Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06891651

21-gene in Elder Breast Cancer Patients With 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Siqi Cui

CONTACT

[email protected]

(+86)18560085451

Song Zhao, M.D. & Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Luminal A type (ER and PR positive with a positive rate ≥ 20%, Her-2 gene negative, Ki67 < 15%), with pTNM staging of pTanyNanyM0.
  • 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.
  • 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.
  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

(+86)18560085173

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

CONTACT

[email protected]

(+86)18560081170

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Acronym: QiluElderHope

Important dates

Study start
2024
Primary completion
2026
Study completion
2034
First posted
Mar 24, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.