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Evaluation of a new radiotracker for predicting complete response after neoadjuvant chemotherapy in HER2-positive early breast cancer
EU CTIS ID: 2025-523286-23-00
What this study is testing
To evaluate the interest of [68Ga] Ga-NOTA-anti-HER2-sdAb for the prediction of invasive pathological complete response (ypT0/is ypN0) in HER2-positive early breast cancer
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent Performance status 0-1 Woman over 18 years old Histologically proven HER2 positive (IHC 3+ or IHC2+ and ISH +) early breast cancer Indication of neoadjuvant treatment with chemotherapy + anti-HER2 targeted therapy followed by surgery based on local Breast Tumor Board
You likely can't join if
- Pregnant or breast-feeding women Patient non treated in curative intent History of homolateral breast cancer treated by surgery and/or radiation therapy Contraindication or known 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 Patient under guardianship, curatorship or safeguard of justice Patient deprived of liberty Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.