Granzyme B-PET: Predicting Immunotherapy Efficacy in TNBC
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
This study plans to enroll 30 patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who are scheduled to receive at least two cycles of a regimen containing an immune checkpoint inhibitor (ICI). All ICI treatments must be administered in accordance with current clinical indications. For patients who intend to participate in a clinical trial involving an ICI, they must meet the eligibility criteria of that specific trial protocol. After screening and enrollment, participants will undergo a \[68Ga\]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT) scan before initiating the ICI-containing regimen and again after Cycle 2 (C2). Participants will continue the ICI regimen until disease progression, with tissue biopsies performed as needed. By integrating patients' baseline clinical characteristics, treatment outcomes, and prognostic information, this study aims to conduct a comprehensive analysis. The objective is to investigate whether the following factors, as assessed by Granzyme B PET/CT, can serve as early predictors of response to immunotherapy in patients with advanced breast cancer: baseline Granzyme B expression levels, immunotherapy-activated Granzyme B levels after C2, and the heterogeneity of Granzyme B expression at baseline and after C2.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzona histologicznie choroba nowotworowa piersi nienadająca się do operacji, z przerzutami lub zaawansowana, ujemna w testach na receptory hormonalne i Her-2
- •Lekarz zdecydował o leczeniu terapią immunologiczną, na co najmniej 2 cykle
- •Status zdrowotny ECOG 0 lub 1 (pacjent może wykonywać normalne czynności)
- •Widoczny postęp choroby w obrazowaniu lub niepowodzenie poprzedniego leczenia
- •Spodziewana długość życia co najmniej 12 tygodni
- •Co najmniej jeden zmierzalny guz nie poddawany wcześniej radioterapii, widoczny w badaniach obrazowych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 15, 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: 7/16/2026.
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