21-gene assay in elderly breast cancer patients with 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
This study is trying to see how a special gene test can help doctors understand the risk of breast cancer coming back in older women who have had surgery for a specific type of breast cancer that has spread to their lymph nodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06891651 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on elderly women aged 65 and older who have undergone surgery for Luminal A type breast cancer with axillary lymph node metastasis. It aims to collect clinical and pathological data, including imaging examinations and treatment plans, to assess the real-world adjuvant treatment situations of these patients. Additionally, paraffin tissues from breast cancer and metastatic lymph nodes will be analyzed using a 21-gene assay to evaluate the recurrence risk index. The study will follow these patients to gather comprehensive data on their outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 65 and older with Luminal A type breast cancer and confirmed axillary lymph node metastasis after surgery.
Not a fit: Patients with breast cancer types other than Luminal A or those who are younger than 65 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the recurrence risk and optimal treatment strategies for elderly breast cancer patients with lymph node metastasis.
How similar studies have performed: While similar studies have explored the use of gene assays in breast cancer, this specific approach focusing on elderly patients with lymph node metastasis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Jiang Zhu, M.D. & Ph.D. — Qilu Hospital of Shandong University
- Study coordinator: Jiang Zhu, M.D. & Ph.D.
- Email: zhujiang@qiluhospital.com
- Phone: （+86）18560085173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.