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

Shanghai Jiao Tong University School of Medicine

Status

Enrolling

Conditions

Breast Cancer Invasive

Treatments

Device: 68Ga-GZMB PET/CT

Study type

Observational

Funder types

Other

Identifiers

NCT06725940

RJBC-GZMB

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.