XCancer

Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer

Description:

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

Government Study Link:

NCT07593976 - Click here to see study on

ClinicalTrials.gov

NOTA-anti-HER2-sdAb

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA
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