New Imaging Method for Early HER2 Positive Breast Cancer
Evaluation of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT for Predicting Pathological Complete Response After Neoadjuvant Chemotherapy in HER2 Positive Early Breast Cancer
Recruiting
Phase 2Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
42 (estimated)
Sponsor
Centre Henri Becquerel · Other
Who this trial is looking for
This trial is looking for women with early HER2 positive breast cancer to see if a special imaging method can help predict their treatment response after chemotherapy. Participants will need to undergo the imaging test and follow their recommended treatment plan.
Are You a Good Fit for This Trial?
You may be able to join if
I am a female aged 18 years or older
I have been diagnosed with HER2-positive early breast cancer
My doctor says I need neoadjuvant chemotherapy with anti-HER2 therapy
I am able to give signed consent to join this trial
You may not be able to join if
I am pregnant or breastfeeding
I have had breast cancer treated before
I have lobular breast cancer
I am allergic to the study imaging drug or its components
I am currently in another clinical trial with radiopharmaceuticals
I have a legal guardian or am under judicial protection
I am unable to understand the study due to language or psychological issues
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 multidisciplin…
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
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