Clinical trial • Phase II • Oncology

68GA-NOTA-ABSCINT-HER2 for Breast cancer | HER2-positive early breast cancer

Phase II trial of 68GA-NOTA-ABSCINT-HER2 for Breast cancer | HER2-positive early breast cancer. 42 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer | HER2-positive early breast cancer
Trial Stage
Phase II
Drug Modality
Radiopharmaceutical | Other antibody

Key dates

Initial CTIS Submission Date
02-10-2025
First CTIS Authorization Date
26-01-2026

Trial design

Phase II trial across 1 site in France.

Target Sample Size
42

Eligibility

Recruits 42 Vulnerable populations excluded: patients under guardianship, curatorship or safeguard of justice; patients deprived of liberty; patients unable to understand the study or comply with trial constraints (language, psychological, geographical problems). Consent: signed informed consent required from adult participants (women ≥18); subject information and informed consent form available for adults. No paediatric assent procedures (trial enrols adults only)..

Pregnancy Exclusion
Pregnant or breast-feeding women
Vulnerable Population
Vulnerable populations excluded: patients under guardianship, curatorship or safeguard of justice; patients deprived of liberty; patients unable to understand the study or comply with trial constraints (language, psychological, geographical problems). Consent: signed informed consent required from adult participants (women ≥18); subject information and informed consent form available for adults. No paediatric assent procedures (trial enrols adults only).

Inclusion criteria

  • {"criterion_text":"- Signed informed consent\n- Performance status 0-1\n- Woman over 18 years old\n- Histologically proven HER2 positive (IHC 3+ or IHC2+ and ISH +) early breast cancer\n- Indication of neoadjuvant treatment with chemotherapy + anti-HER2 targeted therapy followed by surgery based on local Breast Tumor Board"}

Exclusion criteria

  • {"criterion_text":"- Pregnant or breast-feeding women\n- Patient non treated in curative intent\n- History of homolateral breast cancer treated by surgery and/or radiation therapy\n- Contraindication or known hypersensitivity to [68Ga]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients\n- Known contraindication or hypersensitivity to [18F]F-FDG or any of its radiopharmaceutical excipients\n- Patient under guardianship, curatorship or safeguard of justice\n- Patient deprived of liberty\n- Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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).","definition_or_measurement_approach":"Concordance rate between PET-CT response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb and complete histological response (pCR) on the invasive component defined as ypT0/is ypN0."}

Recruitment

Planned Sample Size
42
Recruitment Window Months
30
Consent Approach
Signed informed consent required from adult participants (women ≥18). Subject information and informed consent form for adults available (L1_SIS and ICF adults document). No paediatric consent/assent.

Geography

Total Number Of Sites
1
Total Number Of Participants
42

France

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
148
Number Of Sites
1
Number Of Participants
42

Sites

Site Name
Centre Henri Becquerel
Department Name
Oncologie Médicale
Contact Person Name
Florian Clatot

Sponsor

Primary sponsor

Full Name
Centre Henri Becquerel
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Third parties

  • {"country":"","full_name":"AGIR avec Becquerel","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
ABSCINT (68Ga-ABS011)
Active Substance
68GA-NOTA-ABSCINT-HER2
Modality
Radiopharmaceutical | Other antibody
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
Intravenous

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