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

Summary

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.

Conditions

• Breast Cancer

Interventions

PROCEDURE

Omission of axillary clearance

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

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• Swedish Cancer Foundation

  collaborator OTHER

• Nordic Cancer Union

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Jana de Boniface, PhD · Karolinska Institutet

• Jan Frisell, Professor · Karolinska University Hospital

• Leif Bergkvist, Professor · Central Hospital Västerås

• Yvette Andersson, PhD · Central Hospital Västerås

• Lisa Ryden, Professor · Lund University

• Malin Sund, Professor · Umeå University Hospital

• Olofsson Roger, PhD · Sahlgrenska University Hospital

• Johan Ahlgren, PhD · Region Örebro County

• Dan Lundstedt, PhD · Sahlgrenska University Hospital

• Peer Christiansen, Professor · Aarhus University Hospital, Denmark

• Tove Tvedskov Filtenborg, MD · Rigshospitalet Copenhagen, Dnmark

• Michalis Kontos, PhD · University of Athens

• Birgitte Offersen, Professor · University of Aarhus

• Thorsten Kühn, Professor · Klinikum Esslingen

• Toralf Reimer, Professor · Universität Rostock

• Oreste Gentilini · San Raffaele Hospital, Milano

• Roland Reitsamer · Universitätsklinikum Salzburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-27

Primary Completion

2021-12-31

Completion

2031-12-31

Countries

• Denmark
• Greece
• Sweden

Study Locations