RecruitingNCT06891651

21-gene in Elder Breast Cancer Patients With Lymph Node Metastasis

Clinical Cohort Study of 21-gene Assay in Predicting the Prognosis of Elder Luminal-A Breast Cancer Patients With Axillary Lymph Node Metastasis


Sponsor

Qilu Hospital of Shandong University

Enrollment

35 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a single-center, bidirectional cohort study. It aims to include 35 elderly (≥65 years old) Luminal A type breast cancer patients with axillary lymph node metastasis after surgery as the research subjects. After signing the informed consent, the patients who meet the inclusion criteria will have their various clinical and pathological data collected (preoperative imaging examinations, clinical and pathological information of the patients, basic disease conditions and medication strategies, surgical records, postoperative planned treatment plans and actual treatment situations, etc.), and their real adjuvant treatment situations (whether chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc. were performed after surgery) will be followed up and recorded. At the same time, paraffin tissues of breast cancer and metastatic lymph nodes of the patients will be collected from the pathology department of our hospital for 21-gene assay, and the recurrence risk index of the primary lesion and metastatic lymph nodes will be obtained using the risk index calculation logic of Amoy Diagnostics Company. An assessment will be conducted every 12 months after surgery until disease recurrence. After disease recurrence, survival follow-up will be conducted every three months until the patient's death. The predictive value of 21-gene assay for patient survival and whether chemotherapy is beneficial will be evaluated based on the follow-up data of the patients.


Eligibility

Sex: FEMALEMin Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a 21-gene test (a genomic test that predicts how likely a cancer is to return) can help older breast cancer patients with lymph node spread decide whether they need chemotherapy after surgery, potentially sparing them from unnecessary treatment. **You may be eligible if...** - You are a woman aged 65 or older - You have had surgery for breast cancer with lymph node involvement confirmed - Your cancer is a hormone receptor-positive (ER/PR positive), HER2-negative type (Luminal A, Luminal B, or certain others) - You are postmenopausal **You may NOT be eligible if...** - You are under 65 years of age - Your cancer is a different subtype (e.g., HER2-positive or triple-negative) - You have not had surgery yet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06891651


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