Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

May 3, 2018 updated by: Maastricht University Medical Center

Clinically Node Negative Breast Cancer Patients Undergoing Breast Conserving Therapy: Sentinel Lymph Node Procedure Versus Follow-Up.

STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.

PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate.

HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1644

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 Contact

  • Name: Marjolein L Smidt, MD, PhD
  • Phone Number: +31433877477

Study Locations

  • Netherlands
      • Almere, Netherlands
        • Not yet recruiting
        • Flevoziekenhuis
      • Amsterdam, Netherlands
        • Recruiting
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate
      • Breda, Netherlands
        • Not yet recruiting
        • Amphia Ziekenhuis
      • Den Bosch, Netherlands
        • Not yet recruiting
        • Jeroen Bosch Ziekenhuis
      • Den Haag, Netherlands
        • Recruiting
        • Haga ziekenhuis
      • Deventer, Netherlands
        • Recruiting
        • Deventer Ziekenhuis
      • Eindhoven, Netherlands
        • Not yet recruiting
        • Catharina Ziekenhuis
      • Eindhoven, Netherlands
        • Recruiting
        • Maxima Medisch Centrum
      • Gouda, Netherlands
        • Not yet recruiting
        • Groene Hart Ziekenhuis
      • Groningen, Netherlands
        • Not yet recruiting
        • UMC Groningen
      • Haarlem, Netherlands
        • Not yet recruiting
        • Spaarne Gasthuis
      • Leiden, Netherlands
        • Not yet recruiting
        • Alrijne
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • Not yet recruiting
        • Radboud UMC
      • Nijmegen, Netherlands
        • Not yet recruiting
        • Canisius-Wilhelmina Ziekenhuis
      • Roermond, Netherlands
        • Recruiting
        • Laurentius Ziekenhuis
      • Utrecht, Netherlands
        • Not yet recruiting
        • Diakonessenhuis
      • Utrecht, Netherlands
        • Not yet recruiting
        • UMC Utrecht
      • Woerden, Netherlands
        • Recruiting
        • Zuwehofpoort ziekenhuis
      • Zwolle, Netherlands
        • Recruiting
        • Isala Klinieken
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Recruiting
        • Maastricht University Medical Centre+
        • Contact:
          • Marjolein L Smidt, MD, PhD
          • Phone Number: +31433877477
        • Principal Investigator:
          • Marjolein L Smidt, MD, PhD

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

Female

Description

Inclusion Criteria:

  • Female
  • Aged 18 years or older
  • Pathologically confirmed invasive breast carcinoma
  • A clinical T1-2 tumor
  • Will be treated with lumpectomy and whole breast radiotherapy
  • Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
  • Written informed consent

Exclusion Criteria:

  • Clinically node positive pre-operative
  • Bilateral breast cancer
  • Evidence of metastatic disease
  • History of invasive breast cancer
  • Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
  • Pregnant or nursing
  • Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
  • Unable or unwilling to give informed consent

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline
Procedure: Sentinel lymph node procedure
Sentinel lymph node procedure according to the Dutch breast cancer guideline
No Intervention: No sentinel lymph node procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional recurrence rate
Time Frame: Up to ten years
Regional recurrence is defined as tumour recurrence and as residual tumour that became clinically apparent in ipsilateral axillary, infraclavicular and supraclavicular lymph nodes (pathologically proven).
Up to ten years

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Maastricht University
Borstkanker Onderzoek Groep
Dutch Cancer Society

Investigators

  • Principal Investigator: Hans JW de Wilt, MD, PhD, Radboud University Medical Centre, Nijmegen, The Netherlands
  • Principal Investigator: Marjolein L Smidt, MD, PhD, Maastricht University Medical Centre, Maastricht, the Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2015

Primary Completion (Anticipated)

April 1, 2027

Study Completion (Anticipated)

April 1, 2027

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOOG 2013-08 (Other Identifier: Dutch Breast Cancer Trialists' Group (BOOG))
  • KWF UM 2014-6679 (Other Grant/Funding Number: The Dutch Cancer Society (KWF))

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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