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

March 8, 2023 updated by: Jana de Boniface, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

805

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Helsingborg, Sweden
        • Helsingborgs Hospital
      • Kalmar, Sweden
        • Kalmar Hospital
      • Karlskrona, Sweden
        • Karlskrona Hospital
      • Kristianstad, Sweden
        • Kristianstad Hospital
      • Lidköping, Sweden
        • Lidkoping Hospital
      • Linköping, Sweden
        • Linkoping University Hospital
      • Lund, Sweden
        • Lund and Malmö University Hospital
      • Skövde, Sweden
        • Skövde Hospital
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital
      • Stockholm, Sweden
        • Capio St Görans Hospital
      • Stockholm, Sweden
        • Danderyds Hospital AB
      • Stockholm, Sweden
        • Southern General Hospital
      • Sundsvall, Sweden
        • Sundsvall Hospital
      • Uddevalla, Sweden
        • Uddevalla Hospital
      • Umeå, Sweden
        • Umeå University Hospital
      • Uppsala, Sweden
        • Akademiska Universitetssjukhuset
      • Varberg, Sweden
        • Varberg Hospital
      • Västervik, Sweden
        • Västervik Hospital
      • Västerås, Sweden
        • Västmanlands Hospital
      • Växjö, Sweden
        • Växjö Hospital
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)
  • Histopathology results demonstrate SN micrometastases.
  • Patients who undergo mastectomy (protocol change from April 2017 onwards)
  • The patient must have given verbal and written consent.

Exclusion Criteria:

  • Preoperatively diagnosed lymph node metastases.
  • Sentinel node metastases > 2 mm.
  • Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
  • History of previous breast cancer.
  • Pregnancy.
  • Bilateral breast cancer where any of the other exclusion criteria applies to either side.
  • Medical contraindication for systemic adjuvant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omission of axillary clearance
No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases
Procedure: Omission of axillary clearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: Five years
Five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Axillary recurrence rate
Time Frame: Five years
Five years

Other Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Five years
Five years
Breast cancer-specific survival
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Uppsala University
Centrallasarettet Västerås

Investigators

  • Principal Investigator: Jana M de Boniface, MD, PhD, Karolinska Institutet
  • Principal Investigator: Jan Frisell, Professor, Karolinska Institutet
  • Principal Investigator: Leif Bergkvist, Professor, Uppsala University
  • Principal Investigator: Yvette Andersson, MD, PhD, Västmanlands Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENOMIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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