Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Breast cancer
Key facts
- Sponsor
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512152-38-00
- EudraCT number
- 2020-000276-38
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
Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Sponsor organisation
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Address
- Travesia Da Choupana S/n
- City
- Santiago De Compostela
- Postcode
- 15706
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Contact name
- Virginia Pubul Núñez
Public contact point
- Organisation
- Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
- Contact name
- Virginia Pubul Núñez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Complexo Hospitalario Universitario De Santiago
Medicina Nuclear, Calle Choupana Da S/n, 15706, Santiago De Compostela
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-04 | Spain | Acceptable 2024-11-15
|
2024-11-15 |