Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
720
Countries
2
Sites
15
HER2-positive metastatic breast cancer (MBC) and early breast cancer (EBC)
Key facts
- Sponsor
- Aprogen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- completed 18 Apr 2025
- Decision date (initial)
- 2024-03-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HER2-positive metastatic breast cancer (MBC) and early breast cancer (EBC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aprogen Inc.
- Sponsor organisation
- Aprogen Inc.
- Address
- 545 Dunchon-Daero, Jungwon-Gu Jungwon-Gu
- City
- Seongnam-Si
- Postcode
- 13215
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Aprogen Inc.
- Contact name
- Senior Manager
Public contact point
- Organisation
- Aprogen Inc.
- Contact name
- Senior Manager
Locations
2 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 48 | 8 |
| Romania | Ended | 18 | 7 |
| Rest of world
Colombia, Argentina, Thailand, Turkey, Mexico, Brazil, South Africa, Malaysia, Chile, Peru, Philippines, Georgia, India
|
— | 654 | — |
Investigational sites
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department of Chemotherapy, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Szpital Rejonowy Im. Dr Jozefa Rostka W Raciborzu
Department of Chemotherapy, Ul. Gamowska 3, 47-400, Raciborz
Mruk-Med I Sp. z o.o.
N/A, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
N/A, Ul. Polnocna 8/3, 20-064, Lublin
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Department of Chemotherapy, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department of Clinical Oncology and Chemotherapy, Ul. Hubalczykow 1, 76-200, Slupsk
Instytut Centrum Zdrowia Matki Polki
Department of Clinical Oncology, Ul. Rzgowska 281/289, 93-338, Lodz
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department of Chemotherapy, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Spitalul Clinic Judetean Mures
Oncology, Strada Marinescu Gheorghe Nr. 3, 540142, Targu Mures
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Sigmedical Services S.R.L.
Oncology, Bis The Building Corp A, Strada Zamca Nr 21, Suceava
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Medisprof S.R.L.
Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-26 | Poland | Acceptable 2024-03-04
|
2024-03-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-22 | Poland | Acceptable 2024-03-04
|
2024-03-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-27 | Acceptable | 2024-07-01 |