Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
4
Pre and post-menopausal women with resectable primary breast cancer and presence of residual disease after neoadjuvant chemotherapy
Key facts
- Sponsor
- Solti Group
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Dec 2018 → 18 Mar 2025
- Decision date (initial)
- 2024-04-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508550-25-00
- EudraCT number
- 2018-001300-10
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pre and post-menopausal women with resectable primary breast cancer and presence of residual disease after neoadjuvant chemotherapy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Solti Group
- Sponsor organisation
- Solti Group
- Address
- Calle Balmes 89 Planta 1 Puerta 2
- City
- Barcelona
- Postcode
- 08008
- Country
- Spain
Scientific contact point
- Organisation
- Solti Group
- Contact name
- SOLTI Start-Up Group
Public contact point
- Organisation
- Solti Group
- Contact name
- SOLTI Start-Up Group
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 30 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| Spain | 2018-12-10 | 2025-03-18 | 2018-12-20 | 2022-02-01 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-04 | Spain | Acceptable 2024-04-26
|
2024-04-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-09 | Spain | Acceptable 2024-04-26
|
2024-10-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-15 | Spain | Acceptable 2024-04-26
|
2024-10-15 |