NCT02240472

Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

Active, enrolled NA Last updated 4 March 2025

What this trial tests

NA trial testing Omission of axillary clearance in Breast Cancer in 2,700 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 January 2015

Primary endpoint
31 December 2021

31 December 2031

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,700
Start date	27 January 2015
Primary completion	31 December 2021
Estimated completion	31 December 2031
Sites	33 locations across Denmark, Greece, Sweden

Drugs / interventions tested

• Omission of axillary clearance

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.

The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.

This study is a prospective international randomized trial including 3500 patients.

Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases.
   de Boniface J, Filtenborg Tvedskov T, Rydén L, Szulkin R, et al · · 2024 · cited 189× · PMID 38598571 · DOI 10.1056/nejmoa2313487
2. Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial.
   Henke G, Knauer M, Ribi K, Hayoz S, et al · · 2018 · cited 111× · PMID 30514362 · DOI 10.1186/s13063-018-3021-9
3. Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial.
   Appelgren M, Sackey H, Wengström Y, Johansson K, et al · · 2022 · cited 42× · PMID 35279508 · DOI 10.1016/j.breast.2022.02.013
4. Breast Cancer in Geriatric Patients: Current Landscape and Future Prospects.
   Abdel-Razeq H, Abu Rous F, Abuhijla F, Abdel-Razeq N, et al · · 2022 · cited 29× · PMID 36199974 · DOI 10.2147/cia.s365497
5. Completion axillary lymph node dissection for the identification of pN2-3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial.
   de Boniface J, Appelgren M, Szulkin R, Alkner S, et al · · 2024 · cited 26× · PMID 39121881 · DOI 10.1016/s1470-2045(24)00350-4
6. Predicting pathological axillary lymph node status with ultrasound following neoadjuvant therapy for breast cancer.
   Skarping I, Förnvik D, Zackrisson S, Borgquist S, et al · · 2021 · cited 20× · PMID 34120224 · DOI 10.1007/s10549-021-06283-8
7. AGO Recommendations for the Surgical Therapy of Breast Cancer: Update 2022.
   Banys-Paluchowski M, Thill M, Kühn T, Ditsch N, et al · · 2022 · cited 17× · PMID 36186147 · DOI 10.1055/a-1904-6231
8. Prediction of High Nodal Burden in Patients With Sentinel Node-Positive Luminal ERBB2-Negative Breast Cancer.
   Skarping I, Bendahl PO, Szulkin R, Alkner S, et al · · 2024 · cited 10× · PMID 39320882 · DOI 10.1001/jamasurg.2024.3944