Predicting Complete Response in HER2+ Early Breast Cancer Using a Gallium PET/CT Scan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In women with HER2-positive early breast cancer, neoadjuvant chemotherapy is commonly used, and achieving a pathological complete response is linked to a better outlook. The trial evaluates the diagnostic performance of a novel HER2-targeted PET tracer, [68Ga]Ga-NOTA-anti-HER2-sdAb, to predict pCR after neoadjuvant therapy. This is a phase 2 interventional study assessing whether this imaging approach can non-invasively forecast treatment response and potentially guide future de-escalation of surgery. Participants will undergo the new PET/CT scan as part of their care plan to see if imaging results align with pCR. The study aims to pave the way for more personalized treatment strategies if successful.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Henri Becquerel
  Rouen, France Recruiting

Study contacts

• Principal investigator: Florian Clatot, MD, PhD — Centre Henri Becquerel
• Study coordinator: Florian Clatot, MD, PhD
• Email: florian.clatot@chb.uncancer.fr
• Phone: +33232082981

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.