Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
120
Countries
1
Sites
15
Hormone receptor-positive early breast cancer in post-menopausal women
Key facts
- Sponsor
- Laboratorios Farmaceuticos Rovi S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Jun 2026 → ongoing
- Decision date (initial)
- 2026-03-31
- 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
Hormone receptor-positive early breast cancer in post-menopausal women
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Farmaceuticos Rovi S.A.
- Sponsor organisation
- Laboratorios Farmaceuticos Rovi S.A.
- Address
- Calle De Julian Camarillo 35
- City
- Madrid
- Postcode
- 28037
- Country
- Spain
Scientific contact point
- Organisation
- Laboratorios Farmaceuticos Rovi S.A.
- Contact name
- Rovi Medical Department
Public contact point
- Organisation
- Laboratorios Farmaceuticos Rovi S.A.
- Contact name
- Rovi Medical Department
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 57 | 15 |
| Rest of world
Georgia, United States, Serbia
|
— | 63 | — |
Investigational sites
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Leon
Oncology, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitari General De Catalunya
Oncology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Universitario Fundacion Alcorcon
Oncology, Calle Budapest 1, 28922, Alcorcon
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Salut Sant Joan De Reus
Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Oncology, Carrer Del Doctor Joan Soler 1-3, 08243, Manresa
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Virgen De Las Nieves
Oncology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
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 | 2026-06-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-12 | Spain | Acceptable 2026-03-23
|
2026-03-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-23 | Spain | Acceptable | 2026-05-19 |