Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Temporarily halted
Participants planned
40
Countries
1
Sites
9
TRIPLE-NEGATIVE OR HR+/HER2– ADVANCED/METASTATIC BREAST CANCER
Key facts
- Sponsor
- Medica Scientia Innovation Research S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jan 2025 → ongoing
- Decision date (initial)
- 2024-11-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516322-60-00
- ClinicalTrials.gov
- NCT06612203
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
TRIPLE-NEGATIVE OR HR+/HER2– ADVANCED/METASTATIC BREAST CANCER
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medica Scientia Innovation Research S.L.
- Sponsor organisation
- Medica Scientia Innovation Research S.L.
- Address
- Carrer De Pere IV 128 3rd Floor
- City
- Barcelona
- Postcode
- 08005
- Country
- Spain
Scientific contact point
- Organisation
- Medica Scientia Innovation Research S.L.
- Contact name
- Alicia Garcia
Public contact point
- Organisation
- Medica Scientia Innovation Research S.L.
- Contact name
- Meritxell Aguiló García
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Temporarily halted | 40 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Arnau De Vilanova De Valencia
Medical Oncology, Calle De San Clemente 12, 46015, Valencia
Hospital Beata Maria Ana
Medical Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos S/N, 29010, Malaga
Hospital Del Mar
Medical Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Institut Catala D'oncologia
Medical Oncology, Avinguda De Franca S/n, 17007, Girona
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 | 2025-01-17 | 2025-02-06 | 2025-11-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-107349
- Halt date
- 2025-11-06
- Planned restart
- 2026-04-30
- Member states concerned
- Spain
- Publication date
- 2025-11-20
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This decision follows the outcome of the Study Steering Committee meeting held on 06/11/2025, during which the Committee recommended implementing additional measures to better characterize study pharmacokinetic and pharmacodynamic data for the combination. These recommendations will be incorporated into the corresponding protocol amendment and applied to newly enrolled patients.
- Follow-up measures
- Protocol amendment will be developed to implement additional safety measures with the aim of improving patient’s safety.
There is 1 patient ongoing, and since the patient is receiving the first level dose, the patient will continue with the treatment with no changes. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-14 | Spain | Acceptable 2024-11-06
|
2024-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-02 | Spain | Acceptable 2024-11-06
|
2025-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-08 | Spain | Acceptable 2025-10-13
|
2025-10-30 |