Overview
Sponsor-declared trial summary
Patients with hormone-receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-negative) advanced breast cancer (ABC) who have already received standard therapy for HR+/HER2-negative ABC, including only one line of chemotherapy for advanced/metastatic disease.
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
- 11 May 2021 → ongoing
- Decision date (initial)
- 2024-08-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505923-30-00
- EudraCT number
- 2020-005722-28
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with hormone-receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-negative) advanced breast cancer (ABC) who have already received standard therapy for HR+/HER2-negative ABC, including only one line of chemotherapy for advanced/metastatic disease.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
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
- Bureau projet Promotion- DRC
Public contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Bureau projet Promotion- DRC
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 139 | 11 |
| 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 | 2021-05-11 | 2021-05-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | France | Acceptable 2024-08-20
|
2024-08-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-19 | France | Acceptable 2024-11-26
|
2024-11-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-08 | France | Acceptable 2025-11-14
|
2025-11-19 |