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Clinical cohort study of 21-gene assay in predicting the prognosis of elder Luminal-A breast cancer patients with axillary lymph node metastasis

Clinical cohort study of 21-gene assay in predicting the prognosis of elder Luminal-A breast cancer patients with axillary lymph node metastasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098218
Enrollment
Unknown
Registered
2025-03-04
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elder breast cancer with lymph node metastasis

Interventions

Observations group:None

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent; 2. Female, age >= 65 years; 3. Breast cancer 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 postoperative histology confirmed with axillary lymph node metastasis; 4. Postoperative immunohistochemical typing and pTNM staging are consistent with: - (1) Patients with Luminal type A (ER and PR positive with a positivity rate of >= 20%, Her2 gene negative, Ki67 = 20%, Ki67 = 70 years, Luminal B, Her2 geno-negative type, and meet ER and PR positivity with a positivity rate of >= 20%, Ki67 = 70 years, but who refuse or are unable to tolerate chemotherapy treatment with a positive ER or PR with a TNM stage of pTanyNanyM0; 5. ECOG score of 0 - 1 point; 6. The expected survival time is > 6 months.

Exclusion criteria

Exclusion criteria: 1.Patients who have received preoperative neoadjuvant therapy in the past; 2.Patients with bilateral breast cancer; 3.Patients whose paraffin tissue specimens have been stored for more than 3 years at the start of the project; 4.Patients with mental disorders who are unable to cooperate with subsequent treatment and follow-up; 5.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 investigator, or those considered to have other potential risks and thus not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Overall survival rate;

Countries

China

Contacts

Public ContactJiang Zhu

Qilu Hospital of Shandong University

zhujiang@qiluhospital.com+86 531 82166381

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026