21-gene assay in elderly breast cancer patients with lymph node metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on elderly women aged 65 and older who have undergone surgery for Luminal A type breast cancer with axillary lymph node metastasis. It aims to collect clinical and pathological data, including imaging examinations and treatment plans, to assess the real-world adjuvant treatment situations of these patients. Additionally, paraffin tissues from breast cancer and metastatic lymph nodes will be analyzed using a 21-gene assay to evaluate the recurrence risk index. The study will follow these patients to gather comprehensive data on their outcomes post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Sign a written informed consent；
* Female, age ≥ 65 years old；
* Patients who have undergone radical surgery for breast cancer (radical surgery refers to modified radical mastectomy, radical mastectomy or simple mastectomy + axillary lymph node dissection), and have been histologically confirmed to have axillary lymph node metastasis after surgery；
* Postoperative immunohistochemical typing and pTNM staging meet the following criteria:

  1. Luminal A type (ER and PR positive with a positive rate ≥ 20%, Her-2 gene negative, Ki67 \< 15%), with pTNM staging of pTanyNanyM0.
  2. Or Luminal B, Her-2 gene negative type, with ER and PR positive and a positive rate ≥ 20%, Ki67 ≤ 30%, and pTNM staging of pTanyN1M0.
  3. Or age ≥ 70 years old, Luminal B, Her-2 gene negative type, with ER and PR positive and a positive rate ≥ 20%, Ki67 ≤ 30%, and pTNM staging of pTanyNanyM0.
  4. Or age ≥ 70 years old, but refuse or are unable to tolerate chemotherapy treatment, ER or PR positive, with pTNM staging of pTanyNanyM0；
* ECOG score 0-1；
* Expected survival time \> 6 months.

Exclusion Criteria:

* Patients who have received preoperative neoadjuvant therapy in the past;
* Patients with bilateral breast cancer;
* Patients whose paraffin tissue specimens have been stored for more than 3 years at the start of the project;
* Patients with mental disorders who are unable to cooperate with subsequent treatment and follow-up;
* Patients with a history or evidence of disease, treatment or abnormal laboratory test values that may interfere with the trial results or prevent full participation in the study, or other situations deemed unsuitable for inclusion by the researcher, or those considered to have other potential risks and thus not suitable for participation in this study.

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jiang Zhu, M.D. & Ph.D. — Qilu Hospital of Shandong University
• Study coordinator: Jiang Zhu, M.D. & Ph.D.
• Email: zhujiang@qiluhospital.com
• Phone: （+86）18560085173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.