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Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

NCT02466737 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5505

Last updated 2026-05-01

No results posted yet for this study

Summary

Although there is no doubt that the presence of lymph node metastases worsens prognosis of a patient, unambiguous evidence to support lymph node dissection is still lacking. For many solid tumors, the role of lymph node dissection is yet controversial, and may depend on the tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast cancer is now considered as staging procedure that does not seem to influence breast cancer mortality. Women with breast cancer have benefitted greatly from a series of carefully performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA is to show that less axillary surgery is better, in that oncological outcomes are the same and less surgical intervention will result in fewer surgical complications.

Conditions

Interventions

PROCEDURE

no axillary surgery versus SLNB

in cases with newly diagnosed breast cancer and clinically negative axillary status

PROCEDURE

SLNB versus completion ALND

in cases with 1-3 macrometastases in sentinel lymph nodes

Sponsors & Collaborators

  • German Cancer Aid

    collaborator OTHER

  • GBG Forschungs GmbH

    collaborator OTHER

  • University of Rostock

    lead OTHER

Principal Investigators

  • Toralf Reimer, MD, PhD · University Medical Center Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2024-08-30
Completion
2029-12-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466737 on ClinicalTrials.gov