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

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ClinicalTrials.gov Identifier: NCT02112682
Recruitment Status : Terminated (slow accrual rate)
First Posted : April 14, 2014
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center

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 Phase
Breast Neoplasms Procedure: Completion axillary treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 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
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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).



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

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

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


Locations
Netherlands
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6202 AZ
Flevoziekenhuis
Almere, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Amphia ziekenhuis
Breda, Netherlands
Reinier de Graaf
Delft, Netherlands
Jeroen Bosch ziekenhuis
Den Bosch, Netherlands
Bronovo / Medisch Centrum Haaglanden
Den Haag, Netherlands
Haga Ziekenhuis
Den Haag, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
UMC Groningen
Groningen, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Tergooi
Hilversum, Netherlands
Alrijne ziekenhuis
Leiden, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Radboud university medical center
Nijmegen, Netherlands
Laurentius Ziekenhuis
Roermond, Netherlands
Zuyderland Medisch Centrum
Sittard, Netherlands
Antonius Ziekenhuis
Sneek, Netherlands
Rivierenland
Tiel, Netherlands
St. Elisabeth Ziekenhuis
Tilburg, Netherlands
Diakonessenhuis Utrecht
Utrecht, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Isala Klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Borstkanker Onderzoek Groep
Dutch Cancer Society
Maastricht University
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 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: May 9, 2018
Last Verified: May 2018

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
Neoplasms
Breast Diseases
Skin Diseases