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

NCT06725940 | Recruiting

• 1 other identifier: RJBC-GZMB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Invasive

Keywords

breast cancer; Granzyme B; PET/CT; neoadjuvant treatment; pCR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity and specificity of 68Ga-GZMB PET/CT for pCR

  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

  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

  through study completion, an average of 1 year

Study Arms (1)

Study cohort

Patient receiving 68Ga-GZMB PET/CT

Device: 68Ga-GZMB PET/CT

Interventions

68Ga-GZMB PET/CT DEVICE

68Ga-GZMB PET/CT

Study cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients receiving neoadjuvant treatment

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lipodystrophy, Congenital Generalized

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipodystrophy; Skin Diseases, Metabolic; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Xiaosong Chen

  Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaosong Chen

CONTACT

+86-21-64370045-602102; chenxiaosong0156@hotmail.com

Siji Zhu

CONTACT

+86-21-64370045-602102; zsj_mu@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 10, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)