Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study
Brief Summary:
Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.
However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.
This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.