Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
204
Countries
5
Sites
27
Breast Cancer
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
- 14 Jan 2025 → ongoing
- Decision date (initial)
- 2024-11-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
5 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 12 | 3 |
| France | Ended | 12 | 4 |
| Poland | Ongoing, recruiting | 8 | 2 |
| Portugal | Ongoing, recruiting | 10 | 2 |
| Spain | Ongoing, recruiting | 56 | 16 |
| Rest of world
Korea, Republic of, Brazil, Argentina, Canada, United States, Mexico, Chile, Israel
|
— | 106 | — |
Investigational sites
Centre Hospitalier Regional De La Citadelle
Medical Oncology Department, Boulevard Du Douzieme De Ligne 1, 4000, Liege
UZ Leuven
Gynaecological Oncology Department, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Oncology Department, Drie Eikenstraat 655, 2650, Edegem
Hospital Foch
Medical Oncology Department, 40 Rue Worth, 92150, Suresnes
Centre Francois Baclesse
Medical Oncology Department, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Polyclinique Bordeaux Nord Aquitaine
Medical Oncology Department, 33 Rue Docteur Finlay, 33300, Bordeaux
Centre Hospitalier Universitaire De Poitiers
Medical Oncology Department, 2 Rue De La Miletrie, 86000, Poitiers
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Oddział Dzienny Chemioterapii, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Instytut Msf Sp. z o.o.
NA, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
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
Hospital Universitario De Salamanca
Ophthalmology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
Ophthalmology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Del Mar
Medical Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Beata Maria Ana
Medical Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
MD Anderson Cancer Center
Medical Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Consorci Sanitari Integral
Medical Oncology, Avinguda De Josep Molins 29-41, 08906, L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Severo Ochoa
Medical Oncology, Avenida Orellana S/n, 28911, Leganes
Institut Catala D'oncologia
Ophthalmology, Avinguda De Franca S/n, 17007, Girona
Hospital Universitari Dexeus Grupo Quironsalud
Ophthalmology, Gran Via De Carles III 71-75, 08028, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-01-14 | 2025-03-04 | |||
| Poland | 2025-11-25 | 2025-11-25 | |||
| Portugal | 2025-07-29 | 2025-08-07 | |||
| Spain | 2025-04-24 | 2025-05-07 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Spain | Acceptable 2024-11-04
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-13 | Spain | Acceptable | 2025-01-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-21 | Spain | Acceptable | 2025-01-21 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-04-17 | Acceptable 2024-11-04
|
2025-07-14 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-30 | Acceptable | 2025-05-20 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-05 | Spain | Acceptable | 2025-06-16 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-15 | Spain | Acceptable | 2025-10-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-22 | Spain | Acceptable | 2025-12-22 |