Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
900
Countries
1
Sites
1
Breast cancer
Key facts
- Sponsor
- Uniwersytet Jagiellonski Collegium Medicum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Dec 2024 → ongoing
- Decision date (initial)
- 2024-05-27
- 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
Uniwersytet Jagiellonski Collegium Medicum
- Sponsor organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Address
- Ul. Sw. Anny 12
- City
- Cracow
- Postcode
- 31-008
- Country
- Poland
Scientific contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Elżbieta Łuczyńska
Public contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Jagiellońskie Centrum Wsparcia Badań Klinicznych
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 900 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Poland | 2024-12-13 | 2025-01-21 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-06 | Poland | Acceptable with conditions 2024-05-20
|
2024-05-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-15 | Poland | Acceptable 2024-09-13
|
2024-09-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-12 | Poland | Acceptable 2026-02-16
|
2026-02-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-23 | Poland | Acceptable 2026-02-16
|
2026-02-23 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-09 | Poland | Acceptable 2026-02-16
|
2026-03-09 |