Six-Gene clue: could a simple test forecast lung spread in breast cancer?
NCT ID NCT07752966
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This study is testing whether a six-gene risk score, calculated from a tumor tissue sample, can predict which women with early-stage breast cancer are more likely to develop lung metastasis. Researchers will follow 330 women aged 18 to 70 for up to 120 months, tracking lung metastasis and survival. The goal is to see if this genetic test adds value beyond standard clinical factors like tumor stage and subtype, potentially helping tailor future monitoring and treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A six-gene risk score test on tumor tissue
- What this could lead to
- If successful, this could give doctors a new tool to identify breast cancer patients at higher risk of lung metastasis, potentially guiding more personalized follow-up and treatment decisions.
- What could go wrong
- This is an observational study, so it cannot prove the test changes outcomes. The risk score may not perform better than existing clinical indicators, and results may not apply to all breast cancer subtypes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2038
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female, age 18 to 70 ; 2. Histopathologically confirmed previously untreated primary early-stage breast cancer, excluding occult breast cancer, inflammatory breast cancer, and Paget's disease of the breast; 3. Histopathologically confirmed primary early-stage breast cancer with no evidence of distant metastasis; 4. At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2; 6. Left ventricular ejection fraction (LVEF) ≥ 55%; 7. 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; 8. 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; 9. Ability to understand the study procedures and willingness to participate voluntarily by signing the informed consent form. Exclusion Criteria: 1. History of any other malignancy within the past 5 years, except for breast cancer; 2. Evidence of metastatic breast cancer by imaging or pathology; 3. Uncontrolled pleural effusion, pericardial effusion, or ascites; 4. Severe cardiac disease or conditions that would preclude tolerance to chemotherapy, including but not limited to: 1. Life-threatening arrhythmias or higher-grade atrioventricular block. 2. Clinically significant valvular heart disease. 3. Transmural myocardial infarction on electrocardiogram. 4. Uncontrolled hypertension. 5. Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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