Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
4
Untreated small triple negative breast cancer
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 6 Dec 2021 → ongoing
- Decision date (initial)
- 2024-04-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512082-14-00
- EudraCT number
- 2020-006106-23
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Untreated small triple negative breast cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Gustave Roussy
- Sponsor organisation
- Institut Gustave Roussy
- Address
- 114 Rue Edouard Vaillant
- City
- Villejuif
- Postcode
- 94800
- Country
- France
Scientific contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Dr Joana M Ribeiro
Public contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Dr Joana M Ribeiro
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 100 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Bergonie
ONCOLOGIE, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
ONCOLOGIE, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
ONCOLOGIE, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Jean Perrin
ONCOLOGIE, 58 Rue Montalembert, 63000, Clermont-Ferrand
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 | 2021-12-06 | 2024-04-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-12 | France | Acceptable 2024-04-26
|
2024-04-26 |