A prospective, multicentre, non-randomised clinical trial suggests many women with hormone receptor-positive (HR+)/HER2-negative breast cancer and limited axillary lymph node involvement may be able to avoid axillary lymph node dissection (ALND), potentially reducing the risk of long-term complications while maintaining encouraging short-term locoregional outcomes.
Published in JAMA Surgery, the study found that nearly 70% of carefully selected patients with clinically node-positive (cN1) disease had only one or two positive sentinel lymph nodes at surgery, making them eligible to avoid ALND under the study protocol.
ALND has traditionally been considered the standard surgical approach for patients with palpable node-positive breast cancer. However, the procedure is associated with significant morbidity, including lymphoedema, shoulder dysfunction, pain and reduced arm mobility.
Expanding the role of sentinel lymph node biopsy
Previous landmark studies established that many patients with clinically node-negative breast cancer can safely avoid ALND when only one or two sentinel lymph nodes contain cancer. However, those trials excluded patients with clinically node-positive (cN1) disease, leaving ALND as the standard of care for this group.
Researchers sought to determine whether upfront sentinel lymph node biopsy (SLNB) could also be safely used in a carefully selected subset of patients with HR+/HER2− cN1 breast cancer who had three or fewer abnormal lymph nodes identified on preoperative axillary ultrasound.
Most patients avoided axillary dissection
The prospective, non-randomised trial enrolled 78 patients across four centres with biopsy-confirmed, palpable cN1 HR+/HER2− breast cancer.
All participants underwent upfront surgery with SLNB.
Key findings included:
- Sentinel lymph node biopsy was technically feasible in nearly all patients, with three or more sentinel lymph nodes retrieved in 96% of cases.
- Sixty-nine per cent of patients had only one or two positive sentinel lymph nodes.
- Overall, 59 of 78 patients (76%) underwent SLNB alone. Fifty-four met protocol criteria to omit ALND, while five who met criteria for ALND ultimately did not undergo the procedure because of patient preference or surgeon discretion.
- Among patients with at least 12 months of follow-up (median 25 months), there were no isolated axillary or locoregional recurrences.
Potential to reduce treatment-related morbidity
The findings suggest carefully selected patients may be candidates for further de-escalation of axillary surgery, although confirmation in randomised trials is still needed.
Importantly, the study demonstrated that careful preoperative selection using axillary ultrasound, combined with removal of any palpable abnormal nodes during surgery, enabled many patients to avoid more extensive axillary surgery while maintaining encouraging short-term locoregional control.
Longer follow-up still needed
The authors caution that the findings should not be generalised to all patients with node-positive breast cancer.
The study included only patients with HR+/HER2− disease, clinically palpable cN1 disease and no more than three abnormal lymph nodes identified on ultrasound. Patients with more advanced nodal involvement or locally advanced breast cancer were excluded.
In addition, the trial was non-randomised and involved just 78 patients, with a median follow-up of approximately two years. Longer follow-up and results from ongoing randomised studies, including the TAXIS trial, will be important to confirm the long-term oncological safety of omitting ALND in this patient population.
If confirmed, the approach could further reduce the need for axillary lymph node dissection and its associated morbidity among carefully selected patients with node-positive HR+/HER2− breast cancer.
Paper: Mamtani A, et al. Sentinel Lymph Node Biopsy for Patients With cN1 HR+/HER2− Breast Cancer and Palpable Adenopathy: A Nonrandomized Clinical Trial. JAMA Surg. 2026;161(7):662–668. Access online here.
