Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
382
Countries
2
Sites
10
Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-positive Early Stage or Locally Advanced Breast Cancer
Key facts
- Sponsor
- Biocon Biologics UK Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- completed 24 Feb 2025
- Decision date (initial)
- 2023-11-22
- 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
Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-positive Early Stage or Locally Advanced Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072740 | Locally advanced breast cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Biocon Biologics UK Limited
- Sponsor organisation
- Biocon Biologics UK Limited
- Address
- 16 Great Queen Street
- City
- London
- Postcode
- WC2B 5AH
- Country
- United Kingdom
Scientific contact point
- Organisation
- Biocon Biologics UK Limited
- Contact name
- Dr. Anoop Chullikana
Public contact point
- Organisation
- Biocon Biologics UK Limited
- Contact name
- Jayanti Panda
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 31 | 7 |
| Romania | Ended | 15 | 3 |
| Rest of world
Taiwan, Philippines, Georgia, India
|
— | 336 | — |
Investigational sites
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Oddział Onkologii Klinicznej, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Pratia S.A.
Pratia MCM Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Onkologia Kliniczna, Os. Zlotej Jesieni 1, 31-826, Cracow
Instytut Msf Sp. z o.o.
N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Centra Medyczne Medyceusz Sp. z o.o.
n/a, Ul. Bazarowa 9, 91-053, Lodz
Mruk-Med I Sp. z o.o.
Poradnia Onkologiczna, Ul. Gen. Mariana Langiewicza 61, 35-021, Rzeszow
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Sigmedical Services S.R.L.
Oncology, Bis The Building Corp A, Strada Zamca Nr 21, Suceava
Spital Clinic Militar De Urgenta Dr. Constantin Papilian Cluj Napoca
Oncology & Chemotherapy, Strada General Traian Mosoiu No 22, 400132, Cluj-Napoca
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-28 | Poland | Acceptable with conditions 2023-11-20
|
2023-11-22 |