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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Podpisanie pisemnej zgody na uczestnictwo w badaniu
  • Kobieta w wieku 65 lat lub starszą
  • Przebyta operacja usunięcia raka piersi z potwierdzeniem przerzutów do węzłów chłonnych
  • Typ Luminal A (bez przerzutów do węzłów chłonnych) lub Luminal B (z przerzutami do węzłów chłonnych)
  • Wiek 70+ lat bez chemioterapii, dodatni hormonalny typ nowotworu, bez przerzutów
  • Ogólny stan zdrowia: ECOG 0-1 (pozwalający na codzienne aktywności)
  • Spodziewany czas przeżycia ponad 6 miesięcy
  • Testy laboratoryjne spełniające wymogi badania

✗ Disqualifies

  • Wcześniejsze leczenie chemioterapią przed operacją
  • Rak piersi w obu piersiach jednocześnie
  • Próbki tkanki przechowywane dłużej niż 3 lata
  • Zaburzenia psychiczne uniemożliwiające uczestnictwo w leczeniu
  • Inne choroby, leki lub wyniki badań mogące wpłynąć na wyniki, lub inne powody uznane za niezakwalifikowanie przez badacza

Simplified criteria — AI translation

Trial details

Minimum age
65 Years
Last updated (source)
March 24, 2025
Sex
Female only

Locations (1)

Qilu Hospital of Shandong University

Jinan, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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