Actively Recruiting

Age: 65Years +
FEMALE
NCT06891651

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

Led by Qilu Hospital of Shandong University · Updated on 2025-03-24

35

Participants Needed

1

Research Sites

526 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, age 65 years or older
  • Signed written informed consent
  • Underwent radical breast cancer surgery with histologically confirmed axillary lymph node metastasis
  • Postoperative immunohistochemical and pTNM staging meeting one of the following: Luminal A type (ER and PR positive ≥20%, Her-2 negative, Ki67 <15%, pTanyNanyM0); Luminal B Her-2 negative with ER and PR positive ≥20%, Ki67 ≤30%, pTanyN1M0; or age ≥70 with Luminal B Her-2 negative, ER and PR positive ≥20%, Ki67 ≤30%, pTanyNanyM0; or age ≥70 unable or refusing chemotherapy with ER or PR positive, pTanyNanyM0
  • ECOG score 0-1
  • Expected survival time greater than 6 months
Not Eligible

You will not qualify if you...

  • Received preoperative neoadjuvant therapy
  • Bilateral breast cancer
  • Paraffin tissue specimens stored for more than 3 years at study start
  • Mental disorders preventing cooperation with treatment or follow-up
  • History or evidence of disease, treatments, or abnormal lab results interfering with trial results or preventing full participation
  • Other conditions deemed unsuitable by researchers or posing potential risks

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

J

Jiang Zhu, M.D. & Ph.D.

CONTACT

X

Xiao Wang, M.D. & Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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