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Patients in this arm will be treated by completion axillary clearance after a sentinel node biopsy showing 1-2 nodes with macrometastasis

Patients in this arm will not undergo further axillary surgery after a sentinel node biopsy showing 1-2 nodes with macrometastasis

The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis

Omission of axillary clearance

Jana de Boniface, PhD

Jan Frisell, Professor

Leif Bergkvist, Professor

Yvette Andersson, PhD

Lisa Ryden, Professor

Malin Sund, Professor

Olofsson Roger, PhD

Johan Ahlgren, PhD

Dan Lundstedt, PhD

Peer Christiansen, Professor

Tove Tvedskov Filtenborg, MD

Michalis Kontos, PhD

Birgitte Offersen, Professor

Thorsten Kühn, Professor

Toralf Reimer, Professor

Oreste Gentilini

Roland Reitsamer

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.

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

Survival and Axillary Recurrence Following Sentinel Node-positive Breast Cancer Without Completion Axillary Lymph Node Dissection - a Randomized Study of Patients With Macrometastases in the Sentinel Node

death due to breast cancer in both arms measured at a median follow-up of 5, 10 and 15 years

Breast cancer recurrence rate in both arms after a median follow-up of 5, 10 and 15 years

The rate of axillary relapse in specific after a median follow-up of 5, 10 and 15 years

The rate of overall deaths after a median follow-up of 5, 10 and 15 years

The Swedish Research Council

Swedish Cancer Foundation

Nordic Cancer Union

Karolinska Institutet

Associate Professor

Neoplasm Micrometastasis

Neoplastic Processes

No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases

Jana M de Boniface, MD, PhD

Yvette Andersson, MD, PhD

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.

From April 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into SENOMIC. The inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in SENOMIC anymore. Recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.

Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis

Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.	NCT02240472	Breast Cancer	Omission of axi...	18 Years -	Karolinska Institutet
Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis	NCT02049632	Breast Cancer	Omission of axi...	18 Years -	Karolinska Institutet
Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.	NCT02240472	Breast Cancer	Omission of axi...	18 Years -	Karolinska Institutet

Spots Global Cancer Trial Database for omission of axillary clearance