GzmB-PET/CT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer (GzmB-PET4BC)

Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET/CT With Granzyme B Imaging Probe

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Invasive
• Intervention / Treatment: Device: 68Ga-GZMB PET/CT

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Xiaosong Chen; Phone Number: +86-21-64370045-602102; Email: chenxiaosong0156@hotmail.com
• Study Contact Backup: Name: Siji Zhu; Phone Number: +86-21-64370045-602102; Email: zsj_mu@yeah.net

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
    • Contact: Siji Zhu; Phone Number: +86-21-64370045-602102; Email: zsj_mu@yeah.net
    • Contact: Xiaosong Chen; Phone Number: +86-21-64370045-602102; Email: xiaosongchen0156@hotmail.com
    • Principal Investigator: Xiaosong Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients receiving neoadjuvant treatment

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study cohort; Patient receiving 68Ga-GZMB PET/CT	Device: 68Ga-GZMB PET/CT; 68Ga-GZMB PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR	Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR	Sensitivity and specificity of 68Ga-GZMB PET/CT in assessing pathological complete response after neoadjuvant therapy for breast cance	through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT	through study completion, an average of 1 year
Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes	Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Xiaosong Chen, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; PET/CT; neoadjuvant treatment; pCR; Granzyme B
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RJBC-GZMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No