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

NCT07593976

RecruitingPhase 2

Sponsor: Centre Henri Becquerel

Conditions: Breast Cancer

Interventions: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography

Countries: France

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Female aged 18 years or older
* Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification
* Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board
* ECOG performance status of 0 or 1
* Affiliated to or beneficiary of a social protection scheme
* Written informed consent signed prior to any study-specific procedure

Exclusion Criteria:

* Pregnant or breastfeeding women

  * Patient not treated with curative intent
  * History of ipsilateral breast cancer treated by surgery and/or radiotherapy
  * Lobular histology
  * Known contraindication or 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
  * Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals
  * Patient under guardianship, curatorship, or judicial protection
  * Patient deprived of liberty
  * Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers

Locations (1)

Rouen, France