Clinical trial · Observational
GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer
Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe
NCT06725940CI-TRIAL-00083522GzmB-PET4BCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the efficacy of 68Ga-GZMB PET/CT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Invasive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-GZMB PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study cohort
- description
- Patient receiving 68Ga-GZMB PET/CT
- interventionNames
- Device: 68Ga-GZMB PET/CT
Primary outcomes (1)
- measure
- Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR
- timeFrame
- through study completion, an average of 1 year
- description
- Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer
Secondary outcomes (3)
- measure
- Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR
- timeFrame
- through study completion, an average of 1 year
- description
- Sensitivity and specificity of 68Ga-GZMB PET/CT in assessing pathological complete response after neoadjuvant therapy for breast cance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age 16-65 * histologically confirmed unilateral primary invasive breast cancer * Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy * complete clinical and histo-pathological information * ECOG 0-1 within 10 days from the beginning of the study * Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10\^9/L, Neutrophil count ≥ 1.5×10\^9/L, Hemoglobin level ≥ 90g/L; Platelet count (PLT) ≥ 80×10\^9/L; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, Total bilirubin ≤ 1.5 times the upper limit of normal, Serum creatinine ≤ 1.5 times the upper limit of normal, and Creatinine clearance rate \> 50ml/min. * The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form Exclusion Criteria: * bilateral or metastatic (stage IV) breast cancer * There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer * Severe systemic infection or other uncontrolled diseases * Patients with psychiatric disorders or those unable to comply with treatment due to other reasons * Known allergy or intolerance to the drug or its excipients * Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past * Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial. * Patients deemed unsuitable for participation in this study by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.