Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
48
Countries
5
Sites
16
Advanced or metastatic breast cancer
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Feb 2024 → ongoing
- Decision date (initial)
- 2023-08-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502465-18-00
- ClinicalTrials.gov
- NCT05870579
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or metastatic breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
5 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 9 | 5 |
| Germany | Ongoing, recruitment ended | 6 | 4 |
| Poland | Ongoing, recruitment ended | 2 | 1 |
| Portugal | Temporarily halted | 4 | 1 |
| Spain | Ongoing, recruitment ended | 13 | 5 |
| Rest of world
China, United States
|
— | 14 | — |
Investigational sites
Centre Regional Lutte Contre Le Cancer
#1004: Medical Oncology, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Institut Bergonie
#1002: Nuclear Medicine, 229 Cours De L Argonne, 33000, Bordeaux
Institut Curie
#1003: Nuclear Medicine, 35 Rue Dailly, 92210, Saint-Cloud
Institut De Cancerologie De L Ouest
#1000: Medical Oncology, Boulevard Jacques Monod, 44805, Saint Herblain
Centre Jean Perrin
#1001: Medical Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
University Hospital Cologne AöR
#2001: Klinik und Poliklinik für Nuklearmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Klinikum rechts der Isar der TU Muenchen AöR
#2002: Klinik und Poliklinik für Nuklearmedizin, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Erlangen AöR
2003; Frauenklinik und Poliklinik, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Universitaetsklinikum Essen AöR
#2000: Klinik für Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
#3000: Centrum Diagnostyki i Leczenia Chorób Piersi, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
#4000: Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Clinic De Barcelona
#6000: Servicio Oncología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
#6004: Servicio Oncología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
#6001: Servicio Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
#6002: Servicio Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
#6003: Servicio Oncología, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| France | 2024-03-18 | 2024-03-18 | 2026-04-07 | ||
| Germany | 2024-07-05 | 2024-07-05 | 2025-08-05 | ||
| Poland | 2025-04-15 | 2025-04-15 | 2025-11-13 | ||
| Portugal | 2023-11-13 | 2023-11-13 | 2025-03-17 | ||
| Spain | 2024-02-15 | 2024-02-15 | 2026-05-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-121867
- Halt date
- 2026-02-20
- Member states concerned
- Portugal
- Publication date
- 2026-03-05
- Reason
- Medicinal Product related
- Explanation
- Current site 68Ge/68Ga generator lacks sufficient elution capacity to meet the required activity
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-77268
- Halt date
- 2025-03-17
- Member states concerned
- Portugal
- Publication date
- 2025-04-01
- Reason
- Medicinal Product related
- Explanation
- Gallium-68 Generator supply issue
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-26 | Germany | Acceptable with conditions 2023-08-18
|
2023-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-23 | Germany | Acceptable 2023-11-24
|
2023-11-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-27 | Germany | Acceptable 2024-05-24
|
2024-05-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-13 | Germany | Acceptable 2024-10-07
|
2024-10-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-20 | Germany | Acceptable 2025-04-02
|
2025-04-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-05 | Germany | Acceptable 2025-06-18
|
2025-06-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-29 | Acceptable | 2025-08-08 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-11 | Acceptable | 2025-10-07 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-12-18 | Germany | Acceptable 2026-02-19
|
2026-02-19 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-09 | Germany | Acceptable 2026-02-19
|
2026-04-09 |