Overview
Sponsor-declared trial summary
Patients with HER2-positive (HER2-pos) (cohort 1) or HER2-low defined as a score 1+ on immunohistochemistry [IHC] or as an IHC score 2+ and negative results on in situ hybridization (ISH) (cohort 2) ABC, and any hormone receptor (HR) status, who have progressed on trastuzumab deruxtecan (T-DXd). In addition to previous T-DXd, patients with HER2-pos tumors must have received prior treatment with trastuzumab (+/- pertuzumab) and taxanes and may have received T-DM1. Patients with HER2-low tumors must have received prior treatment with taxanes. Patients with HR-positive (HR+) and HER2-low tumor must have received prior treatment with endocrine therapy and CDK4/6 inhibitors.
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 21 Mar 2024 → ongoing
- Decision date (initial)
- 2024-01-10
- 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 HER2-positive (HER2-pos) (cohort 1) or HER2-low defined as a score 1+ on immunohistochemistry [IHC] or as an IHC score 2+ and negative results on in situ hybridization (ISH) (cohort 2) ABC, and any hormone receptor (HR) status, who have progressed on trastuzumab deruxtecan (T-DXd). In addition to previous T-DXd, patients with HER2-pos tumors must have received prior treatment with trastuzumab (+/- pertuzumab) and taxanes and may have received T-DM1. Patients with HER2-low tumors must have received prior treatment with taxanes. Patients with HR-positive (HR+) and HER2-low tumor must have received prior treatment with endocrine therapy and CDK4/6 inhibitors.
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 | 150 | 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 | 2024-03-21 | 2024-03-21 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-07 | France | Acceptable 2024-01-10
|
2024-01-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-16 | France | Acceptable 2024-01-10
|
2024-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-11 | France | Acceptable 2025-08-07
|
2025-09-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-03 | France | Acceptable 2025-08-07
|
2025-10-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-26 | France | Acceptable 2026-04-23
|
2026-05-05 |