Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,020
Countries
16
Sites
123
Advanced/Metastatic Breast Cancer
• To compare the efficacy of PF-07220060 in combination with letrozole (Arm A) versus CDK4/6i (investigator’s choice: abemaciclib, palbociclib, or ribociclib) in combination with letrozole (Arm B) with respect to progression-free survival (PFS)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 May 2025 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Pfizer Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety, Pharmacogenomic, Therapy
• To compare the efficacy of PF-07220060 in combination with letrozole (Arm A) versus CDK4/6i (investigator’s choice: abemaciclib, palbociclib, or ribociclib) in combination with letrozole (Arm B) with respect to progression-free survival (PFS)
Secondary objectives 1
- • To compare Arm A versus Arm B with respect to overall survival (OS)
Conditions and MedDRA coding
Advanced/Metastatic Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- • At least 18 years of age (or the minimum age of consent in accordance with local regulations) at screening.
- • Pre/perimenopausal female and male participants must receive therapy with an LHRH agonist (LHRHa) prior to the first dose of study intervention (if not already ongoing) and continue throughout the study as outlined in the SoA.
- • Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- • Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- • Documented HER2-negative tumor
- • Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease which is not amenable to curative treatment.
- • Participants must have either measurable disease or non-measurable bone-only disease per RECIST v1.1.
- • Participants must have an ECOG Performance Status of ≤2.
Exclusion criteria 5
- • In visceral crisis at risk of immediately life-threatening complications in the short term.
- • Current or past history of central nervous system metastases.
- • Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- • Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • PFS by blinded independent central review (BICR)
Secondary endpoints 1
- • OS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD12995006 · Product
- Active substance
- Atirmociclib Monohydrate
- Substance synonyms
- PF-07220060 monohydrate, (3S,4R)-4-((5-chloro-4-(4-fluoro-2-(2-hydroxypropan-2-yl)-1-isopropyl-1Hbenzo[d]imidazol-6-yl)pyrimidin-2-yl)amino)tetrahydro-2H-pyran-3-ol monohydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11029912 · Product
- Active substance
- PF-07220060 Monohydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB08444MIG · Substance
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
Comparator 7
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
SUB171907 · Substance
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
SUB180246 · Substance
- Active substance
- Ribociclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
PRD6503933 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/004
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
PRD6503994 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/006
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
PRD6503936 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging and labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Ppd Inc. ORG-100018960
|
Wilmington, United States | Other |
| Clario ORL-000006643
|
Philadelphia, United States | Other |
| TecEx ORL-000006567
|
Virginia Beach, United States | Other |
| Azenta Life Sciences ORL-000012135
|
Chelmsford, United States | Other |
| Premier Research ORL-000003568
|
Morrisville, United States | Other |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Other |
| Personalis Inc. ORG-100043141
|
Fremont, United States | Other |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Almac Clinical Services LLC ORG-100041692
|
Durham, United States | Other |
Locations
16 EU/EEA countries · 123 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 7 |
| Bulgaria | Ongoing, recruitment ended | 90 | 8 |
| Czechia | Ongoing, recruitment ended | 18 | 5 |
| Denmark | Ongoing, recruitment ended | 18 | 5 |
| Finland | Ongoing, recruitment ended | 13 | 5 |
| France | Ongoing, recruitment ended | 41 | 13 |
| Germany | Ongoing, recruitment ended | 19 | 8 |
| Greece | Ongoing, recruitment ended | 12 | 5 |
| Hungary | Ongoing, recruitment ended | 18 | 7 |
| Ireland | Ongoing, recruitment ended | 10 | 4 |
| Italy | Ongoing, recruitment ended | 26 | 11 |
| Netherlands | Ongoing, recruitment ended | 14 | 2 |
| Poland | Ongoing, recruitment ended | 22 | 11 |
| Slovakia | Ongoing, recruitment ended | 19 | 6 |
| Spain | Ongoing, recruitment ended | 64 | 21 |
| Sweden | Ongoing, recruitment ended | 22 | 5 |
| Rest of world
Korea, Republic of, United States, Mexico, Japan, United Kingdom, Switzerland, Israel, Canada, Turkey, Taiwan, Argentina, Chile, India, Australia, China, Brazil
|
— | 598 | — |
Investigational sites
Centre Hospitalier Universitaire De Liege
Medical Oncology, Avenue De L'hopital 1, 4000, Liege
Institut Jules Bordet
Clinical Trial Conduct Unit, Mijlenmeersstraat 90, 1070, Anderlecht
Grand Hopital De Charleroi
Oncology & Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Onze-Lieve-Vrouwziekenhuis
Oncology, Moorselbaan 164, 9300, Aalst
UZ Leuven
Gynaecologic Oncology, Herestraat 49, 3000, Leuven
Az Maria Middelares Gent
Oncology, Buitenring-Sint-Denijs 30, 9000, Gent
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
Complex Oncology Center - Burgas EOOD
First department of medical oncology, 73 Stefan Stambolov bul., 8000, Burgas
National Oncological Medical Center EOOD
Clinic of Medical Oncology, Ulitsa Plovdivsko Pole 6, 1756, Sofia
Mbal Za Zhensko Zdrave Nadezhda OOD
Clinic of Medical Oncology, Blaga Vest Street 3, 1330, Sofia
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Departement of Medical Oncology, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncological Center - Shumen EOOD
Departement of Medical Oncology, Ulitsa Vasil Aprilov 63, 9705, Shumen
Complex Oncological Center Plovdiv EOOD
Department of Medical Oncology and Oncology Diseases in Gastroenterology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
MBAL Serdika Ltd.
Departement of Medical Oncology, Bulevard Prezident Linkiln 128, 1632, Sofia
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
Departement of Medical Oncology, Ulitsa Doktor Iliev-Detskiya 1, 5300, Gabrovo
Fakultni Thomayerova nemocnice
Onkologická klinika 1. LF UK, Videnska 800, Krc, Prague 4
Fakultni Nemocnice Kralovske Vinohrady
Onkologická klinika, Srobarova 1150/50, Vinohrady, Prague
Nemocnice AGEL Novy Jicin a.s.
Oddělení radioterapie a onkologie, Purkynova 2138/16, 741 01, Novy Jicin
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice Brno
Interní hemataologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Esbjerg Og Grindsted Sygehus
N/A, Finsensgade 35, 6700, Esbjerg
Sygehus Soenderjylland Soenderborg
N/A, Sydvang 1, 6400, Soenderborg
Aarhus University Hospital
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
N/A, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
N/A, Blegdamsvej 9, 2100, Copenhagen Oe
Turku University Hospital
Oncology, Kiinamyllynkatu 4-8, 20520, Turku
Tampere University Hospital
N/A, Elamanaukio 2, 33520, Tampere
Vaasa Central Hospital
Department of Clinical Oncology, Hietalahdenkatu 2-4, 65130, Vaasa
Satakunnan Keskussairaala
N/A, Sairaalantie 3, 28500, Pori
HUS-yhtymae
N/A, Haartmaninkatu 4, 00290, Helsinki
Centr Georges Francois Leclerc
Medical oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier De La Cote Basque
Medical oncology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre De Cancerologue Du Grand Montpellier
Medical oncology, 25 Rue De Clementville, 34070, Montpellier
Institut De Cancerologie De L Ouest
Medical oncology, 15 Rue Andre Boquel, 49100, Angers
Centre Eugène Marquis
Medical oncology, Avenue de la Bataille de Flandres Dunkerque, 35000, Rennes
Hospices Civils De Lyon
Medical oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Departemental Vendee
Onco-hematology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
CHU Henri Mondor
Medical oncology, 51 avenue du marechal de Lattre de Tassigny, 94000, creteil
Institut Gustave Roussy
Medical oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Oscar Lambret
Medical oncology, 3 Rue Frederic Combemale, 59000, Lille
Centre Henri Becquerel
Medical oncology, 1 Rue D Amiens, 76000, Rouen
Institut Bergonié
Medical oncology, 229 cours de l'Argonne, 33076, Bordeaux
Universitaetsklinikum Erlangen AöR
NA, Maximiliansplatz 2, Innenstadt, Erlangen
Technische Universitaet Dresden
NA, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Leipzig AöR
NA, Liebigstrasse 20, Zentrum-Suedost, Leipzig
MVZ-Onkologie Velbert GbR
NA, Friedrichstrasse 311, Mitte, Velbert
Gemeinschaftspraxis Haematologie Onkologie
NA, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Studienzentrum Onkologie Ravensburg GmbH
NA, Elisabethenstrasse 19, 88212, Ravensburg
Facharztzentrum Eppendorf
NA, Eppendorfer Landstrasse 42, 20249, Hamburg
Institut Fuer Versorgungsforschung In Der Onkologie GbR
NA, Neversstrasse 5, Sued, Koblenz
Areteio Hospital
2nd Surgical Clinic – Oncology Unit, Vassilissas Sofias Avenue 76, 115 28, Athens
Saint Savvas Oncology Hospital
2nd Medical Oncology Department, Alexandras Avenue 171, 115 22, Athens
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
4th Pathology - Oncology Clinic, Erithrou Stavrou 4, 151 24, Maroussi
General Hospital Of Thessaloniki Papageorgiou
2nd Pathology - Oncology Clinic, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Of Heraklion
Department of Medical Oncology, Stavrakia And Voutes, 715 00, Heraklion
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Onkologiai Osztaly, Knezich Karoly Utca 1, 3300, Eger
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkologiai es Sugarterapias Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Onkoradiologia, Szent Istvan Utca 68, 4400, Nyiregyhaza
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Onkoradiologiai Osztaly, Vasvari Pal Utca 2-4, 9024, Gyor
Bekes Varmegyei Koezponti Korhaz
Megyei Onkologiai Centrum, Semmelweis Utca 1, 5700, Gyula
Orszagos Onkologiai Intezet
B-Belgyogyaszati Onkologiai Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Budapesti Uzsoki Utcai Korhaz
Onkoradiologiai Osztaly, Uzsoki Utca 29-41, 1145, Budapest XIV
Beaumont Hospital
NA, Beaumont Road, Beaumont, Dublin 9
St James's Hospital
Cancer clinical trials office, James's Street, D08 NHY1, Dublin 8
St Vincent's University Hospital
NA, Elm Park Merrion Road, D04 T6F4, Dublin 4
Mater Misericordiae University Hospital
Clinical Trials Research Unit, Eccles Street, D07 R2WY, Dublin 7
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
SSD Oncologia Medica- Zamagni (study is conducted at Via Giuseppe Massarenti 9, Bologna 40138), Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia Medica (study is conducted at Largo Agostino Gemelli 8, Roma 00168), Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Federico II Di Napoli
UOC Oncologia Medica, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Careggi
SOD Radioterapia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Centro Di Riferimento Oncologico Di Aviano
Oncologia Clinica, Via Franco Gallini 2, 33081, Aviano
IRCCS- Regina Elena National Cancer Institute
Oncologia Medica 1, 53 Via Elio Chianesi, 00144, Roma
Ospedale Isola Tiberina Gemelli Isola
UOC Oncologia Medica, Via Di Ponte Quattro Capi 39, 00186, Rome
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
Istituto Oncologico Veneto
UOC Oncologia 2, Via Gattamelata 64, 35128, Padova
Istituto Europeo Di Oncologia S.r.l.
Divisione Senologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Amphia Hospital
N/A, Molengracht 21, 4818 CK, Breda
Meander Medisch Centrum
Department of Medical Oncology, Maatweg 3, 3813 TZ, Amersfoort
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
N/A, Ul. Dr. Ludwika Rydygiera 15/17, 86-300, Grudziadz
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii Klinicznej, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddzial Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Instytut Msf Sp. z o.o.
N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Oddział onkologii klinicznej im. dr Ewy Pileckiej, Ul. Ogrodowa 12, 15-027, Bialystok
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
N/A, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Wsd Medi Clinical Sp. z o.o.
N/A, Aleja Jana Rodowicza Anody 22, 02-786, Warsaw
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Pratia S.A.
N/A, Ul. Pana Tadeusza 2, 30-727, Cracow
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Oddzial Onkologii Klinicznej, Ul. Borowa 14/18, 05-400, Otwock
Jagiellońskie Centrum Innowacji Sp. z o.o.
N/A, Ul. Prof. Michala Bobrzynskiego 14, 30-348, Cracow
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Oddelenie klinickej onkológie, Spitalska 2, 071 01, Michalovce
Nemocnica AGEL Komarno s.r.o.
Ambulancia klinickej onkológie, Medercska 39, 945 01, Komarno
Fakultna Nemocnica S Poliklinikou Nove Zamky
Oddelenie klinickej onkológie, Slovenska 11a, 940 02, Nove Zamky
Onkologicky Ustav Sv Alzbety s.r.o.
onkologická klinika, Heydukova 10, Stare Mesto, Bratislava
Narodny Onkologicky Ustav
Prsníkové centrum, Klenova 1, Nove Mesto, Bratislava
Fakultna Nemocnica Trnava
Onkologická klinika, Andreja Zarnova 11, 917 02, Trnava
Hospital Universitario da A Coruna
N/A, Av/AS Xubias 84, 15006, A Coruna
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Fundacion Instituto Valenciano De Oncologia
N/A, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital De Jerez De La Frontera
N/A, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Clinico San Carlos
Servicio de Oncologia Medica, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario Basurto
N/A, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario Hm Sanchinarro
N/A, Calle Ona 10, 28050, Madrid
Hospital Universitario Virgen De La Macarena
N/A, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario De Salamanca
N/A, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital General Universitario Gregorio Maranon
Servicio Oncologia Medica, Calle Del Doctor Esquerdo 46, 28007, Madrid
Complexo Hospitalario Universitario De Santiago
Servicio de Oncologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Arnau De Vilanova De Valencia
Servicio de Medicina Interna, Calle De San Clemente 12, 46015, Valencia
Hospital General Universitario De Elche
N/A, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Clinico San Cecilio
N/A, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario Virgen De La Victoria
Oncología Médica, Calle Del Arroyo Teatinos Sn, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
N/A, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Beata Maria Ana
N/A, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
University Clinical Hospital Virgen De La Arrixaca
N/A, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Region Joenkoepings Laen
Onkologkliniken, Lanssjukhuset Ryhov, Sjukhusgatan, Jonkoping
Uppsala University Hospital
NA, Akademiska Sjukhuset, 751 85, Uppsala
Soedersjukhuset AB
Onkologiska kliniken, Sjukhusbacken 10, Hogalid, Stockholm
Capio S:t Goerans Sjukhus AB
Klinisk forskningsenhet onkologi-kirurgi, Sankt Goransplan 1, Vastermalm, Stockholm
Västmanlands sjukhus Västerås
Onkologikliniken, Västmanlands sjukhus Västerås, 721 89, Västerås
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 |
|---|---|---|---|---|---|
| Belgium | 2025-05-26 | 2025-06-23 | 2025-11-24 | ||
| Bulgaria | 2025-05-07 | 2025-05-08 | 2025-11-24 | ||
| Czechia | 2025-05-14 | 2025-05-26 | 2025-11-24 | ||
| Denmark | 2025-05-09 | 2025-06-05 | 2025-11-24 | ||
| Finland | 2025-05-16 | 2025-05-27 | 2025-11-24 | ||
| France | 2025-06-11 | 2025-06-11 | 2025-11-24 | ||
| Germany | 2025-05-21 | 2025-07-16 | 2025-12-03 | ||
| Greece | 2025-05-21 | 2025-06-03 | 2025-11-24 | ||
| Hungary | 2025-05-30 | 2025-09-05 | 2025-11-24 | ||
| Ireland | 2025-06-10 | 2025-08-26 | 2025-11-24 | ||
| Italy | 2025-05-20 | 2025-05-30 | 2025-11-24 | ||
| Netherlands | 2025-07-01 | 2025-10-06 | 2025-11-24 | ||
| Poland | 2025-05-13 | 2025-06-06 | 2025-11-24 | ||
| Slovakia | 2025-05-12 | 2025-07-14 | 2025-11-24 | ||
| Spain | 2025-05-15 | 2025-05-21 | 2025-11-24 | ||
| Sweden | 2025-05-20 | 2025-06-11 | 2025-11-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 14 · Art. 38 CTR
Temporary halt TH-92637
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Spain
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92649
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Netherlands
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92639
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- France
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92629
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Belgium
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92652
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Slovakia
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92641
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Germany
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92631
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Bulgaria
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92643
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Greece
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92633
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Czechia
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92645
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Hungary
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92646
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Ireland
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92635
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Denmark
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92647
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Italy
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92650
- Halt date
- 2025-07-16
- Planned restart
- 2025-08-01
- Member states concerned
- Poland
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Due to comparator sourcing issues for the standard of care control arm and a resulting delay in resupply to participating sites, a temporary pause on new screening/recruitment will be implemented. This pause is not related to safety or quality issues. Drug supply is available for all participants on active study treatment and those who have started the screening process and have been entered for drug allocation; subject continuity will be maintained for these participants.
- Follow-up measures
- Drug supply will be replenished at the local drug distribution centre (depot) by end of July 2025.
- 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 177 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512925-95-00_C4391024_EL_public | PA3 |
| Protocol (for publication) | D1_Protocol_2024-512925-95-00_C4391024_public | PA3 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF Procedure_C4891024_SE_SV | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent Procedure_C4391024_BE_EN_Public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent procedure_C4391024_DK_EN_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent Procedure_C4391024_GR_EN_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4391024_CZ_CS_Public | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4391024_DE_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4391024_ES_EN_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4391024_FI_FI_Public | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4391024_IT_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C4391024_PL_PL_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material_Statement_C4391024_HU_EN_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements_C4391024_NL_EN_Public | 2 |
| Recruitment arrangements (for publication) | K10_Recruitment Material_Patient Webpage_Landing Page_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K11_Recruitment Material_Patient Webpage_Additional Imagery_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K12_Recruitment Material_Patient Webpage_Privacy_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K13_Recruitment Material_Patient Webpage_Steps to Join_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K14-1_Recruitment Material_Patient Webpage_Study Page_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K14-2_Recruitment Material_Patient Webpage_Study Page_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K15_Recruitment Material_Study Brochure_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K16_Recruitment Material_Study Poster_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K17_Recruitment Material_Patient Video QR Code_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K1a_Recruitment and informed consent Procedure_C4391024_FR_FR_public | 2 |
| Recruitment arrangements (for publication) | K1a_Recruitment and informed consent Procedure_C4391024_IE_EN_public | 2 |
| Recruitment arrangements (for publication) | K1a_Recruitment and informed consent Procedure_C4391024_SK_EN_public | 2 |
| Recruitment arrangements (for publication) | K1a_Recruitment Arrangements_C4391024_BG_BG_Public | 2 |
| Recruitment arrangements (for publication) | K1b_Recruitment and informed consent Procedure_C4391024_FR_FR_TC | 2 |
| Recruitment arrangements (for publication) | K1b_Recruitment Arrangements_C4391024_BG_BG_TC | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Breast Cancer Portfolio Brochure_C4391024_CZ_CS_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Breast Cancer Portfolio Brochure_C4391024_ES_ES_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Breast Cancer Portfolio Brochure_C4391024_IT_IT_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Breast Cancer Portfolio Brochure_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials_Patient Brochure_C4391024_FR FR_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials_Patient Brochure_C4391024_GR_EL_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials_Patient Brochure_SK_SK_public | 1a |
| Recruitment arrangements (for publication) | K2_Unbranded Retention Items_C4391024_IE_EN_public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_ Study Brochure_ C4391024_SK_SK_public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Patient Video QR Code_C4391024_GR_EL_public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_Patient Video_OST_ORT_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_Study Brochure_C4391024_CZ_CS_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_Study Brochure_C4391024_ES_ES_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Study Brochure_C4391024_FR_FR_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_Study Brochure_C4391024_IT_IT_Public | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Study Visit Guide_C4391024_IE EN_public | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment Material_Patient Video_VO_ORT_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment material_Study Brochure_C4391024_GR EL_public | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment material_Unbranded Retention Items Submission Form_C4391024_SK_EN_public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment material_ Study poster_ C4391024_GR EL_public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment Material_Patient Webpage_Clinical Trials_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K6_Recruitment Material_Patient Webpage_General FAQs_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K7-1_Recruitment Material_Patient Webpage_Homepage Tiles Layout_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K7-2_Recruitment Material_Patient Webpage_Homepage Tiles_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K8_Recruitment Material_Patient Webpage_Homepage Artwork_C4391024_PL_PL_Public | 1 |
| Recruitment arrangements (for publication) | K9_Recruitment Material_Patient Webpage_Homepage_C4391024_PL_PL_Public | 1 |
| Subject information and informed consent form (for publication) | L1_1a_ICD Main_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_2_ICD Optional Procedure_Baseline Biopsy_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_3_ICD Optional Procedure_EOT Biopsy_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_4_PPRIF_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_5a_ICD Genetic Research PIS_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_5b_ICD_Genetic Research CF_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_6_ICD_Retained Research Sample_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L1_Main ICD_C4391024_DK_DA_Public | 4 |
| Subject information and informed consent form (for publication) | L1_Main ICF_C4391024_CZ_CS_Public | 2 |
| Subject information and informed consent form (for publication) | L1_Main ICF_C4391024_ES_ES_Public | 4 |
| Subject information and informed consent form (for publication) | L1_Main ICF_C4391024_FI_FI_Public | 6 |
| Subject information and informed consent form (for publication) | L1_Main ICF_C4391024_IT_IT_Public | 2 |
| Subject information and informed consent form (for publication) | L1_Main ICF_C4391024_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1-1_Main ICF_C4391024_NL_NL_Public | 4 |
| Subject information and informed consent form (for publication) | L10_OPTIONAL ICD EOT Biopsy_C4391024_BE_EN_Public | 1 |
| Subject information and informed consent form (for publication) | L11_OPTIONAL ICD EOT Biopsy_C4391024_BE_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L12_OPTIONAL ICD EOT Biopsy_C4391024_BE_NL_Public | 1 |
| Subject information and informed consent form (for publication) | L13a_Scout ICD_C4391024_BE_EN_Public | 2 |
| Subject information and informed consent form (for publication) | L14a_Scout ICD_C4391024_BE_FR_Public | 2 |
| Subject information and informed consent form (for publication) | L15a_Scout ICD_C4391024_BE_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L1a_1_ICD Main_C4391024_BG_EN_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_ICD Main_C4391024_SE_SV_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C4391024_BE_EN_Public | 3 |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C4391024_DE_DE_Public | n/a |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C4391024_FR_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C4391024_GR_EL_public | 3 |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C4391024_IE_EN_Public | 4 |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C4391024_SK_SK_Public | 3 |
| Subject information and informed consent form (for publication) | L1b_1_ICD Main_C4391024_BG_BG_Public | N/A |
| Subject information and informed consent form (for publication) | L1b_Main ICD_C4391024_FR_FR_TC | 3 |
| Subject information and informed consent form (for publication) | L2_Biobank_Retained Research Samples ICF_C4391024_CZ_CS_Public | 2 |
| Subject information and informed consent form (for publication) | L2_Biobank_Retained Research Samples ICF_C4391024_ES_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Biobank_Retained Research Samples ICF_C4391024_FI_FI_Public | 2 |
| Subject information and informed consent form (for publication) | L2_Biobank_Retained Research Samples ICF_C4391024_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICD Biobank Retained Research Samples_C4391024_SE_SV_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Optional Biopsy ICF_Screening_C4391024_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Optional Biopsy_Screening_C4391024_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Optional Procedure ICD_Baseline Biopsy_C4391024_GR_EL_public | 1 |
| Subject information and informed consent form (for publication) | L2_PPRIF_C4391024_IE_EN_public | 1 |
| Subject information and informed consent form (for publication) | L2_SIC_C4391024_HU_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2-1_Optional Biopsy ICF_Baseline_C4391024_NL_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L2a_ICD Optional Biopsy_Baseline_C4391024_BG_EN_Public | N/A |
| Subject information and informed consent form (for publication) | L2a_ICD Retain Research Samples_C4391024_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L2a_Main ICD_C4391024_BE_FR_Public | 3 |
| Subject information and informed consent form (for publication) | L2a_PPRIF_C4391024_FR_FR_public | 2 |
| Subject information and informed consent form (for publication) | L2a_PPRIF_C4391024_SK_SK_Public | NA |
| Subject information and informed consent form (for publication) | L2b_ICD Optional Biopsy_Baseline_C4391024_BG_BG_Public | N/A |
| Subject information and informed consent form (for publication) | L3_ICD Optional Biopsy Screening_C4391024_SE_SV_Public | 1 |
| Subject information and informed consent form (for publication) | L3_Optional Biopsy ICF_Baseline_C4391024_CZ_CS_Public | 2 |
| Subject information and informed consent form (for publication) | L3_Optional Biopsy ICF_Baseline_C4391024_FI_FI_Public | 2 |
| Subject information and informed consent form (for publication) | L3_Optional Biopsy ICF_EoT_C4391024_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L3_Optional Biopsy_Baseline_C4391024_ES_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L3_Optional Biopsy_EoT_C4391024_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L3_Optional Biopsy_Sceening_C4391024_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3_OPTIONAL ICD Baseline Biopsy_C4391024_IE_EN_public | 1 |
| Subject information and informed consent form (for publication) | L3_Optional Procedure ICD EOT Biopsy_C4391024_FR_FR_public | 1 |
| Subject information and informed consent form (for publication) | L3_Optional Procedure ICD_EOT Biopsy_C4391024_GR_EL_public | 1 |
| Subject information and informed consent form (for publication) | L3_Privacy Supplement_C4391024_SK_SK_Public | 1 |
| Subject information and informed consent form (for publication) | L3-1_Optional Biopsy ICF_EoT_C4391024_NL_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L3a_ICD Optional Biopsy Baseline_C4391024_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L3a_ICD Optional Biopsy_EoT_C4391024_BG_EN_Public | N/A |
| Subject information and informed consent form (for publication) | L3a_List of ICDs and recruitment materials_C4391024_HU_HU_Public | NA |
| Subject information and informed consent form (for publication) | L3a_Main ICD_C4391024_BE_NL_Public | 3 |
| Subject information and informed consent form (for publication) | L3b_ICD Optional Biopsy_EoT_C4391024_BG_BG_Public | N/A |
| Subject information and informed consent form (for publication) | L4_Addendum to ICD_Right to not to know_C4391024_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L4_ICD Optional Biopsy EoT_C4391024_SE_SV_Public | 1 |
| Subject information and informed consent form (for publication) | L4_Optional Biopsy ICF_EoT_C4391024_CZ_CS_Public | 2 |
| Subject information and informed consent form (for publication) | L4_Optional Biopsy ICF_EoT_C4391024_FI_FI_Public | 2 |
| Subject information and informed consent form (for publication) | L4_Optional Biopsy_EoT_C4391024_ES_ES_Public | 1 |
| Subject information and informed consent form (for publication) | L4_Optional Biopsy_EoT_C4391024_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L4_OPTIONAL ICD EOT Biopsy_C4391024_IE_EN_public | 1 |
| Subject information and informed consent form (for publication) | L4_Optional Procedure ICD Baseline Biopsy_C4391024_FR_FR_public | 1 |
| Subject information and informed consent form (for publication) | L4_Optional Procedure ICD Baseline Biopsy_C4391024_SK_SK_public | 1 |
| Subject information and informed consent form (for publication) | L4_PPRIF_C4391024_BE_EN_Public | 1 |
| Subject information and informed consent form (for publication) | L4_Pregnant Partner ICF_C4391024_IT_IT_Public | 2 |
| Subject information and informed consent form (for publication) | L4-1_Pregnant Partner ICF_C4391024_NL_NL_Public | 2 |
| Subject information and informed consent form (for publication) | L4a_1_PPRIF_C4391024_BG_EN_Public | N/A |
| Subject information and informed consent form (for publication) | L4a_Optional Biopsy EoT_C4391024_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L4a_Pregnant Partner Release of Information Form_C4391024_GR_EL_public | 2 |
| Subject information and informed consent form (for publication) | L4b_1_PPRIF_C4391024_BG_BG_Public | N/A |
| Subject information and informed consent form (for publication) | L5_Adult Privacy Supplement ICF_C4391024_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L5_Appointment Card_C4391024_IE_EN_public | 1 |
| Subject information and informed consent form (for publication) | L5_EU Privacy Supplement Notice_C4391024_CZ_CS_Public | 1 |
| Subject information and informed consent form (for publication) | L5_Leaflet Rights of the subjects_C4391024_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L5_Optional Procedure ICD EOT Biopsy_C4391024_SK_SK_public | 1 |
| Subject information and informed consent form (for publication) | L5_PPRIF_C4391024_BE_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L5_Pregnant Partner ICF_C4391024_ES_ES_Public | 1.2 |
| Subject information and informed consent form (for publication) | L5_Pregnant Partner ICF_C4391024_FI_FI_Public | 2 |
| Subject information and informed consent form (for publication) | L5_Pregnant Partner ICF_C4391024_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L5_Study_Information_Card_C4391024_FR_FR_public | 1 |
| Subject information and informed consent form (for publication) | L5a_ICD Optional RRS_C4391024_BG_EN_Public | N/A |
| Subject information and informed consent form (for publication) | L5a_ICD Pregnant Partner Release_C4391024_SE_SV_Public | NA |
| Subject information and informed consent form (for publication) | L5a_ICD Pregnant Partner_C4391024_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L5b_ICD Optional RRS_C4391024_BG_BG_Public | N/A |
| Subject information and informed consent form (for publication) | L6_Optional Procedure ICD RRS_C4391024_SK_SK_public | 1 |
| Subject information and informed consent form (for publication) | L6_PPRIF_C4391024_BE_NL_Public | 1 |
| Subject information and informed consent form (for publication) | L6_PPRIF_C4391024_CZ_CS_Public | 2 |
| Subject information and informed consent form (for publication) | L6_SCOUT ICF_C4391024_PL_PL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L6a_ICD Optional Procedure Retained Research Samples_C4391024_IE_EN_public | 2 |
| Subject information and informed consent form (for publication) | L7_OPTIONAL ICD Baseline Biopsy_C4391024_BE_EN_Public | 1 |
| Subject information and informed consent form (for publication) | L7_Scout Adult ICD_C4391024_SK_SK | NA |
| Subject information and informed consent form (for publication) | L7_SCOUT ICD_C4391024_CZ_CS_Public | 1.0 |
| Subject information and informed consent form (for publication) | L8_OPTIONAL ICD Baseline Biopsy_C4391024_BE_FR_Public | 1 |
| Subject information and informed consent form (for publication) | L8_Study Information Card_C4391024_CZ_CS_Public | 1.1 |
| Subject information and informed consent form (for publication) | L9_OPTIONAL ICD Baseline Biopsy_C4391024_BE_NL_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_Abemaciclib_Verzenios_2024-512925-95-00_C4391024_EN | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_Letrozole_comparative table | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_Letrozole_Femara_2024-512925-95-00_C4391024_EN | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_Ribociclib_Kisqali_2024-512925-95-00_C4391024_comparative table | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC_Ribociclib_Kisqali_2024-512925-95-00_C4391024_EN | N/A |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_BE_2024-512925-95-00_C4391024_DE_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_BE_FR_2024-512925-95-00_C4391024_FR_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_BE_NL_2024-512925-95-00_C4391024_NL_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_BG_2024-512925-95-00_C4391024_BG_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_CZ_2024-512925-95-00_C4391024_CZ_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_ES_2024-512925-95-00_C4391024_ES_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_GR_2024-512925-95-00_C4391024_EL_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_HU_2024-512925-95-00_C4391024_HU_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_IT_2024-512925-95-00_C4391024_IT_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_PL_2024-512925-95-00_C4391024_PL_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_SE_2024-512925-95-00_C4391024_SV_public | PA3 |
| Synopsis of the protocol (for publication) | D2_Protocol-Synopsis_SK_2024-512925-95-00_C4391024_SK_public | PA3 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-28 | Sweden | Acceptable 2025-04-07
|
2025-04-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-09 | Acceptable 2025-04-07
|
2025-04-09 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-10 | Acceptable 2025-04-07
|
2025-04-10 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-11 | Acceptable 2025-04-07
|
2025-04-11 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-14 | Acceptable 2025-04-07
|
2025-04-14 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-15 | Acceptable | 2025-05-08 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-15 | Acceptable | 2025-05-05 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-30 | Sweden | Acceptable 2025-07-22
|
2025-07-22 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-06 | Sweden | Acceptable 2026-06-02
|
2026-06-02 |