Using PET/CT to assess breast cancer treatment effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of 68Ga-GZMB PET/CT imaging in determining how well patients with invasive breast cancer respond to neoadjuvant therapy. It aims to identify the optimal SUVmax threshold for predicting pathological complete response (pCR) to treatment. By providing a non-invasive method to assess treatment efficacy, the study seeks to improve patient management and outcomes in breast cancer care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Xiaosong Chen — Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
• Study coordinator: Xiaosong Chen
• Email: chenxiaosong0156@hotmail.com
• Phone: +86-21-64370045-602102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.