Evaluation of a Genetic Risk Score for Lung Metastasis and Prognosis in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard management.
- Who it may be relevant to
- Registry conditions: Breast Cancer Lung Metastasis. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Genetic Risk Score Model for Predicting Pulmonary Metastasis and Overall Prognosis in Breast Cancer Patients: A Prospective Cohort Study
Overview
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.
Interventions
- Other Standard management
Standard Management
Primary outcome measures
- Lung Metastasis Incidence [Time frame: Up to 120 months]
- Area Under the Receiver Operating Characteristic (ROC) Curve of the Gene Risk Score for Predicting Lung Metastasis [Time frame: Assessed at 1, 3, and 5 years (time-dependent ROC curves)]
- Lung Metastasis-Free Survival and Overall Survival [Time frame: Up to 120 months]
Secondary outcome measures (3)
- Predictive Performance of the Gene Risk Score Across Molecular Subtypes [Time frame: Up to 120 months]
- Comparison of Predictive Performance Between the Gene Risk Score, Clinicopathological Factors, and Their Combination [Time frame: 3, 5, and 10 years (time-dependent ROC curves)]
- Immunosuppressive Microenvironment Characteristics in High- versus Low-Risk Groups [Time frame: At baseline (tissue samples collected at diagnosis)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07752966 · SYSKY-2026-645-01