Trial results investigating surgical breast resection with or without axillary lymph node excision for Breast Cancer were posted on ClinicalTrials.gov on 2025-10-20. The study found a significantly higher rate of axillary recurrence in patients who did not undergo axillary lymph node excision, with a Hazard Ratio of 3.067.
Background
Breast cancer treatment often involves surgical resection, and the management of regional lymph nodes is a critical component. A key question in the locoregional treatment of operable breast cancer, particularly in specific patient populations, is the necessity of systematic axillary lymph node excision. This procedure, while important for staging and local disease control, can be associated with potential complications. This trial aimed to evaluate if systematic axillary lymph node excision could be safely avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50.
Trial design
This Phase 3 randomized trial, which was terminated, enrolled 625 participants with Breast Cancer. The study compared two surgical approaches: conventional breast resection with axillary lymph node excision versus conventional breast resection without axillary lymph node excision. The trial specifically focused on evaluating if systematic axillary lymph node excision could be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50.
Key results
The trial reported the following key measurements:
- Number of Deaths:
- In the Conventional Surgery WITH Axillary Lymph Node Excision group, there were 6 deaths.
- In the Conventional Surgery WITHOUT Axillary Lymph Node Excision group, there were 17 deaths.
- Rate of Axillary Recurrence:
- In the Conventional Surgery WITH Axillary Lymph Node Excision group, there were 0 participants with axillary recurrence.
- In the Conventional Surgery WITHOUT Axillary Lymph Node Excision group, there were 7 participants with axillary recurrence.
A key analysis using the Log Rank method showed a Hazard Ratio (HR) of 3.067 (95.0% Confidence Interval: 1.4 to 6.7) for the comparison between the two groups, with a p-value of 0.013.
What this means
The results suggest that for the studied population of menopausal women older than 50 with operable breast cancer smaller than 10 mm, avoiding systematic axillary lymph node excision significantly increased the risk of axillary recurrence. The Hazard Ratio of 3.067 indicates a substantially higher risk of recurrence without the excision. Furthermore, the observed difference in the number of deaths, with 17 in the group without excision compared to 6 in the group with excision, alongside the 7 axillary recurrences versus 0, points towards the importance of axillary lymph node excision in this context for disease control and patient outcomes. The termination of the trial might reflect these findings.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT00210236, titled "Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer", were posted on 2025-10-20 on clinicaltrials.gov.