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Clinical Trial · NCT07593976
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
Overview
The GATHER trial aim to evaluate the diagnostic performance of \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.
Sponsor
Centre Henri Becquerel
Phase
Phase 2
Contacts
Doriane Richard, PhD (CONTACT)
doriane.richard@chb.unicancer.fr
+33232082985
Florian Clatot, MD, PhD (PRINCIPAL_INVESTIGATOR)
Florian Clatot, MD, PhD (CONTACT)
florian.clatot@chb.uncancer.fr
+33232082981
ClinicalTrials.gov
NCT07593976Drug / Compound
NOTA-anti-HER2-sdAb
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- HER2
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA
Eligibility
Inclusion
- ECOG performance status of 0 or 1
- Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board
- Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification
Exclusion
- Lobular histology
- Patient not treated with curative intent
- History of ipsilateral breast cancer treated by surgery and/or radiotherapy
- Known contraindication or hypersensitivity to \[18F\]F-FDG or any of its radiopharmaceutical excipients
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