Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
43
Countries
1
Sites
1
Metastatic breast cancer
Key facts
- Sponsor
- GE Healthcare Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 15 Nov 2024 → 3 Oct 2025
- Decision date (initial)
- 2024-10-01
- 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
Metastatic breast cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
GE Healthcare Limited
- Sponsor organisation
- GE Healthcare Limited
- Address
- Pollards Wood, Nightingales Lane Nightingales Lane
- City
- Chalfont St. Giles
- Postcode
- HP8 4SP
- Country
- United Kingdom
Scientific contact point
- Organisation
- GE Healthcare Limited
- Contact name
- Yaron Raiter, MD
Public contact point
- Organisation
- GE Healthcare Limited
- Contact name
- Yaron Raiter, MD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 43 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-11-15 | 2025-01-24 | 2025-10-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | Sweden | Acceptable 2024-09-30
|
2024-10-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-03 | Sweden | Acceptable 2024-09-30
|
2024-12-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-27 | Sweden | Acceptable 2024-09-30
|
2025-02-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-15 | Sweden | Acceptable 2025-06-27
|
2025-06-27 |