Breast Cancer Lung MetastasisNCT07752966
Evaluation of a Genetic Risk Score for Lung Metastasis and Prognosis in Breast Cancer
An observational study of Breast Cancer Lung Metastasis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Lung Metastasis
- What is being tested?
- Standard management
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed, previously untreated early-stage breast cancer patients without distant metastasis, treated at Sun Yat-sen Memorial Hospital. Female, aged ≤70, ECOG ≤2. Approximately 330 participants will be enrolled consecutively.
Who may be able to join
- 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%;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a Genetic Risk Score Model for Predicting Pulmonary Metastasis and Overall Prognosis in Breast Cancer Patients: A Prospective Cohort Study
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.
- Conditions
- Breast Cancer Lung Metastasis
- Being tested
- Standard management
- Keywords
- Breast Cancer Lung Metastasis, A six-gene risk score model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard managementOther
Standard Management
| Study group | Role | What they receive |
|---|---|---|
| All Enrolled Early-Stage Breast Cancer Patients | All patients receive standard multidisciplinary treatment per institutional guidelines for early-stage breast cancer. Receives: Other: Standard management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Metastasis Incidence
Cumulative incidence of lung metastasis from the date of diagnosis to first radiographic or pathological confirmation. Lung metastasis is diagnosed by contrast-enhanced chest computed tomography (CT), positron emission tomography-computed tomography (PET-CT), or lung biopsy.
Measured: Up to 120 months
Area Under the Receiver Operating Characteristic (ROC) Curve of the Gene Risk Score for Predicting Lung Metastasis
The area under the ROC curve (AUC) of the six-gene risk score in predicting lung metastasis, using the occurrence of lung metastasis during follow-up as the gold-standard outcome. Sensitivity, specificity, positive predictive value, and negative predictive value will also be calculated.
Measured: Assessed at 1, 3, and 5 years (time-dependent ROC curves)
Lung Metastasis-Free Survival and Overall Survival
Lung metastasis-free survival is defined as the time from study enrollment to first imaging or pathological confirmation of lung metastasis. Overall survival is defined as the time from study enrollment to death from any cause.
Measured: Up to 120 months
Secondary outcomes (3)
Predictive Performance of the Gene Risk Score Across Molecular Subtypes
Evaluation of the six-gene risk score's predictive accuracy for lung metastasis in each molecular subtype (Luminal A, Luminal B, HER2-positive, and triple-negative breast cancer), as classified by ASCO/CAP guidelines. The area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value will be calculated for each subtype. The log-rank test will be used to compare lung metastasis incidence between high-risk and low-risk groups within each subtype.
Measured: Up to 120 months
Comparison of Predictive Performance Between the Gene Risk Score, Clinicopathological Factors, and Their Combination
Head-to-head comparison of three models in predicting lung metastasis: (1) a clinicopathological model incorporating TNM stage, molecular subtype, and Ki-67 index; (2) the six-gene risk score model; and (3) a combined model integrating both. Time-dependent ROC curves will be used to compare the AUCs at 3, 5, and 10 years, with differences assessed by the DeLong test. Net Reclassification Improvement (NRI) and Integrated Discrimination Improvement (IDI) will quantify the added value of the gene risk score beyond conventional factors.
Measured: 3, 5, and 10 years (time-dependent ROC curves)
Immunosuppressive Microenvironment Characteristics in High- versus Low-Risk Groups
Multiplex immunofluorescence staining will be performed on tumor tissue sections from 40 randomly selected patients per group to detect CD8 (cytotoxic T lymphocytes), PD-1 (exhausted T cells), PD-L1 (M2 macrophages and tumor cells), and CD68 (macrophages). Quantitative analysis will compare positive cell density per mm², the proportion of PD-1⁺CD8⁺ double-positive cells among CD8⁺ T cells, and the proportion of PD-L1⁺CD68⁺ double-positive cells among CD68⁺ macrophages between high-risk and low-risk groups using the Mann-Whitney U test. Spearman correlation will assess the relationship between continuous risk scores and immune cell densities.
Measured: At baseline (tissue samples collected at diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2038 (estimated)
- Study completion1 Oct 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Lung MetastasisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752966
- Sponsor's protocol ID
- SYSKY-2026-645-01
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Genetic Risk Score Model for Predicting Pulmonary Metastasis and Overall Prognosis in Breast Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07752966
- Acronym / sponsor ID
- SYSKY-2026-645-01
- Conditions
- Breast Cancer Lung Metastasis
- Keywords
- Breast Cancer Lung Metastasis, A six-gene risk score model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2038 (estimated)
- Study completion
- 1 Oct 2038 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Enrolled Early-Stage Breast Cancer Patients | – | Other: Standard managementAll patients receive standard multidisciplinary treatment per institutional guidelines for early-stage breast cancer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed, previously untreated early-stage breast cancer patients without distant metastasis, treated at Sun Yat-sen Memorial Hospital. Female, aged ≤70, ECOG ≤2. Approximately 330 participants will be enrolled consecutively.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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:
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard managementStandard Management | Other | All Enrolled Early-Stage Breast Cancer Patients |
Primary outcome
Lung Metastasis Incidence
Time frame: Up to 120 months
Cumulative incidence of lung metastasis from the date of diagnosis to first radiographic or pathological confirmation. Lung metastasis is diagnosed by contrast-enhanced chest computed tomography (CT), positron emission tomography-computed tomography (PET-CT), or lung biopsy.
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)
The area under the ROC curve (AUC) of the six-gene risk score in predicting lung metastasis, using the occurrence of lung metastasis during follow-up as the gold-standard outcome. Sensitivity, specificity, positive predictive value, and negative predictive value will also be calculated.
Lung Metastasis-Free Survival and Overall Survival
Time frame: Up to 120 months
Lung metastasis-free survival is defined as the time from study enrollment to first imaging or pathological confirmation of lung metastasis. Overall survival is defined as the time from study enrollment to death from any cause.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Lung Metastasis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang Gong, Professor (86+13925089353, gchang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Metastasis Incidence (time frame: Up to 120 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.