Evaluation of a Genetic Risk Score for Lung Metastasis and Prognosis in Breast Cancer

Официальное название

Evaluation of a Genetic Risk Score Model for Predicting Pulmonary Metastasis and Overall Prognosis in Breast Cancer Patients: A Prospective Cohort Study

Обзор

The goal of this observational study is to validate the predictive ability of a six-gene risk score model for lung metastasis in patients with early-stage breast cancer. The main questions it aims to answer are: Does the gene risk score accurately identify patients at high risk of developing lung metastases? Does it predict lung metastasis-free survival and overall survival in these patients? How does its performance compare with traditional clinical indicators (such as TNM stage, molecular subtype, and Ki-67) across different breast cancer subtypes? Participants will be women aged 70 years or younger with newly diagnosed, non-metastatic early-stage breast cancer. They will receive standard treatment according to routine clinical practice. A single tumor tissue sample (from biopsy or surgery) will be collected for testing the expression of six specific genes, and a risk score will be calculated to classify patients into high-risk or low-risk groups. All participants will be followed for up to 120 months to monitor lung metastasis occurrence and survival outcomes. In addition, the study will explore differences in immune microenvironment characteristics between the two risk groups using a subset of tumor samples.

Вмешательства

• Другое Standard management
  Standard Management

Первичные конечные точки

• Lung Metastasis Incidence [Срок оценки: Up to 120 months]
• Area Under the Receiver Operating Characteristic (ROC) Curve of the Gene Risk Score for Predicting Lung Metastasis [Срок оценки: Assessed at 1, 3, and 5 years (time-dependent ROC curves)]
• Lung Metastasis-Free Survival and Overall Survival [Срок оценки: Up to 120 months]

Вторичные конечные точки (3)

• Predictive Performance of the Gene Risk Score Across Molecular Subtypes [Срок оценки: Up to 120 months]
• Comparison of Predictive Performance Between the Gene Risk Score, Clinicopathological Factors, and Their Combination [Срок оценки: 3, 5, and 10 years (time-dependent ROC curves)]
• Immunosuppressive Microenvironment Characteristics in High- versus Low-Risk Groups [Срок оценки: At baseline (tissue samples collected at diagnosis)]

Критерии участия

Критерии включения

• Female, age 18 to 70 ;
• Histopathologically confirmed previously untreated primary early-stage breast cancer, excluding occult breast cancer, inflammatory breast cancer, and Paget's disease of the breast;
• Histopathologically confirmed primary early-stage breast cancer with no evidence of distant metastasis;
• At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
• Left ventricular ejection fraction (LVEF) ≥ 55%;
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2× upper limit of normal (ULN); alkaline phosphatase ≤ 2× ULN; total bilirubin ≤ 2× ULN; serum creatinine ≤ 1.5× ULN;
• Adequate bone marrow reserve: white blood cell count ≥ 3.0×10⁹/L, absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L;
• Ability to understand the study procedures and willingness to participate voluntarily by signing the informed consent form.

Критерии исключения

• History of any other malignancy within the past 5 years, except for breast cancer;
• Evidence of metastatic breast cancer by imaging or pathology;
• Uncontrolled pleural effusion, pericardial effusion, or ascites;
• Severe cardiac disease or conditions that would preclude tolerance to chemotherapy, including but not limited to:

• Life-threatening arrhythmias or higher-grade atrioventricular block.
• Clinically significant valvular heart disease.
• Transmural myocardial infarction on electrocardiogram.
• Uncontrolled hypertension.
• Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752966 · SYSKY-2026-645-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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