Ongoing clinical trials on axillary management

Area of Science:

• Oncology
• Surgical Oncology
• Breast Cancer Management

Background:

• Breast cancer management has seen significant surgical de-escalation over 50 years, particularly for axillary staging.
• Axillary lymph node dissection (ALND) has been largely replaced by sentinel lymph node biopsy (SLNB) in early-stage breast cancer (EBC) with clinically uninvolved axilla (cN0).
• Studies show that patients with isolated tumor cells or micrometastases on SLN, and even some with 1-2 positive SLNs (e.g., Z0011 trial criteria), can avoid ALND.

Purpose of the Study:

• To review the evolution and current status of axillary surgery de-escalation in breast cancer management.
• To examine ongoing clinical trials investigating non-surgical or less invasive axillary management strategies.
• To assess the potential for further reduction or elimination of axillary surgery in both neoadjuvant and non-neoadjuvant settings.

Main Methods:

• Comprehensive literature search of PubMed, Medline, Cochrane Library, and ClinicalTrials.Gov up to May 2020.
• Analysis of ongoing trials focusing on patients not undergoing neoadjuvant chemotherapy, including eligibility criteria, comparison arms, and expected outcomes.
• Examination of ongoing trials in the neoadjuvant setting, particularly in the post-neoadjuvant context for patients with initially involved axilla (cN1→cN0).

Main Results:

• The study describes ongoing trials for patients not receiving neoadjuvant chemotherapy, detailing their parameters and anticipated results.
• Ongoing trials for patients undergoing neoadjuvant chemotherapy were also examined similarly.
• Evidence suggests that in specific scenarios, even after neoadjuvant chemotherapy, SLNB can be safely performed in patients whose axilla converted from clinically positive to negative (cN1→cN0).

Conclusions:

• Significant progress has been made in reducing axillary surgery for breast cancer.
• Further research and ongoing trials are crucial to address remaining questions and generalize findings.
• The ultimate goal is to safely de-escalate axillary surgery further, potentially leading to its elimination in the future for select breast cancer patients.