Overview
Sponsor-declared trial summary
Breast Cancer
To evaluate the interest of [68Ga] Ga-NOTA-anti-HER2-sdAb for the prediction of invasive pathological complete response (ypT0/is ypN0) in HER2-positive early breast cancer
Key facts
- Sponsor
- Centre Henri Becquerel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AGIR avec Becquerel
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate the interest of [68Ga] Ga-NOTA-anti-HER2-sdAb for the prediction of invasive pathological complete response (ypT0/is ypN0) in HER2-positive early breast cancer
Conditions and MedDRA coding
Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Signed informed consent Performance status 0-1 Woman over 18 years old Histologically proven HER2 positive (IHC 3+ or IHC2+ and ISH +) early breast cancer Indication of neoadjuvant treatment with chemotherapy + anti-HER2 targeted therapy followed by surgery based on local Breast Tumor Board
Exclusion criteria 1
- Pregnant or breast-feeding women Patient non treated in curative intent History of homolateral breast cancer treated by surgery and/or radiation therapy Contraindication or known hypersensitivity to [68Ga]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients Known contraindication or hypersensitivity to [18F]F-FDG or any of its radiopharmaceutical excipients Patient under guardianship, curatorship or safeguard of justice Patient deprived of liberty Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint will evaluate the concordance rate between the response estimated by [⁶⁸Ga]Ga-NOTA-anti-HER2-sdAb PET-CT and the complete histological response (pCR) on the invasive component (ypT0/is ypN0).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11163219 · Product
- Active substance
- 68GA-NOTA-ABSCINT-HER2
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Authorisation status
- Not Authorised
- MA holder
- ABSCINT
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Henri Becquerel
- Sponsor organisation
- Centre Henri Becquerel
- Address
- Rue D Amiens
- City
- Rouen Cedex
- Postcode
- 76038
- Country
- France
Scientific contact point
- Organisation
- Centre Henri Becquerel
- Contact name
- Doriane Richard
Public contact point
- Organisation
- Centre Henri Becquerel
- Contact name
- Doriane Richard
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 42 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol _2025-523286-23-00_GATHER_public | 1.2 |
| Protocol (for publication) | D1_Protocol_2025-523286-23-00_GATHER | 1.2 |
| Protocol (for publication) | D1_Protocol_2025-523286-23-00_GATHER_TC | 1.2 |
| Protocol (for publication) | D1_Protocol-page-signature_2025-523286-23-00_GATHER | 1 |
| Protocol (for publication) | D1_SM_01_tableau_modification-protocole_2025-523286-23-00_GATHER | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2025-523286-23-00_GATHER | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_2025-523286-23-00_GATHER | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_2025-523286-23-00_GATHER_TC | 1.2 |
| Synopsis of the protocol (for publication) | D1_Resume-langage-simple_ 2025-523286-23-00_GATHER | 1.1 |
| Synopsis of the protocol (for publication) | D1_Synopsis_2025-523286-23-00_GATHER | 1.2 |
| Synopsis of the protocol (for publication) | D1_Synopsis_2025-523286-23-00_GATHER_public | 1.2 |
| Synopsis of the protocol (for publication) | D1_Synopsis_2025-523286-23-00_GATHER_TC | 1.2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-02 | France | Acceptable 2025-12-17
|
2026-01-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-11 | France | Acceptable 2026-04-23
|
2026-05-07 |