Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
155
Countries
1
Sites
4
breast cancer
Key facts
- Sponsor
- Centre Antoine Lacassagne
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517481-41-00
- EudraCT number
- 2017-002037-31
- ClinicalTrials.gov
- NCT04198727
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
breast cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Antoine Lacassagne
- Sponsor organisation
- Centre Antoine Lacassagne
- Address
- 33 Avenue De Valombrose
- City
- Nice Cedex 2
- Postcode
- 06189
- Country
- France
Scientific contact point
- Organisation
- Centre Antoine Lacassagne
- Contact name
- Dr Anne CREISSON
Public contact point
- Organisation
- Centre Antoine Lacassagne
- Contact name
- Dr Anne CREISSON
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 155 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Polyclinique Saint George
Medical Oncology, 2 avenue de Rimiez, 06105, NICE
Centre azureen de cancerologie
Oncology, 1 Place Du Docteur Jean Luc Broquerie, 06250, Mougins
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Hospitalier D'Antibes Juan Les Pins
Oncology, 107 Avenue De Nice, 06606, Antibes Cedex
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 | 2024-10-02 | 2024-10-02 | 2025-02-28 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | France | Acceptable 2024-09-27
|
2024-10-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-05 | France | Acceptable 2024-12-30
|
2024-12-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-17 | France | Acceptable 2026-04-07
|
2026-04-23 |