Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy

May 3, 2018 updated by: Maastricht University Medical Center

The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.

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

PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.

HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • Netherlands
      • Almere, Netherlands
        • Flevoziekenhuis
      • Amersfoort, Netherlands
        • Meander Medisch Centrum
      • Amsterdam, Netherlands
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuizen
      • Arnhem, Netherlands
        • Rijnstate
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Den Haag, Netherlands
        • Haga ziekenhuis
      • Den Haag, Netherlands
        • Bronovo / Medisch Centrum Haaglanden
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis Eindhoven
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Gouda, Netherlands
        • Groene Hart Ziekenhuis
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Groningen, Netherlands
        • UMC Groningen
      • Heerlen, Netherlands
        • Zuyderland Medisch Centrum
      • Hilversum, Netherlands
        • Tergooi
      • Leiden, Netherlands
        • Alrijne Ziekenhuis
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • Radboud University Medical Center
      • Nijmegen, Netherlands
        • Canisius-Wilhelmina Ziekenhuis
      • Roermond, Netherlands
        • Laurentius Ziekenhuis
      • Sittard, Netherlands
        • Zuyderland Medisch Centrum
      • Sneek, Netherlands
        • Antonius Ziekenhuis
      • Tiel, Netherlands
        • Rivierenland
      • Tilburg, Netherlands
        • St. Elisabeth Ziekenhuis
      • Utrecht, Netherlands
        • Diakonessenhuis Utrecht
      • Veldhoven, Netherlands
        • Máxima Medisch Centrum
      • Zwolle, Netherlands
        • Isala Klinieken
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Centre+

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

16 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 unilateral breast carcinoma
  • A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
  • Will be or is treated with mastectomy
  • Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
  • Sentinel lymph node procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
  • pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
  • Written informed consent

Exclusion Criteria:

  • Clinically node positive pre-operative
  • Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
  • Solitary parasternal sentinel lymph node metastasis (pN1b)
  • Bilateral breast cancer
  • Irradical resection of primary tumour at time of randomization (applicable in case the mastectomy is performed before randomization)
  • 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: Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
Procedure: Completion axillary treatment
Completion axillary treatment according to the Dutch breast cancer guideline
No Intervention: No completion axillary treatment

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

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

June 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOOG 2013-07
  • KWF UM 2013-5920 (Other Grant/Funding Number: Dutch Cancer Society (in Dutch: KWF Kankerbestrijding))

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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