Actively Recruiting

Age: 65Years +
FEMALE
ID06891651

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

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

35

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating elderly female patients aged 65 years and older with Luminal A type breast cancer that has spread to lymph nodes after surgery. This observational study aims to assess whether a 21-gene assay can predict survival outcomes and the benefits of chemotherapy in these patients. The study focuses on clinical and pathological data including imaging, treatment plans, and medication strategies to better understand disease progression and treatment impact. The study collects paraffin tissue samples from both the primary breast cancer and metastatic lymph nodes for a 21-gene assay, which calculates a recurrence risk index. Patients will be followed every 12 months after surgery to monitor for disease recurrence. After recurrence, survival is followed every three months until death. This approach allows researchers to observe real-world treatment effects and outcomes without administering experimental treatments. Participants will have their clinical information and treatment details recorded, including whether chemotherapy, radiotherapy, endocrine therapy, or targeted therapy were used after surgery. Follow-up includes regular assessments and survival tracking until the patient reaches age 80 or passes away. Data collected will help evaluate the predictive value of the 21-gene assay and guide treatment decisions for elderly breast cancer patients with lymph node involvement.

CONDITIONS

Brief 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 surgery for breast cancer with histologically confirmed axillary lymph node metastasis
  • Postoperative immunohistochemical typing and staging meet criteria for Luminal A or Luminal B, Her-2 negative subtypes as specified
  • ECOG performance status score of 0 or 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 and follow-up
  • History or evidence of disease, treatment, or lab abnormalities interfering with participation
  • Other conditions deemed unsuitable or potentially risky for study participation by researchers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 month

21-gene assay will be performed on the primary breast cancer site and metastatic lymph nodes to assess prognosis.

1 visit (in-person)

Long-term Monitoring

Duration - From enrollment to 80 years old or mortality

Participants are observed for health outcomes up to average life expectancy or until mortality.

Periodic visits as needed

Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

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Research Team

J

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

X

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

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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