Omission of ALND in Breast Cancer Patients With Axillary pCR

Official title

Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy

Overview

This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.

Interventions

• Procedure Stained region Lymph Node Biopsy (SrLNB)
  Before NST, carbon nanoparticles suspension would be injected into the cortex of positive lymph nodes for staining under ultrasound guidance. Marked lymph nodes will be removed and biopsied after NST.
• Radiation Regional lymph node radiotherapy (RNI) including the axilla
  RNI including the axilla covers the supraclavicular region and entire axillary lymphatic drainage area (region I, II and III) ,and is at a dose of 50 Gy/25 times, with additional prophylactic irradiation of the internal breast lymphatic drainage area for eligible patients.

Primary outcome measures

• iDFS: invasive Disease-Free Survival after breast surgery [Time frame: Up to 3 years after surgery]

Secondary outcome measures (4)

• LRR: Local-Regional Recurrence after breast surgery [Time frame: Up to 3 years after surgery]
• BCRL: Breast Cancer Related Lymphedema [Time frame: Up to 3 years after surgery]
• Quality of life (QoL) [Time frame: Up to 3 years after surgery]
• Patient-reported arm morbidity [Time frame: Up to 3 years after surgery]

Eligibility criteria

Inclusion criteria

• Female aged between 18 and 70 years;
• Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;
• Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;
• Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);
• Positive axillary lymph nodes successfully stained by carbon nanoparticles injection;
• 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;
• Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0);
• ECOG score 0 - 1;
• Patients voluntarily participated in this study and signed the informed consent form

Exclusion criteria

• Bilateral breast cancer;
• Breast cancer during lactation period or pregnancy;
• Physical examination or imaging examination confirmed presence of distant metastases;
• Previous history of malignant tumor;
• History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;
• History of radiation therapy to the breast or chest;
• Positive incision margins for breast-conserving surgery/mastectomy;
• Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+);
• Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons;
• 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;
• Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection;
• Without personal freedom and independent civil capacity;
• Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

• Ma L, Chen R, Wang M, Li X, Zheng R, Wang L, Ding J, Yao H, Gong Y, Wang Y, Sheng X, Wang J, Zha X. Omission of axillary lymph node dissection in patients with breast cancer with axillary pathological complete response confirmed by stained region lymph node biopsy after neoadjuvant systemic therapy (SrLNB study): study protocol for a single-arm, single-centre, phase-II trial. BMJ Open. 2025 Mar 31 PMID 40164484

Identifiers

NCT: NCT05939830 · SrLNB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗