HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 70 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. All patients receiving T-DXd treatment must meet current clinical indications. After screening and enrollment, participants will undergo FDG-PET scans and free-of-charge HER2-PET scans prior to T-DXd treatment, with tissue biopsies performed as needed. Participants will receive single-agent T-DXd treatment until disease progression, with additional tissue biopsies performed as needed.This study will integrate and analyze patients' baseline clinical characteristics, treatment efficacy, and prognostic information, along with HER2 expression levels and HER2 expression heterogeneity as assessed by HER2-PET, to evaluate the feasibility of guiding T-DXd treatment in patients with advanced breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony nowotwór piersi, który nie może być usunięty chirurgicznie, rozprzestrzeniający się lokalnie lub przerzutujący, z objawami HER2-dodatnimi lub HER2-niskiego poziomu
- •Wcześniejsze leczenie: dla HER2-dodatnich — co najmniej jedna terapia celowana; dla HER2-niskich — co najmniej jedna linia leczenia systemowego lub wznowa w ciągu 6 miesięcy po chemioterapii
- •Ogólny stan zdrowia pozwalający na aktywność zwykłą lub z ograniczeniami (ECOG 0-1)
- •Potwierdzony postęp nowotworu w obrazowaniu po ostatnim leczeniu
- •Spodziewana długość życia co najmniej 12 tygodni
- •Co najmniej jeden mierzalny guz (nie poprzednio naświetlany) o średnicy ≥10 mm lub węzły chłonne o krótkiej osi ≥15 mm
- •Prawidłowa funkcja serca (frakcja wyrzutowa ≥50%) i badania laboratoryjne (morfologia, wątróbka, nerki) w normie
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 14, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Fudan Cancer Hospital
Shanghai, China
Trial contact
Juan Jin Attending physician
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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