Overview
Sponsor-declared trial summary
Patients with hormone-receptor negative and HER2-negative (IHC 0, 1+ or IHC 2+/ISH-) breast cancer with early relapse while on (neo) adjuvant systemic treatment or within 12 months from the end of all treatments with curative intent.
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jun 2024 → ongoing
- Decision date (initial)
- 2024-01-15
- 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
Patients with hormone-receptor negative and HER2-negative (IHC 0, 1+ or IHC 2+/ISH-) breast cancer with early relapse while on (neo) adjuvant systemic treatment or within 12 months from the end of all treatments with curative intent.
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
- DRC-PROMOTION- Affaires réglementaires
Public contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- DRC-PROMOTION- Affaires réglementaires
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 50 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-06-17 | 2024-07-05 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | France | Acceptable 2024-01-15
|
2024-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-23 | France | Acceptable 2024-04-29
|
2024-04-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-24 | France | Acceptable 2024-04-29
|
2024-05-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-06-13 | France | Acceptable 2024-04-29
|
2024-06-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-18 | France | Acceptable 2025-10-02
|
2025-10-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-20 | France | Acceptable | 2026-04-24 |