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Granzyme B-PET: Predicting Immunotherapy Efficacy in TNBC

NCT07705438 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-07-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

[68Ga]Ga-DOTA-GSI PET/CT (Granzyme B PET/CT)

Granzyme B is a highly specific cytotoxic molecule. By binding to Granzyme B, Granzyme B-PET can visualize the distribution and activity of this enzyme within the tumor microenvironment on PET images. Performing Granzyme B-PET scans before and after immunotherapy allows for the monitoring of changes in active intratumoral immune cells during treatment. This, in turn, helps to assess whether the therapy has effectively activated the immune system and the extent of tumor cell killing. Granzyme B-PET images provide a measure of intratumoral Granzyme B uptake, thereby enabling an objective evaluation of the cytotoxic capacity of immune cells.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2027-05-28
Completion
2027-05-28

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705438 on ClinicalTrials.gov