Omitting axillary surgery in breast cancer patients with complete response after treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether axillary lymph node dissection (ALND) can be safely omitted in breast cancer patients who achieve a pathological complete response (pCR) in their axillary lymph nodes after receiving neoadjuvant systemic therapy (NST). The study will enroll 92 female patients aged 18 to 70 with confirmed invasive breast cancer and positive axillary lymph nodes that convert to negative after treatment. Participants will undergo a Stained region Lymph Node Biopsy (SrLNB) and receive regional lymph node radiotherapy, followed by adjuvant therapies. Patients will be monitored for local-regional recurrence and long-term survival outcomes over three years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female aged between 18 and 70 years;
2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;
3. Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;
4. Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);
5. Positive axillary lymph nodes successfully stained by carbon nanoparticles injection;
6. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
7. Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0);
8. ECOG score 0 - 1;
9. Patients voluntarily participated in this study and signed the informed consent form

Exclusion Criteria:

1. Bilateral breast cancer;
2. Breast cancer during lactation period or pregnancy;
3. Physical examination or imaging examination confirmed presence of distant metastases;
4. Previous history of malignant tumor;
5. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
6. History of radiation therapy to the breast or chest;
7. Positive incision margins for breast-conserving surgery/mastectomy;
8. Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+);
9. Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons;
10. Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase（ALP） ≥ 2.5 times the upper limit of normal, total bile ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; Left Ventricular Ejection Fractions (LVEF) \< 50% in cardiac ultrasound;
11. Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection;
12. Without personal freedom and independent civil capacity;
13. Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Jue Wang, MD
• Email: wangjue200011@njmu.edu.cn
• Phone: +862568306360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.