We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02112682
Recruitment Status : Recruiting
First Posted : April 14, 2014
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Breast Neoplasms Procedure: Completion axillary treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy. A Dutch Randomized Controlled Multicentre Trial.
Study Start Date : June 2014
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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).

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112682

Contact: Marjolein L Smidt, MD, PhD +31433877477

Maastricht University Medical Centre+ Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Marjolein L Smidt, MD, PhD    +31433877477      
Principal Investigator: Marjolein L Smidt, MD, PhD         
Flevoziekenhuis Not yet recruiting
Almere, Netherlands
Meander Medisch Centrum Recruiting
Amersfoort, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands
Gelre Ziekenhuizen Recruiting
Apeldoorn, Netherlands
Rijnstate Recruiting
Arnhem, Netherlands
Amphia ziekenhuis Not yet recruiting
Breda, Netherlands
Reinier de Graaf Recruiting
Delft, Netherlands
Jeroen Bosch ziekenhuis Not yet recruiting
Den Bosch, Netherlands
Bronovo / Medisch Centrum Haaglanden Not yet recruiting
Den Haag, Netherlands
Haga Ziekenhuis Recruiting
Den Haag, Netherlands
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
Catharina Ziekenhuis Eindhoven Recruiting
Eindhoven, Netherlands
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Groene Hart Ziekenhuis Recruiting
Gouda, Netherlands
Martini Ziekenhuis Recruiting
Groningen, Netherlands
UMC Groningen Not yet recruiting
Groningen, Netherlands
Zuyderland Medisch Centrum Recruiting
Heerlen, Netherlands
Tergooi Not yet recruiting
Hilversum, Netherlands
Alrijne ziekenhuis Not yet recruiting
Leiden, Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Canisius-Wilhelmina Ziekenhuis Recruiting
Nijmegen, Netherlands
Radboud university medical center Recruiting
Nijmegen, Netherlands
Laurentius Ziekenhuis Recruiting
Roermond, Netherlands
Zuyderland Medisch Centrum Recruiting
Sittard, Netherlands
Antonius Ziekenhuis Recruiting
Sneek, Netherlands
Rivierenland Recruiting
Tiel, Netherlands
St. Elisabeth Ziekenhuis Not yet recruiting
Tilburg, Netherlands
Diakonessenhuis Utrecht Recruiting
Utrecht, Netherlands
Maxima Medisch Centrum Recruiting
Veldhoven, Netherlands
Isala Klinieken Recruiting
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02112682     History of Changes
Other Study ID Numbers: BOOG 2013-07
KWF UM 2013-5920 ( Other Grant/Funding Number: Dutch Cancer Society (in Dutch: KWF Kankerbestrijding) )
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: March 2017

Keywords provided by Maastricht University Medical Center:
Sentinel lymph node metastasis
Completion axillary lymph node dissection
Axillary radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases