redacted_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Consent Navigator_Romanian_Redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Dr-to-Pt-Letter_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Informed_Consent_Animation_Romanian_Redacted_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_LandingPage Content_Romanian_Redacted_	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_LandingPagePrivacyContent_Redacted_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Leaflet for patients_Redacted_Romanian	1.0
Recruitment arrangements (for publication)	K2_D8531C00002_RO_Recruitment material_Self-Assessment_Content__Redacted_Romanian	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Self-Assessment Content_Polish_redacted	2.0
Recruitment arrangements (for publication)	K2_D8531C00002_Tri-Fold_Brochure_Polish_redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material Advertisement content	2
Recruitment arrangements (for publication)	K2_Recruitment material Call agent content_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material Closure content_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material Consent Navigator_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material Dr to patient letter	2
Recruitment arrangements (for publication)	K2_Recruitment material Informed consent Animation_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material Landing page content_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material Landing page privacy content_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material leaflet for patients_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material Self assessment content_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material Tri fold brochure_Redacted	2
Recruitment arrangements (for publication)	K2_Recruitment material_Advertisement_Content Dutch-Belgium	2
Recruitment arrangements (for publication)	K2_Recruitment material_Advertisement_Content French-Belgium	2
Recruitment arrangements (for publication)	K2_Recruitment material_Advertisement_Content_English-Belgium	2
Recruitment arrangements (for publication)	K2_Recruitment material_Call_Agent_Content Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Call_Agent_Content_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Call_Agent_Content_French-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Closure_Content Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Closure_Content_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Closure_Content_French-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Consent Navigator Dutch-Belgium	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Consent Navigator English	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Consent Navigator French-Belgium	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Dr-to-Pt-Letter Dutch-Belgium	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Dr-to-Pt-Letter_English-Belgium	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Dr-to-Pt-Letter_French-Belgium	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Informed_Consent_Animation Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Informed_Consent_Animation French-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Informed_Consent_Animation_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPageContent Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPageContent French-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPageContent_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPagePrivacyContent Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPagePrivacyContent French-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPagePrivacyContent_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Leaflet for patients Dutch-Belgium_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Leaflet for patients English_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Leaflet for patients French-Belgium_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Self-Assessment_Content Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Self-Assessment_Content French-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Self-Assessment_Content_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Tri-Fold_Brochure_no_url_Dutch-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Tri-Fold_Brochure_no_url_English-Belgium_Redacted	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Tri-Fold_Brochure_no_url_French-Belgium_Redacted	2.0
Subject information and informed consent form (for publication)	D8531C00002 _RO_Other subject material econsent creation and submission_Redacted	1
Subject information and informed consent form (for publication)	E2_D8531C00002 _eConsent submission package_Bulgaria_Redacted	1
Subject information and informed consent form (for publication)	L1_D8531C00002_AUT_Contact details for German ICFs for Austria_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_AUT_Genetic ICF	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Main_eICF_Dutch_Print_Redacted	6
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Main_eICF_Dutch_Screenshots_Redacted	6
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Main_eICF_French_Print_Redacted	6
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Main_eICF_French_Screenshots_Redacted	6
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Future_Research_eICF_Dutch_Print	5
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Future_Research_eICF_Dutch_Screenshots	5
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Future_Research_eICF_French_Print	5
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Future_Research_eICF_French_Screenshots	5
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Genetic_eICF_Dutch_Print_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Genetic_eICF_Dutch_Screenshots_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Genetic_eICF_French_Print_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_BE_Optional_Genetic_eICF_French_Screenshots_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Main ICF_Bulgarian_Redacted	10.0
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Main ICF_English_Redacted	9.0
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Main_eICF_Bulgarian_Print_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Main_eICF_Bulgarian_Screenshots_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Optional Genetic ICF Bulgarian_Redacted	1
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Optional Genetic ICF_English_Redacted	1
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Optional_Genetic_eICF_Bulgarian_Print_Redacted	1
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_Optional_Genetic_eICF_Bulgarian_Screenshots_Redacted	1
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_PP ICF_Bulgarian_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_BG_PP ICF_English_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Future Research ICF_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Future Research_eICF_Print_Redacted	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Future Research_eICF_Screenshots_Redacted	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Genetic ICF_Redacted	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Genetic_eICF_Print_Redacted	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Genetic_eICF_Screenshots_Redacted	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Main ICF_Redacted	8.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Main_eICF_Print	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Main_eICF_Screenshots	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_CZ_Pregnant Partner ICF	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_DE_Future Research_eICF_Print	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_DE_Future Research_eICF_Screenshots	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_DE_Genetic_eICF_Print	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_DE_Genetic_eICF_Screenshots	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_DE_Main_eICF_Print_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_DE_Main_eICF_Screenshots_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ES_Annex to Main ICF_Redacted	8.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ES_Genetic ICF_Redacted	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ES_Main ICF_Redacted	9.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ES_Pregnant Partner ICF_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ES_RBR ICF_Redacted	6.0
Subject information and informed consent form (for publication)	L1_D8531C00002_FR_ICF Main_Portuguese_redacted	14.0
Subject information and informed consent form (for publication)	L1_D8531C00002_FR_Main ICF_French_Redacted	14.0
Subject information and informed consent form (for publication)	L1_D8531C00002_FR_PP ICF_French_Redacted	5.0
Subject information and informed consent form (for publication)	L1_D8531C00002_GR_Genetic ICF	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_GR_Main ICF_Redacted	9.0
Subject information and informed consent form (for publication)	L1_D8531C00002_GR_Pregnant Partner ICF_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_HU_Genetic ICF	v2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_HU_Genetic PIS	V2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_HU_Main ICF_redacted	9.0
Subject information and informed consent form (for publication)	L1_D8531C00002_HU_Memo_ICF Visual Aids	1
Subject information and informed consent form (for publication)	L1_D8531C00002_HU_Pregnant_ Partner ICF_redacted	4
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Main ICF_Italian_Redacted	12.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Main_eICF_Print_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Main_eICF_Screenshots_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Optional Future Research ICF_Italian_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Optional_Future_Research_eICF_Print	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Optional_Future_Research_eICF_Screenshots	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Optional_Genetic_eICF_Print	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Optional_Genetic_eICF_Screenshots	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Pregnancy ICF_Italian_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Privacy ICF_Italian_Redacted	7.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Privacy_eICF_Print	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_IT_Privacy_eICF_Screenshots	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ITA_Adult Subject ICF_Redacted	6.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ITA_Optional Future Research ICF	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ITA_Optional Genetic ICF	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ITA_Pregnancy ICF	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_ITA_Privacy ICF	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_NL_Main_eICF_Dutch_Print_Redacted	5
Subject information and informed consent form (for publication)	L1_D8531C00002_NL_Main_eICF_Dutch_Screenshots_Redacted	5
Subject information and informed consent form (for publication)	L1_D8531C00002_NL_Optional_Genetic_eICF_Dutch_Print_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_NL_Optional_Genetic_eICF_Dutch_Screenshots_Redacted	3
Subject information and informed consent form (for publication)	L1_D8531C00002_Other subject information material_e_Consent submission package_Redacted	NA
Subject information and informed consent form (for publication)	L1_D8531C00002_PL_Genetic Subject ICF_Polish_redacted	1
Subject information and informed consent form (for publication)	L1_D8531C00002_PL_Main ICF_Polish_Redacted	8.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PL_Main_eICF_Screenshots	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PL_Optional_Genetic_eICF_Screenshots	1.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PL_Pregnancy ICF_Polish_redacted	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Genetic ICF_Redacted	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Main ICF_English_Redacted	16.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Main ICF_Redacted	16.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Optional Genetic Research_Redacted	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Pregnant Participant ICF_Redacted	5.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Pregnant Participant_English_Redacted	5.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Pregnant Partner ICF_Redacted	5.0
Subject information and informed consent form (for publication)	L1_D8531C00002_PT_Pregnant Partner_English_Redacted	5.0
Subject information and informed consent form (for publication)	L1_D8531C00002_RO_Genetic ICF_Romanian	1
Subject information and informed consent form (for publication)	L1_D8531C00002_RO_Main ICF_Romanian_Redacted	9.0
Subject information and informed consent form (for publication)	L1_D8531C00002_RO_Pregnant Partner ICF_Romanian	2.0
Subject information and informed consent form (for publication)	L1_D8531C00002_RO_SIS and PP ICF_Romanian_Redacted	3.0
Subject information and informed consent form (for publication)	L1_D8531C00002_SIS and ICF_Contactdetails ICFs for Austria_Redacted	10.0
Subject information and informed consent form (for publication)	L1_D8531C00002_SIS and ICF_Future Research_Redacted	6.0
Subject information and informed consent form (for publication)	L1_D8531C00002_SIS and ICF_Main ICF_Redacted	11.0
Subject information and informed consent form (for publication)	L1_D8531C00002_SIS and ICF_Main_Redacted	13.0
Subject information and informed consent form (for publication)	L1_D8531C00002_SIS and ICF_Pregnant Partner ICF_Redacted	4.0
Subject information and informed consent form (for publication)	L1_D8531C00002_SIS and ICF_Pregnant Partner_Redacted	3.0
Subject information and informed consent form (for publication)	L1_RO_Main_eICF_Romanian_Print_Redacted	3
Subject information and informed consent form (for publication)	L1_RO_Main_eICF_Romanian_Screenshots_Redacted	3
Subject information and informed consent form (for publication)	L1_RO_Optional_Genetic_eICF_Romanian_Print	1
Subject information and informed consent form (for publication)	L1_RO_Optional_Genetic_eICF_Romanian_Screenshots	1
Subject information and informed consent form (for publication)	L1_SIS and ICF main ICF Dutch_Redacted	11.0
Subject information and informed consent form (for publication)	L1_SIS and ICF main ICF English_Redacted	9.0
Subject information and informed consent form (for publication)	L1_SIS and ICF optional genetic ICF Dutch_Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF optional genetic ICF English_Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF pregnant partner ICF Dutch_Redacted	4
Subject information and informed consent form (for publication)	L1_SIS and ICF pregnant partner ICF English_Redacted	4
Subject information and informed consent form (for publication)	L1_SIS and ICF_ADULT ICF_English_sponsor statement_Redacted	NA
Subject information and informed consent form (for publication)	L1_SIS and ICF_IVDR ICF_Dutch_CL_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_IVDR ICF_English_CL_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_IVDR ICF_French_CL_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_Dutch_Redacted	15.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_English_Redacted	15.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_French_Redacted	15.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main_BG_Redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional FUTURE RESEARCH ICF_Dutch_redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional FUTURE RESEARCH ICF_English_Redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional FUTURE RESEARCH ICF_French_redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional Genetic Research ICF_Dutch_Redacted	v3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional Genetic Research ICF_English_Redacted	v3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional Genetic Research ICF_French_Redacted	v3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Patient reimbursement ICF_Dutch_CL_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Patient reimbursement ICF_English_CL_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Patient reimbursement ICF_French_CL_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner ICF_Dutch_Redacted	V5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner ICF_English_Redacted	V5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner ICF_French_Redacted	V5.0
Subject information and informed consent form (for publication)	L2_D8531C00002_AUT_Mode of Action storyboard_Redacted	1
Subject information and informed consent form (for publication)	L2_D8531C00002_BG_MoA_storyboard_Bulgarian	NA
Subject information and informed consent form (for publication)	L2_D8531C00002_CZ_eConsent package_Redacted	1.0
Subject information and informed consent form (for publication)	L2_D8531C00002_CZ_Information Notice on Personal Data Protection for Czech Republic_Redacted	6.0
Subject information and informed consent form (for publication)	L2_D8531C00002_CZ_Knowledge check eConsent	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_CZ_MoA storyboard	1.0
Subject information and informed consent form (for publication)	L2_D8531C00002_DE_CEC request for review acc to StrSchG	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_DE_eConsent Creation and Submission_Part I_Redacted	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_DE_eConsent Creation and Submission_Part II	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_DE_eConsent Creation and Submission_Part III	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_DE_Mode of Action storyboard_Redacted	1
Subject information and informed consent form (for publication)	L2_D8531C00002_ES_Mode of Action Storyboard_Redacted	1.0
Subject information and informed consent form (for publication)	L2_D8531C00002_HU_Patient Alert Card_revised transparency rules	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_ITA_eConsent Submission Package_Redacted	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_ITA_MoA animation script subtitles and onscreen text	N/A
Subject information and informed consent form (for publication)	L2_D8531C00002_ITA_MoA Storyboard	1
Subject information and informed consent form (for publication)	L2_D8531C00002_PL_Mode of action storyboard_Polish	NA
Subject information and informed consent form (for publication)	L2_D8531C00002_PL_Submission package for eConsent_Redacted	NA
Subject information and informed consent form (for publication)	L2_D8531C00002_PT_A_1032_0084_5151QRG_SmartSignalseCOA	4.0
Subject information and informed consent form (for publication)	L2_D8531C00002_PT_A_1032_0084_5350DL	A
Subject information and informed consent form (for publication)	L2_D8531C00002_PT_A_1032_0084_DPS_Privacy notice	1.0
Subject information and informed consent form (for publication)	L2_D8531C00002_PT_A_1032_0084_Screen_Report_Smartphone_Redacted	6.0
Subject information and informed consent form (for publication)	L2_D8531C00002_PT_Recruitment and Informed Consent Procedure Form	NA
Subject information and informed consent form (for publication)	L2_D8531C00002_PT_SmartSignals eCOA Data Encryption_Redacted	NA
Subject information and informed consent form (for publication)	L2_D8531C00002_RO_MoA_storyboard_Romanian	NA
Subject information and informed consent form (for publication)	L2_D8531C00002_SIS and ICF_Optional Research_Redacted	3.0
Subject information and informed consent form (for publication)	L2_Mode of Action storyboard_Dutch	1
Subject information and informed consent form (for publication)	L2_Mode of Action storyboard_English	1
Subject information and informed consent form (for publication)	L2_Mode of Action storyboard_French	1
Subject information and informed consent form (for publication)	L2_Other subject information material econsent creation and submission_Redacted	2
Subject information and informed consent form (for publication)	L2_Other subject information material MOA storyboard	1
Subject information and informed consent form (for publication)	L2_Other subject information material_eConsent subm pack_Redacted	NA
Subject information and informed consent form (for publication)	L2_Other subject information material_SmartSignals eCOA Privacy Policy_redacted	2
Subject information and informed consent form (for publication)	L3_D8531C00002_CZ_Abort Reasons	N/A
Subject information and informed consent form (for publication)	L3_D8531C00002_CZ_GP letter_revised transparency rules placeholder	NA
Subject information and informed consent form (for publication)	L3_D8531C00002_CZ_Patient ID Card_revised transparency rules placeholder	NA
Subject information and informed consent form (for publication)	L3_D8531C00002_CZ_Thank You Card	1.0
Subject information and informed consent form (for publication)	L3_D8531C00002_FR_ICF Optional research_French_redacted	3.0
Subject information and informed consent form (for publication)	L3_D8531C00002_FR_ICF Optional research_Portuguese_redacted	3.0
Summary of Product Characteristics (SmPC) (for publication)	G2_D8531C00002_SmPC_exemestane_RSI	NA
Summary of Product Characteristics (SmPC) (for publication)	G2_D8531C00002_SmPC_letrozole_RSI	N/A
Summary of Product Characteristics (SmPC) (for publication)	G2_D8531C00002_SmPC_letrozole_RSI	NA
Summary of Product Characteristics (SmPC) (for publication)	G2_D8531C00002_SmPC_tamoxifen	N/A
Synopsis of the protocol (for publication)	D1_Lay Synopsis_AT_DE_German_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_BE_Dutch_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_BE_French_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_BE_German_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_BG_Bulgarian_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_CZ_Czech_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_EN_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_ES_Spanish_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay synopsis_FR_French_2022-501024-20	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_FR_French_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_GR_Greek_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_HU_Hungarian_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_IT_Italian_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_NL_Dutch_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_PL_Polish_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_PT_Portuguese_2022-501024-20_Redacted	5.0
Synopsis of the protocol (for publication)	D1_Lay Synopsis_RO_Romanian_2022-501024-20_Redacted	3.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_AT_DE_German_2022-501024-20	3.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_FR_French_2022-501024-20-00	5.0

Application history

28 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-03-06	Romania	Acceptable 2023-06-26	2023-06-27
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2023-06-29		Acceptable 2023-06-26	2023-06-29
3	NON SUBSTANTIAL MODIFICATION	NSM-3	2023-08-31	Romania	Acceptable 2023-06-26	2023-08-31
4	SUBSTANTIAL MODIFICATION	SM-1	2023-09-11	Romania	Acceptable 2023-12-18	2023-12-19
5	SUBSEQUENT ADDITION OF MSC	APP-5	2024-01-15		Acceptable 2023-12-18	2024-03-06
6	SUBSTANTIAL MODIFICATION	SM-2	2024-01-22		Acceptable	2024-04-17
7	SUBSTANTIAL MODIFICATION	SM-4	2024-01-23		Acceptable	2024-03-01
8	SUBSTANTIAL MODIFICATION	SM-5	2024-01-23		Acceptable	2024-03-11
9	SUBSTANTIAL MODIFICATION	SM-3	2024-01-25		Acceptable	2024-04-15
10	SUBSTANTIAL MODIFICATION	SM-7	2024-01-25		Acceptable	2024-03-25
11	SUBSTANTIAL MODIFICATION	SM-8	2024-01-25		Acceptable	2024-03-05
12	SUBSTANTIAL MODIFICATION	SM-9	2024-01-25		Acceptable	2024-02-28
13	SUBSTANTIAL MODIFICATION	SM-6	2024-01-26		Acceptable	2024-03-20
14	SUBSTANTIAL MODIFICATION	SM-10	2024-05-17	Romania	Acceptable 2024-08-26	2024-08-27
15	SUBSTANTIAL MODIFICATION	SM-14	2024-09-16		Acceptable	2024-10-10
16	SUBSTANTIAL MODIFICATION	SM-13	2024-09-20		Acceptable	2024-11-04
17	SUBSTANTIAL MODIFICATION	SM-12	2024-09-21		Acceptable	2024-10-16
18	SUBSTANTIAL MODIFICATION	SM-11	2024-09-24		Acceptable	2024-11-06
19	SUBSTANTIAL MODIFICATION	SM-15	2024-09-30		Acceptable	2024-10-23
20	SUBSTANTIAL MODIFICATION	SM-16	2025-01-27	Romania	Acceptable 2025-03-31	2025-04-01
21	SUBSTANTIAL MODIFICATION	SM-17	2025-05-12		Acceptable	2025-07-09
22	SUBSTANTIAL MODIFICATION	SM-18	2025-05-14		Acceptable	2025-07-28
23	SUBSTANTIAL MODIFICATION	SM-19	2025-05-21		Acceptable	2025-06-26
24	SUBSTANTIAL MODIFICATION	SM-20	2025-06-11		Acceptable	2025-07-21
25	SUBSTANTIAL MODIFICATION	SM-21	2025-08-29		Acceptable	2025-10-20
26	SUBSTANTIAL MODIFICATION	SM-22	2026-02-02	Romania	Acceptable 2026-05-11	2026-05-11
27	NON SUBSTANTIAL MODIFICATION	NSM-5	2026-05-19	Romania	Acceptable 2026-05-11	2026-05-19
28	NON SUBSTANTIAL MODIFICATION	NSM-6	2026-05-19	Romania	Acceptable 2026-05-11	2026-05-19

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy

Overview

Key facts

Trial design

Main objective

Secondary objectives 4

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 11

Endpoints

Primary endpoints 1

Secondary endpoints 4

Investigational products

Test 1

Comparator 4

Auxiliary 5

Sponsors and contacts

Astrazeneca AB

Scientific contact point

Public contact point

Third parties 9

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 384 files

Application history

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