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NCT Number: NCT06725940

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-GZMB PET/CT

Device

68Ga-GZMB PET/CT

Primary outcomes

  1. Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pCR

    Time frame: through study completion, an average of 1 year

    Optimal SUVmax threshold of 68Ga-GZMB PET/CT for predicting pathological complete response after neoadjuvant therapy in breast cancer

Secondary outcomes

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

    Time frame: through study completion, an average of 1 year

    Sensitivity and specificity of 68Ga-GZMB PET/CT in assessing pathological complete response after neoadjuvant therapy for breast cance

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after 68Ga-GZMB PET/CT

    Time frame: 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

  3. Correlation between the efficacy of 68Ga-GZMB PET/CT in predicting pathological complete response and tumor-infiltrating lymphocytes

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: GzmB-PET4BC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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