21-gene in Elder Breast Cancer Patients with Lymph Node Metastasis (QiluElderHope)

March 20, 2025 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jiang Zhu, M.D. & Ph.D.
Phone Number: （+86）18560085173
Email: zhujiang@qiluhospital.com

Study Contact Backup

Name: Xiao Wang, M.D. & Ph.D.
Phone Number: （+86）18560081170
Email: wangxiao08@sdu.edu.cn

Study Locations

China
- Shandong
  - Jinan, Shandong, China, 250012
    - Recruiting
    - Qilu Hospital of Shandong University
    - Contact:
      
      Siqi Cui
      
      Phone Number: （+86）18560085451
      
      Email: cuisiqi10135@qiluhospital.com
    - Contact:
      
      Song Zhao, M.D. & Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Qilu hospital of Shandong University or its medical alliance hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
21-gene assay in elder breast cancer with axillary lymph node metastasis 21-gene assay will be performed not only in primary cancer site in breast but also in metastatic lymph nodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whether elderly Luminal-A breast cancer patients with axillary lymph node metastasis could benefit from 21-gene assay. Time Frame: From enrollment to 80 years old（Average life expectancy）or mortality.	All analyses will be conducted using SPSS 22.0. Comparisons between groups will be reported with 95% confidence intervals and p-values. Continuous variables will be presented as mean ± SD or median (min, max) based on distribution normality. Categorical variables will be described using frequencies (%). Disease-Free Survival (DFS) Unit of measure: Months from postoperative baseline Assessment: Time to first radiological recurrence (RECIST v1.1) or death Method: Kaplan-Meier analysis with log-rank test	From enrollment to 80 years old（Average life expectancy）or mortality.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whether elderly Luminal-A breast cancer patients with axillary lymph node metastasis could benefit from 21-gene assay Time Frame: From enrollment to 80 years old（Average life expectancy）or mortality.	Overall Survival (OS) Unit of measure: Months from enrollment Assessment: Time to all-cause mortality Method: Kaplan-Meier analysis	From enrollment to 80 years old（Average life expectancy）or mortality.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

Principal Investigator: Jiang Zhu, M.D. & Ph.D., Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)